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A Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+Obinutuzumab (GA101) in Participants With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma (GADOLIN)

Primary Purpose

Non-Hodgkin's Lymphoma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Obinutuzumab

Bendamustine

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring follicular, follicular lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

History of histologically documented, B-lymphocyte antigen cluster of differentiation 20 plus (CD20+), iNHL
Refractory to any previous regimen containing rituximab (defined by participants who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen)
Previously treated with a maximum of four unique chemotherapy containing treatment regimens
All participants must have at least one bi-dimensionally measurable lesion (greater than [>]1.5 centimeters (cm) in its largest dimension by computed tomography [CT] scan)

Exclusion Criteria:

Prior use of any monoclonal antibody (other than anti-CD20) within 3 months prior to the start of Cycle 1, prior treatment with obinutuzumab was not allowed
Chemotherapy or other investigational therapy within 28 days prior to the start of Cycle 1
Prior treatment with bendamustine (within 2 years of the start of Cycle 1)
Prior allogeneic stem cell transplant
History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
History of sensitivity to mannitol
Central nervous system lymphoma or prior diffuse large B-cell lymphoma (DLBCL), histological evidence of transformation to high grade or diffuse large B-cell lymphoma
History of other malignancy that could affect compliance with the protocol or interpretation of results
Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with intravenous antibiotics or hospitalization within 4 weeks
Participants with a history of confirmed progressive multifocal leukoencephalopathy (PML)
Vaccination with a live vaccine a minimum of 28 days prior to randomization
Recent major surgery (within 4 weeks), other than for diagnosis
Presence of positive test results for Hepatitis B surface antigen (HBsAg); antibody to hepatitis B core antigen [anti-HBc]) with detectable viral load (positive hepatitis B virus [HBV] deoxyribo-nucleic acid [DNA]) or Hepatitis C
Participants with chronic hepatitis B or seropositive occult (HBV) infection
Participants with seronegative occult HBV infection or past HBV infection (defined as anti-HBc positive and HBV DNA negative) could be eligible if they were willing to be followed according to the protocol for HBV DNA testing
Participants positive for Hepatitis C virus (HCV) antibody were eligible only if polymerase chain reaction(PCR) was negative for HCV Ribonucleic acid (RNA)
Known history of human immunodeficiency virus (HIV) seropositive status
Positive test results for human T-lymphotropic virus type I (HTLV 1) virus in endemic countries
Women who are pregnant or lactating
Fertile men or women of childbearing potential unless 1) surgically sterile or 2) using an adequate measure of contraception such as oral contraceptives, intrauterine device, or barrier method of contraception in conjunction with spermicidal jelly
Ongoing corticosteroid use >30 milligrams per day (mg/day) prednisone or equivalent

Sites / Locations

Southern Cancer Center, PC
Dr. Donald W. Hill, MD, FACP
Highlands Oncology Group
Kaiser Permanente - Bellflower
Bay Area Cancer Research Group, LLC
Sharp Memorial Hospital
Georgetown University Medical Center Lombardi Cancer Center
Washington DC VA Med Center; Hematology
University of Florida
University of Florida; Division of Hematology/Oncology
Md Anderson Cancer Center Orlando
Rush Cancer Institute
Quincy Medical Group
Simmons Cancer Institute
University of Iowa
Univ Louisville School of Med
New England Cancer Specialists
Meritus Center for Clinical Research
Capitol Comprehensive CA Care
Hackensack University Medical Center
Hematology Oncology Assoc SJ
San Juan Oncology
The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc.
OHSU Knight Cancer Institute
Pacific Oncology, PC
OHSU Ctr for Health & Healing
Thomas Jefferson University Hospital
Western Pennsylvania Hospital
Sanford Health System
South Texas Inst of Cancer
University of Texas M.D. Anderson Cancer Center
Fred Hutchinson Cancer Research Center
Univ of Wisconsin Hosp & Clin
Lkh-Univ. Klinikum Graz
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
Medizinische Universität Wien
ZNA Stuivenberg
AZ Groeninge
CHU Ambroise Paré
Cross Cancer Institute
British Columbia Cancer Agency
British Columbia Cancer Agency
Manitoba Cancer Care
Moncton Hospital
Toronto East General Hospital; Main Pharmacy G Wing Basement
Princess Margaret Hospital
CHUM-Hosp Notre Dame
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
CHA Hopital de I enfant-Jesus
Allan Blair Cancer Centre
Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika
Fakultni nemocnice Hradec Kralove
I Interni klinika; Vseobecna fakultni nemocnice
Institut Bergonie; Hematologie Oncologie
Polyclinique Bordeaux Nord
Hopital Henri Mondor
CH Dijon
Centre d'oncologie-radiotherap
Hopital Claude Huriez
Centre Leon Berard
Hopital Bon Secour
CHU Hopital Saint Eloi
Hopital Hotel Dieu Et Hme; Clinique Dermatologique
Hopital Necker
Hopital Saint Louis; Dermatologie 1
CHU Bordeaux
Centre Hospitalier Lyon Sud; Hematolgie
Chu De Poitiers; Chu La Miletrie
CHU de Reims
Hopital Pontchaillou
Centre Henri Becquerel
Clinique Ste Anne
CHRU de; Maladies, Vasculaires
St. Johannes Hospital Duisburg
Klinikum Frankfurt Höchst
Asklepios Klinik St. Georg
Universitaetsklinikum Leipzig
Klinikum der Universitat Munchen, Campus Grobhadern;; Medizinische Klinik und Poliklinik III
Schwarzwald-Baar Klinikum GmbH
Azienda Ospedaliera Universitaria di Modena
Azienda Ospedaliera Univ, Ematologica
Azienda Ospedaliera Univ
Universita La Sapienza
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
Irccs Policlinico San Matteo; Divisione Di Ematologia
Azienda Ospedale San Giovanni
Ospedale Mauriziano Umberto I
Ospedale Vito Fazzi
Azienda Ospedaliero Univ
Azienda Ospedaliera Univ
VU MEDISCH CENTRUM; Dept. of Medical Oncology
Haga Ziekenhuis
Albert Schweitzer Ziekenhuis
Universitair Medisch Centrum Groningen
Erasmus Mc - Daniel Den Hoed Kliniek; Medical Oncology
Erasmus MC
Regional Oncology Hospital
Blokhin Cancer Research Center; Combined Treatment
City Clin Hosp n.a. S.P.Botkin
Russian Hema Res Ctr of RAMS
Republican Clinical Hospital n.a. Baranov; Haematology
Ryazan Regional Clinical Hosp
St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta
SRI of Hematology and Transfusiology
Clinica Universitaria de Navarra
Hospital Univ. Nuestra Señora de Valme;
Hospital Universitario Basurto
Hospital Universitario de la Princesa; Servicio de Hematologia
Hospital Universitario La Paz
Skånes University Hospital, Skånes Department of Onclology
Hematology Center; Karolinska Univ Hosp
Norrlands Uni Hospital; Onkologi Avd.
Onc Clin, Akademiska Sjukhuset
Universitaetsspital Basel; Onkologie
Inselspital Bern; Universitätsklinik für medizinische Onkologie
Kantonsspital Graubünden;Onkologie und Hämatologie
Beatson West of Scotland Cancer Centre
Leicester Royal Infirmary
Barts & London School of Med; Medical Oncology
Freeman Hospital
Singleton Hospital; Pharmacy Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Bendamustine Alone

Obinutuzumab + Bendamustine

Arm Description

Participants will receive bendamustine 120 milligrams per meter square (mg/m^2) Intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.

Induction phase: Participants will receive bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants will also receive obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with complete response (CR), partial response (PR) or stable response (SD) then will receive obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurs first).

Outcomes

Primary Outcome Measures

Number of Participants With Progressive Disease (PD) as Assessed by Independent Review Committee (IRC) or Death

PD was assessed by an IRC according to the modified response criteria for indolent Non-Hodgkin's Lymphoma (iNHL) (Modified Cheson et al, 2007). PD was defined as appearance of any new lesion more than 1.5 centimeters (cm) in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50 percent (%) increase from nadir in the sum of product diameter (SPD) of any previously involved nodes, or in a single involved node, or the size of other lesions (example: splenic or hepatic nodules). To be considered PD, a lymph node with a diameter of the short axis of less than (<) 1.0 cm must increase by greater than or equal to (≥) 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node greater than (>) 1 cm in its short axis.

Progression-Free Survival (PFS) as Assessed by IRC

PFS was defined as the time from randomization to the first occurrence of PD or death as assessed by an IRC according to the modified response criteria for iNHL (Modified Cheson et al, 2007). PD was defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). To be PD, a lymph node with a diameter of the short axis of <1.0 cm must increase by ≥ 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node >1 cm in its short axis. PFS was estimated using Kaplan-Meier method and 95% confidence interval (CI) for median was computed using the method of Brookmeyer and Crowley.

Secondary Outcome Measures

Number of Participants With PD or Death as Assessed by Investigator

PD was assessed by an investigator according to the modified response criteria for iNHL (Modified Cheson et al, 2007). PD was defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). To be considered PD, a lymph node with a diameter of the short axis of <1.0 cm must increase by ≥ 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node >1 cm in its short axis.

PFS as Assessed by Investigator

PFS was defined as the time from randomization to the first occurrence of PD as assessed by an investigator according to the modified response criteria for iNHL (Modified Cheson et al, 2007), or death from any cause on study. PD was defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). To be considered PD, a lymph node with a diameter of the short axis of <1.0 cm must increase by ≥ 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node >1 cm in its short axis. PFS was estimated using Kaplan-Meier method and 95% CI for median was computed using the method of Brookmeyer and Crowley.

Percentage of Participants With Objective Response as Assessed by IRC

Objective response was defined as having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. IRC review was performed up clinical cutoff date of to 1 May 2015.

Percentage of Participants With Objective Response as Assessed by Investigator

Percentage of Participants With Best Overall Response (BOR) as Assessed by IRC

BOR observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease & disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by baseline scan & no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic & hepatic nodules, involvement of other organs is usually assessable & no measurable disease should be present, SD: Failing to attain criteria needed for a CR/PR, but not fulfilling those for PD, PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in SPD of any previously involved nodes, or in single involved node, or size of other lesions (e.g., splenic or hepatic nodules). IRC review was performed up clinical cutoff date of to 1 May 2015.

Percentage of Participants With Best Overall Response (BOR) as Assessed by Investigator

BOR: best response for a participant, observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by baseline scan and no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present, SD: Failing to attain the criteria needed for a CR or PR, but not fulfilling those for PD, PD: appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in single involved node, or the size of other lesions (e.g., splenic or hepatic nodules).

Percentage of Participants With BOR at the End of Induction Treatment as Assessed by IRC

BOR observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease & disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan & no new sites; no increase in size of other nodes, liver or spleen; with exception of splenic & hepatic nodules, involvement of other organs is usually assessable & no measurable disease should be present, SD: Failing to attain criteria needed for a CR/PR, but not fulfilling those for PD, PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or size of other lesions (e.g., splenic/hepatic nodules). IRC review was performed up clinical cutoff date of to 1 May 2015.

Percentage of Participants With BOR at the End of Induction Treatment as Assessed by Investigator

BOR: best response for a participant, observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present, SD: Failing to attain criteria needed for a CR or PR, but not fulfilling those for PD, PD: appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules).

Percentage of Participants With Objective Response at the End of Induction Treatment as Assessed by IRC

Percentage of Participants With Objective Response at the End of Induction Treatment as Assessed by Investigator

Duration of Response (DoR) as Assessed by IRC

DoR: time from first objective response of CR/PR to first occurrence of PD/relapse/death from any cause. CR: Complete disappearance of all detectable evidence of disease & disease-related symptoms if present before therapy; liver, spleen returned to normal size; if bone marrow involved by lymphoma before treatment, infiltrate must be cleared on repeat bone marrow biopsy. PR: at least 50% measurable disease regressed vs. to baseline scan and no new sites; no increase in size of other nodes/liver/spleen, exception: splenic, hepatic nodules; other organs involved is usually assessable; no measurable disease present. PD: any new lesion >1.5 cm in any axis appear during or at end of therapy, even if other lesions are decreasing in size; at least 50% increase from nadir in SPD of any previously involved nodes, or in single involved node, or size of other lesions. DoR estimated using Kaplan-Meier method. IRC review performed up to clinical cutoff date 1 May 2015.

Duration of Response (DoR) as Assessed by Investigator

DoR: time from first objective response of CR/PR to first occurrence of PD/relapse/death from any cause. CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy; liver, spleen returned to normal size (if enlarged at baseline); if bone marrow was involved by lymphoma prior to treatment, infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to baseline scan and no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic, hepatic nodules; involvement of other organs is usually assessable; no presence of measurable disease. PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least 50% increase from nadir in SPD of any previously involved nodes, or in single involved node, or size of other lesions. DoR was estimated using Kaplan-Meier method.

Disease-Free Survival (DFS) in Participants With CR as Assessed by IRC

DFS was defined as the time from the first occurrence of a documented CR until progression on the basis of the IRC assessments (as per modified response criteria for iNHL [Modified Cheson et al, 2007]) or death from any cause on study. CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in SPD of any previously involved nodes, or in a single involved node, or size of other lesions. DFS was estimated using Kaplan-Meier method. IRC review was performed up clinical cutoff date of to 1 May 2015.

Disease-Free Survival (DFS) in Participants With CR as Assessed by Investigator

Event-free Survival (EFS) as Assessed by IRC

EFS was defined as the time between the date of randomization and the date of PD/relapse based on IRC assessments (as per modified response criteria for iNHL [Modified Cheson et al, 2007]), death from any cause on study, or start of a new anti-lymphoma therapy. PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in SPD of any previously involved nodes, or in a single involved node, or size of other lesions. EFS was estimated using Kaplan-Meier method. IRC review was performed up clinical cutoff date of to 1 May 2015.

Percentage of Participants Who Died

Overall Survival (OS)

OS was defined as the time between the date of randomization and the date of death from any cause. OS was estimated using Kaplan-Meier method and 95% CI for median was computed using the method of Brookmeyer and Crowley.

Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score

The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-168. Physical Well-being sub-scale includes 7 items measured on 0-4 point scale. The total score for physical well-being sub-scale is sum of each 7 items (range: 0-28). Higher scores indicate a better participant-reported outcome (PRO)/quality of life (QoL). In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).

CFB in FACT-Lym-Social/Family Well-being Sub-scale Score

The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-168. Social/family Well-being sub-scale includes 7 items measured on 0-4 point scale. The total score for social/family well-being sub-scale is sum of each 7 items (range: 0-28). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).

CFB in FACT-Lym-Emotional Well-Being Sub-scale Score

The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-168. Emotional Well-being sub-scale includes 6 items measured on 0-4 point scale. The total score for emotional well-being sub-scale is sum of each 6 items (range: 0-24). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).

CFB in FACT-Lym-Functional Well-Being Sub-scale Score

The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-168. Functional Well-being sub-scale includes 7 items measured on 0-4 point scale. The total score for functional well-being sub-scale is sum of each 7 items (range: 0-28). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).

CFB in FACT-Lym-Lymphoma Sub-scale Score

The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-168. Lymphoma scale includes 15 items measured on 0-4 point scale. The total score for lymphoma sub-scale is sum of each 15 items (range: 0-60). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).

CFB in Euro Quality of Life 5 Dimension (EuroQoL-5D/EQ-5D) - Health State Profile Utility Score During Induction Phase

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). For 'Obinutuzumab + Bendamustine' arm, participants who had their follow-up Month 2 and 4 visits before start of maintenance treatment were reported in induction phase results under "CFB at Follow-up Month 2" and "CFB at Follow-up Month 4" categories.

CFB in EuroQol 5D (EQ-5D) - Health State Profile Utility Score During Maintenance Phase

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Data for this outcome was planned to be reported only for 'Obinutuzumab + Bendamustine' arm. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). Follow-up months were during maintenance phase.

CFB in EQ-5D Visual Analogue Scale (VAS) Score During Induction Phase

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). For 'Obinutuzumab + Bendamustine' arm, participants who had their follow-up Month 2 and 4 visits before start of maintenance treatment were reported in induction phase results under "CFB at Follow-up Month 2" and "CFB at Follow-up Month 4" categories.

CFB in EQ-5D VAS Score During Maintenance Phase

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. Data for this outcome was planned to be reported only for 'Obinutuzumab + Bendamustine' arm. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). Follow-up months were during maintenance phase.

CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score

The FACT-G is the sum of 4 sub-scales (physical, social, emotional and functional well-being) of FACT-Lym which includes total 27 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-108. Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).

CFB in FACT-Lym Trial Outcome Index (TOI)

TOI is the sum of 3 sub-scales (physical well-being, functional well-being, and Lymphoma sub-scale) of FACT-Lym which includes total 29 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-116. Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).

CFB in FACT-Lym Total Score

FACT-Lym total score is the sum of physical well-being score (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and Lymphoma sub-scale (15 items); responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-168. Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).

Time to Deterioration of FACT-Lym TOI

The median time, in month, from date of randomization until a clinically meaningful decline from baseline in TOI or death, whichever occurred first. TOI: sum of physical well-being score,functional well-being score, and Lymphoma sub-scale of FACT-Lym; total 29 items, responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-116. Higher scores indicate a better PRO/QoL. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from baseline. Time to deterioration was estimated using Kaplan-Meier method and 95% CI for median was computed using the method of Brookmeyer and Crowley. In timeframe, follow-up months represents months after end of induction (EOI) (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).

Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores

FACT-Lym: 42-items in 5 subscales. Responses to each item range from 0 (Not at all) to 4 (Very much). FACT-Lym Lymphoma subscale includes 15 items (total score range = 0-60). FACT-Lym TOI is sum of 3 subscales (physical well-being, functional well-being, lymphoma subscale) and includes 29 items (total score range = 0-116). FACT-Lym total score is sum of 42 items (total score ranges from 0-168). For all above, higher scores indicate a better PRO/QoL. DI from baseline: at least 3 point increase from baseline in FACT-Lym Lymphoma subscale; at least 6 point increase from baseline in FACT Lym TOI; at least 7 point increase from baseline in FACT Lym total scores. In timeframe, follow-up months represents months after EOI (e.g. Follow-up Month 2 is 2 months after EOI; EOI = up to Month 6).

Full Information

NCT ID

NCT01059630

First Posted

January 28, 2010

Last Updated

December 20, 2019

Sponsor

Genentech, Inc.

Collaborators

Roche Pharma AG

1. Study Identification

Unique Protocol Identification Number

NCT01059630

Brief Title

A Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+Obinutuzumab (GA101) in Participants With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma (GADOLIN)

Official Title

An Open-Label, Multicenter, Randomized, Phase III Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+RO5072759 (GA101) in Patients With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Completed

Study Start Date

April 30, 2010 (Actual)

Primary Completion Date

September 30, 2014 (Actual)

Study Completion Date

November 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Genentech, Inc.

Collaborators

Roche Pharma AG

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This open-label, multicenter, randomized Phase III study will investigate the efficacy, safety, pharmacokinetics and pharmacoeconomics of obinutuzumab (RO5072759, GA101) combined with bendamustine followed by continued obinutuzumab treatment (maintenance monotherapy) compared with bendamustine alone treatment in participants with rituximab-refractory indolent Non-Hodgkin's lymphoma (iNHL). The end of study was defined to when safety follow-up for all patients had been completed (2 years' safety follow-up from last dose).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Hodgkin's Lymphoma

Keywords

follicular, follicular lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

413 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bendamustine Alone

Arm Type

Active Comparator

Arm Description

Participants will receive bendamustine 120 milligrams per meter square (mg/m^2) Intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.

Arm Title

Obinutuzumab + Bendamustine

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Obinutuzumab

Other Intervention Name(s)

RO5072759; GA101

Intervention Description

IV infusion.

Intervention Type

Drug

Intervention Name(s)

Bendamustine

Intervention Description

IV infusion.

Primary Outcome Measure Information:

Title

Number of Participants With Progressive Disease (PD) as Assessed by Independent Review Committee (IRC) or Death

Description

Time Frame

Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cycle [Cy] 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1, then every 3 months up to 2 years and every 6 months for next 2 years [up to 4.5 years overall])

Title

Progression-Free Survival (PFS) as Assessed by IRC

Description

Time Frame

Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1, then every 3 months up to 2 years and every 6 months for next 2 years [up to 4.5 years overall])

Secondary Outcome Measure Information:

Title

Number of Participants With PD or Death as Assessed by Investigator

Description

Time Frame

Baseline until PD or death, whichever occurred first (up to 8.5 years overall))

Title

PFS as Assessed by Investigator

Description

Time Frame

Baseline until PD or death, whichever occurred first (up to 8.5 years overall)

Title

Percentage of Participants With Objective Response as Assessed by IRC

Description

Time Frame

Baseline until PD or death, whichever occurred first (up to approximately 5 years)

Title

Percentage of Participants With Objective Response as Assessed by Investigator

Description

Time Frame

Baseline until PD or death, whichever occurred first (up to approximately 8.5 years)

Title

Percentage of Participants With Best Overall Response (BOR) as Assessed by IRC

Description

Time Frame

Baseline until PD or death, whichever occurred first (up to approximately 5 years)

Title

Percentage of Participants With Best Overall Response (BOR) as Assessed by Investigator

Description

Time Frame

Baseline until PD or death, whichever occurred first (up to approximately 8.5 years)

Title

Percentage of Participants With BOR at the End of Induction Treatment as Assessed by IRC

Description

BOR observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease & disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan & no new sites; no increase in size of other nodes, liver or spleen; with exception of splenic & hepatic nodules, involvement of other organs is usually assessable & no measurable disease should be present, SD: Failing to attain criteria needed for a CR/PR, but not fulfilling those for PD, PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or size of other lesions (e.g., splenic/hepatic nodules). IRC review was performed up clinical cutoff date of to 1 May 2015.

Time Frame

Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1)

Title

Percentage of Participants With BOR at the End of Induction Treatment as Assessed by Investigator

Description

BOR: best response for a participant, observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present, SD: Failing to attain criteria needed for a CR or PR, but not fulfilling those for PD, PD: appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules).

Time Frame

Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1)

Title

Percentage of Participants With Objective Response at the End of Induction Treatment as Assessed by IRC

Description

Time Frame

Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1)

Title

Percentage of Participants With Objective Response at the End of Induction Treatment as Assessed by Investigator

Description

Time Frame

Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1)

Title

Duration of Response (DoR) as Assessed by IRC

Description

Time Frame

Baseline until PD or death, whichever occurred first (up to approximately 5 years)

Title

Duration of Response (DoR) as Assessed by Investigator

Description

Time Frame

Baseline until PD or death, whichever occurred first (up to approximately 8.5 years)

Title

Disease-Free Survival (DFS) in Participants With CR as Assessed by IRC

Description

Time Frame

Baseline until PD or death, whichever occurred first (up to approximately 5 years)

Title

Disease-Free Survival (DFS) in Participants With CR as Assessed by Investigator

Description

Time Frame

Baseline until PD or death, whichever occurred first (up to approximately 8.5 years)

Title

Event-free Survival (EFS) as Assessed by IRC

Description

Time Frame

Baseline until PD or death, whichever occurred first (up to approximately 5 years)

Title

Percentage of Participants Who Died

Time Frame

Baseline until death (up to 8.5 years overall)

Title

Overall Survival (OS)

Description

Time Frame

Baseline until death (up to 8.5 years overall)

Title

Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score

Description

Time Frame

Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24

Title

CFB in FACT-Lym-Social/Family Well-being Sub-scale Score

Description

Time Frame

Title

CFB in FACT-Lym-Emotional Well-Being Sub-scale Score

Description

Time Frame

Title

CFB in FACT-Lym-Functional Well-Being Sub-scale Score

Description

Time Frame

Title

CFB in FACT-Lym-Lymphoma Sub-scale Score

Description

Time Frame

Title

CFB in Euro Quality of Life 5 Dimension (EuroQoL-5D/EQ-5D) - Health State Profile Utility Score During Induction Phase

Description

Time Frame

Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4 and 14

Title

CFB in EuroQol 5D (EQ-5D) - Health State Profile Utility Score During Maintenance Phase

Description

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Data for this outcome was planned to be reported only for 'Obinutuzumab + Bendamustine' arm. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). Follow-up months were during maintenance phase.

Time Frame

Baseline, Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final follow-up (up to 2 years after end of induction) (End of induction = up to Month 6)

Title

CFB in EQ-5D Visual Analogue Scale (VAS) Score During Induction Phase

Description

Time Frame

Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4 and 14

Title

CFB in EQ-5D VAS Score During Maintenance Phase

Description

Time Frame

Baseline, Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction) (end of induction = up to Month 6)

Title

CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score

Description

Time Frame

Title

CFB in FACT-Lym Trial Outcome Index (TOI)

Description

Time Frame

Title

CFB in FACT-Lym Total Score

Description

Time Frame

Title

Time to Deterioration of FACT-Lym TOI

Description

Time Frame

Baseline up to approximately 8.5 years

Title

Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores

Description

Time Frame

Baseline, Cycle 5 Day 1 (C5D1) (Cycle length = 28 days), Follow-up Months 6 (FUM6), 12 (FUM12), 18 (FUM18), 24 (FUM24), Extension Follow Up Month 6 (Extension FUM6)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: History of histologically documented, B-lymphocyte antigen cluster of differentiation 20 plus (CD20+), iNHL Refractory to any previous regimen containing rituximab (defined by participants who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen) Previously treated with a maximum of four unique chemotherapy containing treatment regimens All participants must have at least one bi-dimensionally measurable lesion (greater than [>]1.5 centimeters (cm) in its largest dimension by computed tomography [CT] scan) Exclusion Criteria: Prior use of any monoclonal antibody (other than anti-CD20) within 3 months prior to the start of Cycle 1, prior treatment with obinutuzumab was not allowed Chemotherapy or other investigational therapy within 28 days prior to the start of Cycle 1 Prior treatment with bendamustine (within 2 years of the start of Cycle 1) Prior allogeneic stem cell transplant History of severe allergic or anaphylactic reactions to monoclonal antibody therapy History of sensitivity to mannitol Central nervous system lymphoma or prior diffuse large B-cell lymphoma (DLBCL), histological evidence of transformation to high grade or diffuse large B-cell lymphoma History of other malignancy that could affect compliance with the protocol or interpretation of results Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with intravenous antibiotics or hospitalization within 4 weeks Participants with a history of confirmed progressive multifocal leukoencephalopathy (PML) Vaccination with a live vaccine a minimum of 28 days prior to randomization Recent major surgery (within 4 weeks), other than for diagnosis Presence of positive test results for Hepatitis B surface antigen (HBsAg); antibody to hepatitis B core antigen [anti-HBc]) with detectable viral load (positive hepatitis B virus [HBV] deoxyribo-nucleic acid [DNA]) or Hepatitis C Participants with chronic hepatitis B or seropositive occult (HBV) infection Participants with seronegative occult HBV infection or past HBV infection (defined as anti-HBc positive and HBV DNA negative) could be eligible if they were willing to be followed according to the protocol for HBV DNA testing Participants positive for Hepatitis C virus (HCV) antibody were eligible only if polymerase chain reaction(PCR) was negative for HCV Ribonucleic acid (RNA) Known history of human immunodeficiency virus (HIV) seropositive status Positive test results for human T-lymphotropic virus type I (HTLV 1) virus in endemic countries Women who are pregnant or lactating Fertile men or women of childbearing potential unless 1) surgically sterile or 2) using an adequate measure of contraception such as oral contraceptives, intrauterine device, or barrier method of contraception in conjunction with spermicidal jelly Ongoing corticosteroid use >30 milligrams per day (mg/day) prednisone or equivalent

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Genentech, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Southern Cancer Center, PC

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36608

Country

United States

Facility Name

Dr. Donald W. Hill, MD, FACP

City

Casa Grande

State/Province

Arizona

ZIP/Postal Code

85122

Country

United States

Facility Name

Highlands Oncology Group

City

Rogers

State/Province

Arkansas

ZIP/Postal Code

72758

Country

United States

Facility Name

Kaiser Permanente - Bellflower

City

Bellflower

State/Province

California

ZIP/Postal Code

90706

Country

United States

Facility Name

Bay Area Cancer Research Group, LLC

City

Pleasant Hill

State/Province

California

ZIP/Postal Code

94523

Country

United States

Facility Name

Sharp Memorial Hospital

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Georgetown University Medical Center Lombardi Cancer Center

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Facility Name

Washington DC VA Med Center; Hematology

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20422

Country

United States

Facility Name

University of Florida

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32607

Country

United States

Facility Name

University of Florida; Division of Hematology/Oncology

City

Gainesville

State/Province

Florida

ZIP/Postal Code

33610-0277

Country

United States

Facility Name

Md Anderson Cancer Center Orlando

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Rush Cancer Institute

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

Quincy Medical Group

City

Quincy

State/Province

Illinois

ZIP/Postal Code

62301

Country

United States

Facility Name

Simmons Cancer Institute

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62794-9677

Country

United States

Facility Name

University of Iowa

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Facility Name

Univ Louisville School of Med

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

New England Cancer Specialists

City

Scarborough

State/Province

Maine

ZIP/Postal Code

04074

Country

United States

Facility Name

Meritus Center for Clinical Research

City

Hagerstown

State/Province

Maryland

ZIP/Postal Code

21740

Country

United States

Facility Name

Capitol Comprehensive CA Care

City

Jefferson City

State/Province

Missouri

ZIP/Postal Code

65101

Country

United States

Facility Name

Hackensack University Medical Center

City

Hackensack

State/Province

New Jersey

ZIP/Postal Code

07601

Country

United States

Facility Name

Hematology Oncology Assoc SJ

City

Mount Holly

State/Province

New Jersey

ZIP/Postal Code

08060

Country

United States

Facility Name

San Juan Oncology

City

Farmington

State/Province

New Mexico

ZIP/Postal Code

87401

Country

United States

Facility Name

The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc.

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43219

Country

United States

Facility Name

OHSU Knight Cancer Institute

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

Country

United States

Facility Name

Pacific Oncology, PC

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

Country

United States

Facility Name

OHSU Ctr for Health & Healing

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Thomas Jefferson University Hospital

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

Western Pennsylvania Hospital

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15224

Country

United States

Facility Name

Sanford Health System

City

Sioux Falls

State/Province

South Dakota

ZIP/Postal Code

57105

Country

United States

Facility Name

South Texas Inst of Cancer

City

Corpus Christi

State/Province

Texas

ZIP/Postal Code

78405

Country

United States

Facility Name

University of Texas M.D. Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Fred Hutchinson Cancer Research Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

Facility Name

Univ of Wisconsin Hosp & Clin

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792

Country

United States

Facility Name

Lkh-Univ. Klinikum Graz

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

Medizinische Universität Wien

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

ZNA Stuivenberg

City

Antwerpen

ZIP/Postal Code

2060

Country

Belgium

Facility Name

AZ Groeninge

City

Kortrijk

ZIP/Postal Code

8500

Country

Belgium

Facility Name

CHU Ambroise Paré

City

Mons

ZIP/Postal Code

7000

Country

Belgium

Facility Name

Cross Cancer Institute

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

Facility Name

British Columbia Cancer Agency

City

Kelowna

State/Province

British Columbia

ZIP/Postal Code

V1Y 5L3

Country

Canada

Facility Name

British Columbia Cancer Agency

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 1H6

Country

Canada

Facility Name

Manitoba Cancer Care

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3E 0V9

Country

Canada

Facility Name

Moncton Hospital

City

Moncton

State/Province

New Brunswick

ZIP/Postal Code

E1C 6Z8

Country

Canada

Facility Name

Toronto East General Hospital; Main Pharmacy G Wing Basement

City

East York

State/Province

Ontario

ZIP/Postal Code

M4C 3E7

Country

Canada

Facility Name

Princess Margaret Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4X 1K9

Country

Canada

Facility Name

CHUM-Hosp Notre Dame

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2X 3E4

Country

Canada

Facility Name

McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1E2

Country

Canada

Facility Name

CHA Hopital de I enfant-Jesus

City

Quebec City

State/Province

Quebec

ZIP/Postal Code

G1J 1Z4

Country

Canada

Facility Name

Allan Blair Cancer Centre

City

Regina

State/Province

Saskatchewan

ZIP/Postal Code

S4T 7T1

Country

Canada

Facility Name

Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika

City

Brno

ZIP/Postal Code

625 00

Country

Czechia

Facility Name

Fakultni nemocnice Hradec Kralove

City

Hradec Kralove

ZIP/Postal Code

500 05

Country

Czechia

Facility Name

I Interni klinika; Vseobecna fakultni nemocnice

City

Prague 2

ZIP/Postal Code

128 08

Country

Czechia

Facility Name

Institut Bergonie; Hematologie Oncologie

City

Bordeaux

ZIP/Postal Code

33076

Country

France

Facility Name

Polyclinique Bordeaux Nord

City

Bordeaux

ZIP/Postal Code

33300

Country

France

Facility Name

Hopital Henri Mondor

City

Creteil

ZIP/Postal Code

94010

Country

France

Facility Name

CH Dijon

City

Dijon

ZIP/Postal Code

21079

Country

France

Facility Name

Centre d'oncologie-radiotherap

City

LeMans

ZIP/Postal Code

72015

Country

France

Facility Name

Hopital Claude Huriez

City

Lille

ZIP/Postal Code

59037

Country

France

Facility Name

Centre Leon Berard

City

Lyon

ZIP/Postal Code

69008

Country

France

Facility Name

Hopital Bon Secour

City

Metz

ZIP/Postal Code

57038

Country

France

Facility Name

CHU Hopital Saint Eloi

City

Montpellier

ZIP/Postal Code

34295

Country

France

Facility Name

Hopital Hotel Dieu Et Hme; Clinique Dermatologique

City

Nantes

ZIP/Postal Code

44093

Country

France

Facility Name

Hopital Necker

City

Paris

ZIP/Postal Code

75015

Country

France

Facility Name

Hopital Saint Louis; Dermatologie 1

City

Paris

ZIP/Postal Code

75475

Country

France

Facility Name

CHU Bordeaux

City

Pessac

ZIP/Postal Code

33604

Country

France

Facility Name

Centre Hospitalier Lyon Sud; Hematolgie

City

Pierre Benite

ZIP/Postal Code

69495

Country

France

Facility Name

Chu De Poitiers; Chu La Miletrie

City

Poitiers

ZIP/Postal Code

86021

Country

France

Facility Name

CHU de Reims

City

Reims

ZIP/Postal Code

51100

Country

France

Facility Name

Hopital Pontchaillou

City

Rennes

ZIP/Postal Code

35033

Country

France

Facility Name

Centre Henri Becquerel

City

Rouen

ZIP/Postal Code

76038

Country

France

Facility Name

Clinique Ste Anne

City

Strasbourg

ZIP/Postal Code

67000

Country

France

Facility Name

CHRU de; Maladies, Vasculaires

City

Vandoeuvre

ZIP/Postal Code

54511

Country

France

Facility Name

St. Johannes Hospital Duisburg

City

Duisburg

ZIP/Postal Code

47166

Country

Germany

Facility Name

Klinikum Frankfurt Höchst

City

Frankfurt am Main

ZIP/Postal Code

65929

Country

Germany

Facility Name

Asklepios Klinik St. Georg

City

Hamburg

ZIP/Postal Code

20099

Country

Germany

Facility Name

Universitaetsklinikum Leipzig

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Klinikum der Universitat Munchen, Campus Grobhadern;; Medizinische Klinik und Poliklinik III

City

München

ZIP/Postal Code

81377

Country

Germany

Facility Name

Schwarzwald-Baar Klinikum GmbH

City

Villingen-Schwenningen

ZIP/Postal Code

78052

Country

Germany

Facility Name

Azienda Ospedaliera Universitaria di Modena

City

Modena

State/Province

Emilia-Romagna

ZIP/Postal Code

41100

Country

Italy

Facility Name

Azienda Ospedaliera Univ, Ematologica

City

Udine

State/Province

Friuli-Venezia Giulia

ZIP/Postal Code

33100

Country

Italy

Facility Name

Azienda Ospedaliera Univ

City

Roma

State/Province

Lazio

ZIP/Postal Code

00133

Country

Italy

Facility Name

Universita La Sapienza

City

Roma

State/Province

Lazio

ZIP/Postal Code

00161

Country

Italy

Facility Name

Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20133

Country

Italy

Facility Name

Irccs Policlinico San Matteo; Divisione Di Ematologia

City

Pavia

State/Province

Lombardia

ZIP/Postal Code

27100

Country

Italy

Facility Name

Azienda Ospedale San Giovanni

City

Torino

State/Province

Piemonte

ZIP/Postal Code

10126

Country

Italy

Facility Name

Ospedale Mauriziano Umberto I

City

Torino

State/Province

Piemonte

ZIP/Postal Code

10128

Country

Italy

Facility Name

Ospedale Vito Fazzi

City

Lecce

State/Province

Puglia

ZIP/Postal Code

73100

Country

Italy

Facility Name

Azienda Ospedaliero Univ

City

Catania

State/Province

Sicilia

ZIP/Postal Code

95124

Country

Italy

Facility Name

Azienda Ospedaliera Univ

City

Firenze

State/Province

Toscana

ZIP/Postal Code

50141

Country

Italy

Facility Name

VU MEDISCH CENTRUM; Dept. of Medical Oncology

City

Amsterdam

ZIP/Postal Code

1081 HV

Country

Netherlands

Facility Name

Haga Ziekenhuis

City

Den Haag

ZIP/Postal Code

2504 LN

Country

Netherlands

Facility Name

Albert Schweitzer Ziekenhuis

City

Dordrecht

ZIP/Postal Code

3371 NM

Country

Netherlands

Facility Name

Universitair Medisch Centrum Groningen

City

Groningen

ZIP/Postal Code

9713 GZ

Country

Netherlands

Facility Name

Erasmus Mc - Daniel Den Hoed Kliniek; Medical Oncology

City

Rotterdam

ZIP/Postal Code

3015 CE

Country

Netherlands

Facility Name

Erasmus MC

City

Rotterdam

ZIP/Postal Code

3015 GD

Country

Netherlands

Facility Name

Regional Oncology Hospital

City

Irkutsk

ZIP/Postal Code

664035

Country

Russian Federation

Facility Name

Blokhin Cancer Research Center; Combined Treatment

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

City Clin Hosp n.a. S.P.Botkin

City

Moscow

ZIP/Postal Code

125101

Country

Russian Federation

Facility Name

Russian Hema Res Ctr of RAMS

City

Moscow

ZIP/Postal Code

125167

Country

Russian Federation

Facility Name

Republican Clinical Hospital n.a. Baranov; Haematology

City

Petrozavodsk

ZIP/Postal Code

185019

Country

Russian Federation

Facility Name

Ryazan Regional Clinical Hosp

City

Ryazan

ZIP/Postal Code

390039

Country

Russian Federation

Facility Name

St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta

City

Saint-Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

SRI of Hematology and Transfusiology

City

St. Petersburg

ZIP/Postal Code

191024

Country

Russian Federation

Facility Name

Clinica Universitaria de Navarra

City

Pamplona

State/Province

Navarra

ZIP/Postal Code

31008

Country

Spain

Facility Name

Hospital Univ. Nuestra Señora de Valme;

City

Sevillac

State/Province

Sevilla

ZIP/Postal Code

41014

Country

Spain

Facility Name

Hospital Universitario Basurto

City

Bilbao

State/Province

Vizcaya

ZIP/Postal Code

48013

Country

Spain

Facility Name

Hospital Universitario de la Princesa; Servicio de Hematologia

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

Hospital Universitario La Paz

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Skånes University Hospital, Skånes Department of Onclology

City

Lund

ZIP/Postal Code

22185

Country

Sweden

Facility Name

Hematology Center; Karolinska Univ Hosp

City

Stockholm

ZIP/Postal Code

14186

Country

Sweden

Facility Name

Norrlands Uni Hospital; Onkologi Avd.

City

Umeå

ZIP/Postal Code

901 85

Country

Sweden

Facility Name

Onc Clin, Akademiska Sjukhuset

City

Uppsala

ZIP/Postal Code

751 85

Country

Sweden

Facility Name

Universitaetsspital Basel; Onkologie

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

Facility Name

Inselspital Bern; Universitätsklinik für medizinische Onkologie

City

Bern

ZIP/Postal Code

3010

Country

Switzerland

Facility Name

Kantonsspital Graubünden;Onkologie und Hämatologie

City

Chur

ZIP/Postal Code

7000

Country

Switzerland

Facility Name

Beatson West of Scotland Cancer Centre

City

Glasgow

ZIP/Postal Code

G12 0YN

Country

United Kingdom

Facility Name

Leicester Royal Infirmary

City

Leicester

ZIP/Postal Code

LE1 5WW

Country

United Kingdom

Facility Name

Barts & London School of Med; Medical Oncology

City

London

ZIP/Postal Code

EC1A 7BE

Country

United Kingdom

Facility Name

Freeman Hospital

City

Newcastle upon Tyne

ZIP/Postal Code

NE7 7DN

Country

United Kingdom

Facility Name

Singleton Hospital; Pharmacy Department

City

Swansea

ZIP/Postal Code

SA2 8QA

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

31462735

Citation

Pott C, Sehn LH, Belada D, Gribben J, Hoster E, Kahl B, Kehden B, Nicolas-Virelizier E, Spielewoy N, Fingerle-Rowson G, Harbron C, Mundt K, Wassner-Fritsch E, Cheson BD. MRD response in relapsed/refractory FL after obinutuzumab plus bendamustine or bendamustine alone in the GADOLIN trial. Leukemia. 2020 Feb;34(2):522-532. doi: 10.1038/s41375-019-0559-9. Epub 2019 Aug 28.

Results Reference

derived

PubMed Identifier

31050355

Citation

Gibiansky E, Gibiansky L, Buchheit V, Frey N, Brewster M, Fingerle-Rowson G, Jamois C. Pharmacokinetics, exposure, efficacy and safety of obinutuzumab in rituximab-refractory follicular lymphoma patients in the GADOLIN phase III study. Br J Clin Pharmacol. 2019 Sep;85(9):1935-1945. doi: 10.1111/bcp.13974. Epub 2019 Jul 12.

Results Reference

derived

PubMed Identifier

29584548

Citation

Cheson BD, Chua N, Mayer J, Dueck G, Trneny M, Bouabdallah K, Fowler N, Delwail V, Press O, Salles G, Gribben JG, Lennard A, Lugtenburg PJ, Fingerle-Rowson G, Mattiello F, Knapp A, Sehn LH. Overall Survival Benefit in Patients With Rituximab-Refractory Indolent Non-Hodgkin Lymphoma Who Received Obinutuzumab Plus Bendamustine Induction and Obinutuzumab Maintenance in the GADOLIN Study. J Clin Oncol. 2018 Aug 1;36(22):2259-2266. doi: 10.1200/JCO.2017.76.3656. Epub 2018 Mar 27.

Results Reference

derived

PubMed Identifier

27345636

Citation

Sehn LH, Chua N, Mayer J, Dueck G, Trneny M, Bouabdallah K, Fowler N, Delwail V, Press O, Salles G, Gribben J, Lennard A, Lugtenburg PJ, Dimier N, Wassner-Fritsch E, Fingerle-Rowson G, Cheson BD. Obinutuzumab plus bendamustine versus bendamustine monotherapy in patients with rituximab-refractory indolent non-Hodgkin lymphoma (GADOLIN): a randomised, controlled, open-label, multicentre, phase 3 trial. Lancet Oncol. 2016 Aug;17(8):1081-1093. doi: 10.1016/S1470-2045(16)30097-3. Epub 2016 Jun 23.

Results Reference

derived

Learn more about this trial

A Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+Obinutuzumab (GA101) in Participants With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma (GADOLIN)

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