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Comparison of the Treatments of Obinutuzumab + Venetoclax Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia

Primary Purpose

Lymphocytic Leukemia, Chronic

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Chlorambucil
Venetoclax
Obinutuzumab
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphocytic Leukemia, Chronic

Eligibility Criteria

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

Inclusion Criteria:

  • Documented previously untreated CLL according to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria
  • CLL requiring treatment according to IWCLL criteria
  • Total Cumulative Illness Rating Scale (CIRS score) greater than (>) 6
  • Adequate marrow function independent of growth factor or transfusion support within 2 weeks of screening as per protocol, unless cytopenia is due to marrow involvement of CLL
  • Adequate liver function
  • Life expectancy > 6 months
  • Agreement to use highly effective contraceptive methods per protocol

Exclusion Criteria:

  • Transformation of CLL to aggressive Non-Hodgkin's lymphoma (Richter's transformation or pro-lymphocytic leukemia)
  • Known central nervous system involvement
  • Participants with a history of confirmed progressive multifocal leukoencephalopathy (PML)
  • An individual organ/ system impairment score of 4 as assessed by the CIRS definition limiting the ability to receive the treatment regimen of this trial with the exception of eyes, ears, nose, throat organ system
  • Participants with uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia
  • Inadequate renal function
  • History of prior malignancy, except for conditions as listed in the protocol if participants have recovered from the acute side effects incurred as a result of previous therapy
  • Use of investigational agents or concurrent anti-cancer treatment within the last 4 weeks of registration
  • Participants with active bacterial, viral, or fungal infection requiring systemic treatment within the last two months prior to registration
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
  • Hypersensitivity to chlorambucil, obinutuzumab, or venetoclax or to any of the excipients
  • Pregnant women and nursing mothers
  • Positive test results for chronic hepatitis B virus (HBV) infection (defined as positive hepatitis B surface antigen [HBsAg] serology) or positive test result for hepatitis C (hepatitis C virus [HCV] antibody serology testing)
  • Participants with known infection with human immunodeficiency virus (HIV) or human T-cell leukemia virus-1 (HTLV-1)
  • Requires the use of warfarin, marcumar, or phenprocoumon
  • Received agents known to be strong and moderate Cytochrome P450 3A inhibitors or inducers within 7 days prior to the first dose of study drug

Sites / Locations

  • City of Hope
  • San Diego Pacific Hematology Assocates
  • UC San Diego Health System
  • Banner MD Anderson Cancer Center
  • Moffitt Cancer Center
  • Winship Cancer Institute
  • Ingalls Memorial Hospital
  • Henry Ford Hospital
  • Joe Arrington Cancer Center
  • Hospital Italiano
  • Liverpool Hospital
  • Tweed Hospital
  • The Townsville Hospital
  • Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology
  • Royal Adelaide Hospital; Haematology Clinical Trials
  • Ashford Cancer Centre Research; Internal Medicine/Medical Oncology
  • Box Hill Hospital
  • The Northern Hospital
  • Monash Medical Centre; Haematology
  • Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie
  • Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Hämatologie & Hämostaseologie
  • Hanusch-Krankenhaus; Iii. Medizinische Abt.
  • Wilhelminenspital; I. Medizinische Abt.
  • Hospital das Clinicas - UFRGS
  • Instituto de Ensino e Pesquisa Sao Lucas - IEP
  • Hospital Sírio-Libanês
  • Hospital das Clinicas - FMUSP
  • Hospital Santa Marcelina
  • UMHAT Dr Georgi Stranski; Hematology
  • UMHAT " Sveti Georgi" Plovdiv - Clinic of Oncology and Hematology
  • University Hospital Sv.Georgi Clnic of Hematology; Hematology
  • University Multiprofile Hospital For Active Treatment "Sveti Ivan Rilski" EAD; clinical hematology
  • MHAT Hristo Botev; First Internal Department
  • Tom Baker Cancer Centre; Dept of Medicine
  • Queen Elizabeth II Health Sciences Centre; Oncology
  • Jewish General Hospital
  • University Hospital Center Zagreb; Haematology Department
  • University Hospital Merkur Clinic for Internal Medicine/ Hematology
  • Herlev Hospital
  • Rigshospitalet
  • Sjællands Universitetshospital, Roskilde
  • Sygehus Lillebælt, Vejle
  • North Estonia medical Centre; Hematology
  • Tartu Uni Hospital; Hematology - Oncology Clinic
  • CHU Besançon - Hôpital Jean Minjoz
  • Institut d'Hématologie de Basse Normandie
  • Chu Estaing; Hematologie Clinique Adultes
  • Hopital Henri Mondor
  • CHU de Dijon - Hopital le Bocage
  • CHU de Grenoble
  • Centre Jean Bernard
  • Centre Leon Berard; Departement Oncologie Medicale
  • Hôpital Saint Eloi; Service d?Hématologie et Oncologie Clinique - Recherche Clinique
  • Hopital Hotel Dieu Et Hme;Hopital De Jour
  • Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset)
  • Hopital Pontchaillou; Hematologie Clinique
  • Centre Henri Becquerel; Hematologie
  • CH de Toulon Hôpital Sainte Musse
  • Institut Gustave Roussy - Hematologie
  • Uniklinik RWTH Aachen; Klinik IV; Klinik Hämatologie, Onkologie, Hämostaseologie und Stamm.
  • Gesundheitszentrum St. Marien GmbH; Med. II, Hämatologie/Onkologie
  • Charite - Universitätsmedizin Berlin
  • Charite - Campus Virchow-Klinikum
  • BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie
  • Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik und Poliklinik I
  • Universitätsklinikum Essen; Klinik für Hämatologie
  • Klinik Esslingen; Klinik für Allgemeine Innere Medizin, Onkologie/Haematologie
  • Klinikum Frankfurt/Oder
  • Uniklinikum Freiburg
  • Uni Göttingen, Georg-August-Universität; Klinik für Hämatologie und Medizinische Onkologie
  • Universitaetsklinikum Heidelberg
  • Stiftung Kathol. Krankenhaus Marienhospital Herne Klinik Mitte
  • Praxisklinik für Hämatologie und Onkologie Koblenz
  • Universitätsklinikum Köln; Innere Medizin I; Onkologie, Hämatologie
  • Tagesklinik Landshut; Hämatologie/Onkologie
  • Klinikum rechts der Isar der Technischen Universität München
  • Klinikum Schwäbisch Gmünd
  • Kliniken Maria Hilf GmbH; Innere Medizin I; Hämatologie und internistische Onkologie
  • München Klinik Schwabing; Klinik für Hämatologie, Onkologie, Immunologie
  • Klinikum der Universität München, Campus Großhadern; Medizinische Klinik und Poliklinik III
  • Gemeinschaftspraxis Dr. med. Holger Klaproth
  • Brüderkrankenhaus St. Josef Paderborn
  • Krankenhaus Barmherzige Bruder Regensburg
  • Marienhospital
  • Robert-Bosch-Krankenhaus
  • Universitätsklinikum Tübingen
  • Universtitätsklinikum Ulm; Klinik für Innere Medizin III
  • Medizinisches Versorgungszentrum Nuklearmedizin-Strahlentherapie-Onkologie
  • Arcispedale S. Anna; Sezione Di Ematologia
  • Ospedali Riuniti Papardo-Piemonte; Struttura Complessa Di Ematologia
  • Uni Cattolica; Divisione Di Ematologia
  • AOU Città della Salute e della Scienza di Torino - Presidio Le Molinette
  • Ospedale San Raffaele
  • Az. Osp. S. Maria; Dept. Di Oncologia Medica
  • Ospedale dell' Angelo; U.O. Ematologia
  • Hospital General de Culiacan
  • Canterbury Health Laboratories; Haematology
  • Dunedin Hospital
  • Midcentral District Health Board
  • Wellington Hospital
  • Uniwersytecki Szpital Kliniczny w Bia?ymstoku, Klinika Hematologii z Pododdzia?em Chorob Naczyn
  • Samodzielny Public Zaklad
  • Wojewódzki Szpital Specjalistyczny im.Miko?ajaKopernika;KlinikaHematologiiUniwersytetuMedycznego
  • Wojewodzki Szpital Specjalistyczny im. J. Korczaka; Oddzia? Chorób Wewnetrznych/Hematologiczny
  • Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroc?awiu; Klinika Hematologii
  • Fundeni Clinical Inst. ; Hematology Dept
  • Institutul Regional de Oncologie Iasi; Clinica de Hematologie
  • Spitalul Clinic Judetean de Urgenta Targu-Mures; compartiment Hematologie
  • SBEI of HPE ?Bashkir State Medical University? of MoH RF
  • Moscow State Budgetary Healthcare Institution
  • Regional Clinical Hospital N.A. Semashko; Hematology
  • Rostov State Medical Uni ; Hematology
  • Republican Clinical Oncologic Dispensary of Republic Of Tatarstan
  • Penza Regional Oncology Dispensary
  • Clinical MSCh No1
  • Complejo Hospitalario de Navarra
  • Hospital Universitario de Canarias;servicio de Hematologia
  • Hospital del Mar; Servicio de Hematologia
  • Hospital Universitari Vall d'Hebron; Servicio de Hematologia
  • Hospital Clínic i Provincial; Servicio de Hematología y Oncología
  • Hospital Universitario de la Princesa; Servicio de Hematologia
  • Hospital Universitario La Paz
  • Hospital Universitario Ramón y Cajal
  • Hospital Univ. 12 de Octubre; Servicio de Hematologia
  • Hospital Clinico Universitario de Salamanca;Servicio de Hematologia
  • Hospital Universitario Virgen del Rocio
  • Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Hematología
  • Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
  • Hospital Arnau de Vilanova (Valencia) Servicio de Hematologia
  • Inselspital Bern; Hämatologie und Hämatologisches Zentrallabor
  • Luzerner Kantonsspital, Hämatologie
  • Universitätsspital Zürich Medizin Hämatologie; Klinik für Hämatologie
  • Birmingham Heartlands Hospital
  • Boston Pilgrim Hospital
  • Western General Hospital; Department of Haematology
  • Lincoln County Hospital
  • University Hospital Southampton NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Safety Run-in Obinutuzumab + Venetoclax

Obinutuzumab + Chlorambucil

Obinutuzumab + Venetoclax

Arm Description

Subjects received obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles comprised of 28 days.

Participants will receive obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles will comprise 28 days.

Participants will receive obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles will comprise 28 days.

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS) Based on Investigator Assessment According to IWCLL Criteria
PFS was determined according to IWCLL 2008 criteria and defined as the time from randomization to the first occurrence of PD or death from any cause. Disease progression was characterized by at least one of the following: 1) >/= 50% increase in the absolute number of circulating lymphocytes to at least 5*10^9/L, 2) Appearance of new palpable lymph nodes (> 15 mm in longest diameter) or any new extra-nodal lesion; 3) >/= 50% increase in the longest diameter of any previous site of lymphadenopathy; 4) >/= 50% increase in the enlargement of the liver and/or spleen; 5) Transformation to a more aggressive histology.

Secondary Outcome Measures

Progression Free Survival (PFS) Based on Institutional Review Committee (IRC)-Assessments According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria
PFS was determined according to IWCLL 2008 criteria and defined as the time from randomization to the first occurrence of progressive disease (PD) or death from any cause. Disease progression was characterized by at least one of the following: 1) >/= 50% increase in the absolute number of circulating lymphocytes to at least 5*10^9/L, 2) Appearance of new palpable lymph nodes (> 15 mm in longest diameter) or any new extra-nodal lesion; 3) >/= 50% increase in the longest diameter of any previous site of lymphadenopathy; 4) >/= 50% increase in the enlargement of the liver and/or spleen; 5) Transformation to a more aggressive histology.
Percentage of Participants With an Overall Response (OR) at Completion of Treatment, as Determined by the Investigator According to IWCLL Criteria
OR was defined as complete response (CR), CR with incomplete bone marrow recovery (CRi), or partial response (PR) according to IWCLL 2008 criteria. CR requires all of the following: peripheral blood lymphocytes below 4x10^9/L, absence of lymphadenopathy by physical examination and computed tomography (CT) scan, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils >1.5*10^9/L, platelets >100*10^9/L and hemoglobin >110 g/L, bone marrow at least normocellular for age without clonal infiltrate (except for Cri). PR: two of the following features for at least 2 months: >/= 50% decrease in peripheral blood lymphocyte count from the pretreatment value, >/=50% reduction in lymphadenopathy, >/=50% reduction of liver and/or spleen enlargement, and at least one of the following blood counts: neutrophils >1.5*10^9/L, platelets >100*10^9/L and hemoglobin >110 g/L.
Percentage of Participants With a Complete Response Rate (CRR) at the Completion of Treatment Assessment as Determined by the Investigator According to IWCLL Criteria
CRR was defined as the rate of a clinical response of CR or CRi according to IWCLL 2008 criteria. CR requires all of the following: peripheral blood lymphocytes below 4x10^9/L, absence of lymphadenopathy by physical examination and CT scan, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils >1.5*10^9/L, platelets >100*10^9/L and hemoglobin >110 g/L, bone marrow at least normocellular for age without clonal infiltrate (except for Cri).
Percentage of Participants With Minimal Residual Disease (MRD) Negativity in Peripheral Blood as Measured by Allele-Specific Oligonucleotide Polymerase Chain Reaction (ASO-PCR) at Completion of Treatment
MRD negativity was defined as having < 1 CLL cell per 10,000 leucocytes in peripheral blood.
Percentage of Participants With MRD Negativity in Bone Marrow as Measured by ASO-PCR at Completion of Treatment
MRD negativity was defined as having < 1 CLL cell per 10,000 leucocytes in bone marrow.
Overall Survival (OS)
OS was defined as the time between the date of randomization and the date of death due to any cause.
Percentage of Participants With MRD Negativity in Peripheral Blood as Measured by ASO-PCR at Completion of Combination Treatment Assessment
MRD negativity was defined as having < 1 CLL cell per 10,000 leucocytes in peripheral blood.
Percentage of Participants With MRD Negativity in Bone Marrow as Measured by ASO-PCR at Completion of Combination Treatment Assessment
MRD negativity was defined as having < 1 CLL cell per 10,000 leucocytes in bone marrow.
Percentage of Participants With OR at Completion of Combination Treatment Response Assessment
OR was defined as CR, CRi or PR according to IWCLL 2008 criteria. CR required all of the following: peripheral blood lymphocytes below 4x10^9/L, absence of lymphadenopathy by physical examination, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils >1.5*10^9/L, platelets >100*10^9/L and hemoglobin >110 g/L. PR: two of the following features for at least 2 months: >/= 50% decrease in peripheral blood lymphocyte count from the pretreatment value, >/=50% reduction in lymphadenopathy, >/=50% reduction of liver and/or spleen enlargement, and at least one of the following blood counts: neutrophils >1.5*10^9/L, platelets >100*10^9/L and hemoglobin >110 g/L.
Duration of Objective Response (DOR)
PD was defined as lymphadenopathy, >=50% increase in liver or spleen size, >=50% increase in lymphocyte count, transformation to a more aggressive histology or occurrence of cytopenia.
Percentage of Participants By Best Response Achieved (CR, CRi, PR, Stable Disease (SD), or PD)
CR: peripheral blood lymphocytes below 4x10^9/L, absence of lymphadenopathy by physical examination and CT scan, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils >1.5*10^9/L, platelets >100*10^9/L and hemoglobin >110 g/L, bone marrow at least normocellular for age without clonal infiltrate (except for Cri). PR: any two for at least 2 months: >/= 50% decrease in peripheral blood lymphocyte count from the pretreatment value, >/=50% reduction in lymphadenopathy, >/=50% reduction of liver and/or spleen enlargement, and at least one of the following blood counts: neutrophils >1.5*10^9/L, platelets >100*10^9/L and hemoglobin >110 g/L. PD: lymphadenopathy, >=50% increase in liver or spleen size, >=50% increase in lymphocyte count, transformation to a more aggressive histology or occurrence of cytopenia. SD: a non-response and used to characterize participants who did not achieve a CR or a PR, and who have not exhibited PD.
Event-Free Survival
Time to Next Anti-Leukemic Treatment
Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs.
Percentage of Participants With CD19 + /CD5+ B Cells or CD14+ Monocytes
Percentage of Participants With Human-Anti-Human Antibodies
Percentage of Participants Recorded as Premature Study Withdrawals
Plasma Concentrations of Venetoclax
Serum Concentrations of Obinutuzumab
Change From Baseline in M.D. Anderson Symptom Inventory-CLL (MDASI-CLL) Score
The MDASI-CLL is a questionnaire of 25 items related to CLL specific symptoms that a participant may have experienced in the past 24 hours. Participants were asked to rate the severity of 13 symptoms called mean core symptom severity (i.e., pain, fatigue, nausea, disturbed sleep, distressed, shortness of breath, remembering things, lack of appetite, drowsy, dry mouth, sadness, vomiting, and numbness or tingling), 6 disease-specific symptoms called mean module symptom severity (night sweats, fevers and chills, lymph node swelling, diarrhea, easy bruising or bleeding, and constipation) and 6 mean interference on life questions (i.e., general activity, walking, work, mood, relations with other people, and enjoyment of life) on a scale from 0 to 10 with 0 indicating that the symptom is "not present" or "did not interfere" with the participant's activities and 10 indicating "as bad as you can imagine" or "interfered completely". Scores were averaged (range 0 to 10) for each of three parts.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQC30)
The EORTC QLQ-C30 is a validated and reliable self-report measure consisting of 30 questions incorporated into five functional scales (physical, role, cognitive, emotional, and social scales), three symptom scales (fatigue, pain, nausea, and vomiting scales), and a global health status/global quality-of-life scale. The remaining single items (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) assess the additional symptoms experienced by patients with cancer and the perceived financial burden of treatment. The 28 function and symptom items were scored on a 4-point scale that ranged from "not at all" to "very much," and the 2 global health status/global quality-of-life items were scored on a 7-point scale that ranged from "very poor" to "excellent." Raw average scale scores were linearly transformed to range 0-100 with higher scores indicating higher response levels (i.e., higher functioning, higher symptom severity).
Change From Baseline in EuroQol 5 Dimension Questionnaire (EQ-5D-3L)
The EQ-5D-3L questionnaire is a generic, preference based health utility measure that assesses 5 health states (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and is used to build a composite of the patient's health status. The EQ-5D-3L was employed in this study to calculate health utilities for economic modeling, which ranged 0-1. The EQ-5D-3L also contained a visual analog scale (VAS) to assess the participant's overall health, which ranged from 0-100 with a higher score indicating a worse health status.

Full Information

First Posted
September 16, 2014
Last Updated
September 15, 2023
Sponsor
Hoffmann-La Roche
Collaborators
AbbVie, German CLL Study Group
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1. Study Identification

Unique Protocol Identification Number
NCT02242942
Brief Title
Comparison of the Treatments of Obinutuzumab + Venetoclax Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia
Official Title
A Prospective, Open-Label, Multicenter Randomized Phase III Trial to Compare The Efficacy and Safety of A Combined Regimen of Obinutuzumab and Venetoclax Versus Obinutuzumab and Chlorambucil in Previously Untreated Patients With CLL and Coexisting Medical Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 31, 2014 (Actual)
Primary Completion Date
August 17, 2018 (Actual)
Study Completion Date
August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
Collaborators
AbbVie, German CLL Study Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This open-label, multicenter, randomized Phase III study is designed to compare the efficacy and safety of a combined regimen of obinutuzumab and venetoclax versus obinutuzumab + chlorambucil in participants with chronic lymphocytic leukemia (CLL) and coexisting medical conditions. The time on study treatment was approximately one year and the follow-up period will be up to 9 years.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
445 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Safety Run-in Obinutuzumab + Venetoclax
Arm Type
Experimental
Arm Description
Subjects received obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles comprised of 28 days.
Arm Title
Obinutuzumab + Chlorambucil
Arm Type
Experimental
Arm Description
Participants will receive obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles will comprise 28 days.
Arm Title
Obinutuzumab + Venetoclax
Arm Type
Experimental
Arm Description
Participants will receive obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles will comprise 28 days.
Intervention Type
Drug
Intervention Name(s)
Chlorambucil
Intervention Description
Chlorambucil 0.5 milligrams per kilogram (mg/kg) orally at Day 1 and Day 15 at of each 28 day cycle for 12 cycles.
Intervention Type
Drug
Intervention Name(s)
Venetoclax
Other Intervention Name(s)
ABT-0199, GDC-0199
Intervention Description
Venetoclax, oral tablet: 20 mg daily during Cycle 1, Day 22-28; 50 mg daily during Cycle 2, Day 1-7; 100 mg daily during Cycle 2, Day 8-14; 200 mg daily during Cycle 2, Day 15-21; 400 mg daily during Cycle 2, Day 22-28 and on Day 1-28 for all subsequent cycles until the end of Cycle 12.
Intervention Type
Drug
Intervention Name(s)
Obinutuzumab
Other Intervention Name(s)
GA-101; Gazyva
Intervention Description
Obinutuzumab, IV infusion: 100 mg or 1000 mg, depending on splitting rules, at Cycle 1, Day 1 (if 100 mg was received on Day 1, 900 mg will be administered on Cycle 1, Day 2); 1000 mg at Cycle 1, Day 8 and Day 15; 1000 mg at Day 1 for all subsequent cycles until the end of Cycle 6
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS) Based on Investigator Assessment According to IWCLL Criteria
Description
PFS was determined according to IWCLL 2008 criteria and defined as the time from randomization to the first occurrence of PD or death from any cause. Disease progression was characterized by at least one of the following: 1) >/= 50% increase in the absolute number of circulating lymphocytes to at least 5*10^9/L, 2) Appearance of new palpable lymph nodes (> 15 mm in longest diameter) or any new extra-nodal lesion; 3) >/= 50% increase in the longest diameter of any previous site of lymphadenopathy; 4) >/= 50% increase in the enlargement of the liver and/or spleen; 5) Transformation to a more aggressive histology.
Time Frame
Baseline until disease progression or death up to approximately 3.75 years
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS) Based on Institutional Review Committee (IRC)-Assessments According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria
Description
PFS was determined according to IWCLL 2008 criteria and defined as the time from randomization to the first occurrence of progressive disease (PD) or death from any cause. Disease progression was characterized by at least one of the following: 1) >/= 50% increase in the absolute number of circulating lymphocytes to at least 5*10^9/L, 2) Appearance of new palpable lymph nodes (> 15 mm in longest diameter) or any new extra-nodal lesion; 3) >/= 50% increase in the longest diameter of any previous site of lymphadenopathy; 4) >/= 50% increase in the enlargement of the liver and/or spleen; 5) Transformation to a more aggressive histology.
Time Frame
Baseline until disease progression or death up to approximately 3.75 years
Title
Percentage of Participants With an Overall Response (OR) at Completion of Treatment, as Determined by the Investigator According to IWCLL Criteria
Description
OR was defined as complete response (CR), CR with incomplete bone marrow recovery (CRi), or partial response (PR) according to IWCLL 2008 criteria. CR requires all of the following: peripheral blood lymphocytes below 4x10^9/L, absence of lymphadenopathy by physical examination and computed tomography (CT) scan, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils >1.5*10^9/L, platelets >100*10^9/L and hemoglobin >110 g/L, bone marrow at least normocellular for age without clonal infiltrate (except for Cri). PR: two of the following features for at least 2 months: >/= 50% decrease in peripheral blood lymphocyte count from the pretreatment value, >/=50% reduction in lymphadenopathy, >/=50% reduction of liver and/or spleen enlargement, and at least one of the following blood counts: neutrophils >1.5*10^9/L, platelets >100*10^9/L and hemoglobin >110 g/L.
Time Frame
At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months)
Title
Percentage of Participants With a Complete Response Rate (CRR) at the Completion of Treatment Assessment as Determined by the Investigator According to IWCLL Criteria
Description
CRR was defined as the rate of a clinical response of CR or CRi according to IWCLL 2008 criteria. CR requires all of the following: peripheral blood lymphocytes below 4x10^9/L, absence of lymphadenopathy by physical examination and CT scan, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils >1.5*10^9/L, platelets >100*10^9/L and hemoglobin >110 g/L, bone marrow at least normocellular for age without clonal infiltrate (except for Cri).
Time Frame
At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months)
Title
Percentage of Participants With Minimal Residual Disease (MRD) Negativity in Peripheral Blood as Measured by Allele-Specific Oligonucleotide Polymerase Chain Reaction (ASO-PCR) at Completion of Treatment
Description
MRD negativity was defined as having < 1 CLL cell per 10,000 leucocytes in peripheral blood.
Time Frame
At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months)
Title
Percentage of Participants With MRD Negativity in Bone Marrow as Measured by ASO-PCR at Completion of Treatment
Description
MRD negativity was defined as having < 1 CLL cell per 10,000 leucocytes in bone marrow.
Time Frame
At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months)
Title
Overall Survival (OS)
Description
OS was defined as the time between the date of randomization and the date of death due to any cause.
Time Frame
Baseline until death, up to approximately 10.75 years
Title
Percentage of Participants With MRD Negativity in Peripheral Blood as Measured by ASO-PCR at Completion of Combination Treatment Assessment
Description
MRD negativity was defined as having < 1 CLL cell per 10,000 leucocytes in peripheral blood.
Time Frame
Day 1 Cycle 9 or 3 months after last IV infusion, approximately 9 months
Title
Percentage of Participants With MRD Negativity in Bone Marrow as Measured by ASO-PCR at Completion of Combination Treatment Assessment
Description
MRD negativity was defined as having < 1 CLL cell per 10,000 leucocytes in bone marrow.
Time Frame
Day 1 Cycle 9 or 3 months after last IV infusion at approximately 9 months
Title
Percentage of Participants With OR at Completion of Combination Treatment Response Assessment
Description
OR was defined as CR, CRi or PR according to IWCLL 2008 criteria. CR required all of the following: peripheral blood lymphocytes below 4x10^9/L, absence of lymphadenopathy by physical examination, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils >1.5*10^9/L, platelets >100*10^9/L and hemoglobin >110 g/L. PR: two of the following features for at least 2 months: >/= 50% decrease in peripheral blood lymphocyte count from the pretreatment value, >/=50% reduction in lymphadenopathy, >/=50% reduction of liver and/or spleen enlargement, and at least one of the following blood counts: neutrophils >1.5*10^9/L, platelets >100*10^9/L and hemoglobin >110 g/L.
Time Frame
Day 1 Cycle 7 or 28 days after last IV infusion, approximately 6 months
Title
Duration of Objective Response (DOR)
Description
PD was defined as lymphadenopathy, >=50% increase in liver or spleen size, >=50% increase in lymphocyte count, transformation to a more aggressive histology or occurrence of cytopenia.
Time Frame
Time from the first occurrence of a documented objective response to the time of PD as determined by the investigator or death from any cause, up to approximately 10.75 years
Title
Percentage of Participants By Best Response Achieved (CR, CRi, PR, Stable Disease (SD), or PD)
Description
CR: peripheral blood lymphocytes below 4x10^9/L, absence of lymphadenopathy by physical examination and CT scan, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils >1.5*10^9/L, platelets >100*10^9/L and hemoglobin >110 g/L, bone marrow at least normocellular for age without clonal infiltrate (except for Cri). PR: any two for at least 2 months: >/= 50% decrease in peripheral blood lymphocyte count from the pretreatment value, >/=50% reduction in lymphadenopathy, >/=50% reduction of liver and/or spleen enlargement, and at least one of the following blood counts: neutrophils >1.5*10^9/L, platelets >100*10^9/L and hemoglobin >110 g/L. PD: lymphadenopathy, >=50% increase in liver or spleen size, >=50% increase in lymphocyte count, transformation to a more aggressive histology or occurrence of cytopenia. SD: a non-response and used to characterize participants who did not achieve a CR or a PR, and who have not exhibited PD.
Time Frame
Baseline up to the completion of treatment assessment 3 months after treatment completion (up to approximately 15 months)
Title
Event-Free Survival
Time Frame
Time between date of randomization and the date of disease progression/relapse on the basis of investigator-assessment, death, or start of a new anti-leukemic therapy, up to 10.75 years
Title
Time to Next Anti-Leukemic Treatment
Time Frame
Time between the date of randomization and the date of first intake of new anti-leukemic therapy, up to 10.75 years
Title
Number of Participants With Adverse Events (AEs)
Description
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs.
Time Frame
Up to approximately 10.75 years
Title
Percentage of Participants With CD19 + /CD5+ B Cells or CD14+ Monocytes
Time Frame
Baseline up to approximately 10.75 years
Title
Percentage of Participants With Human-Anti-Human Antibodies
Time Frame
Baseline up to approximately 10.75 years
Title
Percentage of Participants Recorded as Premature Study Withdrawals
Time Frame
Up to approximately 10.75 years
Title
Plasma Concentrations of Venetoclax
Time Frame
Pre-venetoclax dose (0 hour) and 4 hours post- venetoclax dose on Day 1 Cycle 4
Title
Serum Concentrations of Obinutuzumab
Time Frame
Pre-obinutuzumab infusion (0 hour) and end of obinutuzumab infusion on Day 1 Cycle 4
Title
Change From Baseline in M.D. Anderson Symptom Inventory-CLL (MDASI-CLL) Score
Description
The MDASI-CLL is a questionnaire of 25 items related to CLL specific symptoms that a participant may have experienced in the past 24 hours. Participants were asked to rate the severity of 13 symptoms called mean core symptom severity (i.e., pain, fatigue, nausea, disturbed sleep, distressed, shortness of breath, remembering things, lack of appetite, drowsy, dry mouth, sadness, vomiting, and numbness or tingling), 6 disease-specific symptoms called mean module symptom severity (night sweats, fevers and chills, lymph node swelling, diarrhea, easy bruising or bleeding, and constipation) and 6 mean interference on life questions (i.e., general activity, walking, work, mood, relations with other people, and enjoyment of life) on a scale from 0 to 10 with 0 indicating that the symptom is "not present" or "did not interfere" with the participant's activities and 10 indicating "as bad as you can imagine" or "interfered completely". Scores were averaged (range 0 to 10) for each of three parts.
Time Frame
Baseline up to approximately 10.75 years
Title
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQC30)
Description
The EORTC QLQ-C30 is a validated and reliable self-report measure consisting of 30 questions incorporated into five functional scales (physical, role, cognitive, emotional, and social scales), three symptom scales (fatigue, pain, nausea, and vomiting scales), and a global health status/global quality-of-life scale. The remaining single items (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) assess the additional symptoms experienced by patients with cancer and the perceived financial burden of treatment. The 28 function and symptom items were scored on a 4-point scale that ranged from "not at all" to "very much," and the 2 global health status/global quality-of-life items were scored on a 7-point scale that ranged from "very poor" to "excellent." Raw average scale scores were linearly transformed to range 0-100 with higher scores indicating higher response levels (i.e., higher functioning, higher symptom severity).
Time Frame
Baseline up to approximately 10.75 years
Title
Change From Baseline in EuroQol 5 Dimension Questionnaire (EQ-5D-3L)
Description
The EQ-5D-3L questionnaire is a generic, preference based health utility measure that assesses 5 health states (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and is used to build a composite of the patient's health status. The EQ-5D-3L was employed in this study to calculate health utilities for economic modeling, which ranged 0-1. The EQ-5D-3L also contained a visual analog scale (VAS) to assess the participant's overall health, which ranged from 0-100 with a higher score indicating a worse health status.
Time Frame
Baseline up to approximately 10.75 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Documented previously untreated CLL according to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria CLL requiring treatment according to IWCLL criteria Total Cumulative Illness Rating Scale (CIRS score) greater than (>) 6 Adequate marrow function independent of growth factor or transfusion support within 2 weeks of screening as per protocol, unless cytopenia is due to marrow involvement of CLL Adequate liver function Life expectancy > 6 months Agreement to use highly effective contraceptive methods per protocol Exclusion Criteria: Transformation of CLL to aggressive Non-Hodgkin's lymphoma (Richter's transformation or pro-lymphocytic leukemia) Known central nervous system involvement Participants with a history of confirmed progressive multifocal leukoencephalopathy (PML) An individual organ/ system impairment score of 4 as assessed by the CIRS definition limiting the ability to receive the treatment regimen of this trial with the exception of eyes, ears, nose, throat organ system Participants with uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia Inadequate renal function History of prior malignancy, except for conditions as listed in the protocol if participants have recovered from the acute side effects incurred as a result of previous therapy Use of investigational agents or concurrent anti-cancer treatment within the last 4 weeks of registration Participants with active bacterial, viral, or fungal infection requiring systemic treatment within the last two months prior to registration History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products Hypersensitivity to chlorambucil, obinutuzumab, or venetoclax or to any of the excipients Pregnant women and nursing mothers Positive test results for chronic hepatitis B virus (HBV) infection (defined as positive hepatitis B surface antigen [HBsAg] serology) or positive test result for hepatitis C (hepatitis C virus [HCV] antibody serology testing) Participants with known infection with human immunodeficiency virus (HIV) or human T-cell leukemia virus-1 (HTLV-1) Requires the use of warfarin, marcumar, or phenprocoumon Received agents known to be strong and moderate Cytochrome P450 3A inhibitors or inducers within 7 days prior to the first dose of study drug
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
San Diego Pacific Hematology Assocates
City
Encinitas
State/Province
California
ZIP/Postal Code
92024-1375
Country
United States
Facility Name
UC San Diego Health System
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Banner MD Anderson Cancer Center
City
Greeley
State/Province
Colorado
ZIP/Postal Code
85234
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Ingalls Memorial Hospital
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Joe Arrington Cancer Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
Hospital Italiano
City
Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Tweed Hospital
City
Tweed Heads
State/Province
New South Wales
ZIP/Postal Code
2485
Country
Australia
Facility Name
The Townsville Hospital
City
Douglas
State/Province
Queensland
ZIP/Postal Code
4814
Country
Australia
Facility Name
Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Royal Adelaide Hospital; Haematology Clinical Trials
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Ashford Cancer Centre Research; Internal Medicine/Medical Oncology
City
Ashford
State/Province
South Australia
ZIP/Postal Code
5035
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
The Northern Hospital
City
Epping
State/Province
Victoria
ZIP/Postal Code
VIC 3076
Country
Australia
Facility Name
Monash Medical Centre; Haematology
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Hämatologie & Hämostaseologie
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Hanusch-Krankenhaus; Iii. Medizinische Abt.
City
Wien
ZIP/Postal Code
1140
Country
Austria
Facility Name
Wilhelminenspital; I. Medizinische Abt.
City
Wien
ZIP/Postal Code
1160
Country
Austria
Facility Name
Hospital das Clinicas - UFRGS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Instituto de Ensino e Pesquisa Sao Lucas - IEP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01236-030
Country
Brazil
Facility Name
Hospital Sírio-Libanês
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01308-050
Country
Brazil
Facility Name
Hospital das Clinicas - FMUSP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-010
Country
Brazil
Facility Name
Hospital Santa Marcelina
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
08270-070
Country
Brazil
Facility Name
UMHAT Dr Georgi Stranski; Hematology
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
UMHAT " Sveti Georgi" Plovdiv - Clinic of Oncology and Hematology
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
University Hospital Sv.Georgi Clnic of Hematology; Hematology
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
University Multiprofile Hospital For Active Treatment "Sveti Ivan Rilski" EAD; clinical hematology
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
MHAT Hristo Botev; First Internal Department
City
Vratsa
ZIP/Postal Code
3000
Country
Bulgaria
Facility Name
Tom Baker Cancer Centre; Dept of Medicine
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Centre; Oncology
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
University Hospital Center Zagreb; Haematology Department
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
University Hospital Merkur Clinic for Internal Medicine/ Hematology
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Herlev Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Rigshospitalet
City
København Ø
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Sjællands Universitetshospital, Roskilde
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Sygehus Lillebælt, Vejle
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Facility Name
North Estonia medical Centre; Hematology
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Tartu Uni Hospital; Hematology - Oncology Clinic
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
CHU Besançon - Hôpital Jean Minjoz
City
Besançon Cedex
ZIP/Postal Code
25030
Country
France
Facility Name
Institut d'Hématologie de Basse Normandie
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
Chu Estaing; Hematologie Clinique Adultes
City
Clermont Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Hopital Henri Mondor
City
Creteil
ZIP/Postal Code
94000
Country
France
Facility Name
CHU de Dijon - Hopital le Bocage
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
CHU de Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Centre Jean Bernard
City
Le Mans
ZIP/Postal Code
72015
Country
France
Facility Name
Centre Leon Berard; Departement Oncologie Medicale
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Hôpital Saint Eloi; Service d?Hématologie et Oncologie Clinique - Recherche Clinique
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Hopital Hotel Dieu Et Hme;Hopital De Jour
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset)
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Hopital Pontchaillou; Hematologie Clinique
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Centre Henri Becquerel; Hematologie
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
CH de Toulon Hôpital Sainte Musse
City
Toulon
ZIP/Postal Code
83056
Country
France
Facility Name
Institut Gustave Roussy - Hematologie
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Uniklinik RWTH Aachen; Klinik IV; Klinik Hämatologie, Onkologie, Hämostaseologie und Stamm.
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Gesundheitszentrum St. Marien GmbH; Med. II, Hämatologie/Onkologie
City
Amberg
ZIP/Postal Code
92224
Country
Germany
Facility Name
Charite - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Charite - Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik und Poliklinik I
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum Essen; Klinik für Hämatologie
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Klinik Esslingen; Klinik für Allgemeine Innere Medizin, Onkologie/Haematologie
City
Esslingen
ZIP/Postal Code
73730
Country
Germany
Facility Name
Klinikum Frankfurt/Oder
City
Frankfurt/Oder
ZIP/Postal Code
15236
Country
Germany
Facility Name
Uniklinikum Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Uni Göttingen, Georg-August-Universität; Klinik für Hämatologie und Medizinische Onkologie
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Universitaetsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Stiftung Kathol. Krankenhaus Marienhospital Herne Klinik Mitte
City
Herne
ZIP/Postal Code
44625
Country
Germany
Facility Name
Praxisklinik für Hämatologie und Onkologie Koblenz
City
Koblenz
ZIP/Postal Code
56068
Country
Germany
Facility Name
Universitätsklinikum Köln; Innere Medizin I; Onkologie, Hämatologie
City
Köln
ZIP/Postal Code
50931
Country
Germany
Facility Name
Tagesklinik Landshut; Hämatologie/Onkologie
City
Landshut
ZIP/Postal Code
84028
Country
Germany
Facility Name
Klinikum rechts der Isar der Technischen Universität München
City
Munchen
ZIP/Postal Code
81675
Country
Germany
Facility Name
Klinikum Schwäbisch Gmünd
City
Mutlangen
ZIP/Postal Code
73557
Country
Germany
Facility Name
Kliniken Maria Hilf GmbH; Innere Medizin I; Hämatologie und internistische Onkologie
City
Mönchengladbach
ZIP/Postal Code
41063
Country
Germany
Facility Name
München Klinik Schwabing; Klinik für Hämatologie, Onkologie, Immunologie
City
München
ZIP/Postal Code
80804
Country
Germany
Facility Name
Klinikum der Universität München, Campus Großhadern; Medizinische Klinik und Poliklinik III
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Gemeinschaftspraxis Dr. med. Holger Klaproth
City
Neunkirchen/Saar
ZIP/Postal Code
66538
Country
Germany
Facility Name
Brüderkrankenhaus St. Josef Paderborn
City
Paderborn
ZIP/Postal Code
33098
Country
Germany
Facility Name
Krankenhaus Barmherzige Bruder Regensburg
City
Regensburg
ZIP/Postal Code
93049
Country
Germany
Facility Name
Marienhospital
City
Stuttgart
ZIP/Postal Code
70199
Country
Germany
Facility Name
Robert-Bosch-Krankenhaus
City
Stuttgart
ZIP/Postal Code
70376
Country
Germany
Facility Name
Universitätsklinikum Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universtitätsklinikum Ulm; Klinik für Innere Medizin III
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Medizinisches Versorgungszentrum Nuklearmedizin-Strahlentherapie-Onkologie
City
Weiden
ZIP/Postal Code
92367
Country
Germany
Facility Name
Arcispedale S. Anna; Sezione Di Ematologia
City
Ferrara
State/Province
Emilia-Romagna
ZIP/Postal Code
44100
Country
Italy
Facility Name
Ospedali Riuniti Papardo-Piemonte; Struttura Complessa Di Ematologia
City
Messina
State/Province
Lazio
ZIP/Postal Code
98158
Country
Italy
Facility Name
Uni Cattolica; Divisione Di Ematologia
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
AOU Città della Salute e della Scienza di Torino - Presidio Le Molinette
City
Torino
State/Province
Lazio
ZIP/Postal Code
10126
Country
Italy
Facility Name
Ospedale San Raffaele
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Facility Name
Az. Osp. S. Maria; Dept. Di Oncologia Medica
City
Terni
State/Province
Umbria
ZIP/Postal Code
05100
Country
Italy
Facility Name
Ospedale dell' Angelo; U.O. Ematologia
City
Venezia Mestre
State/Province
Veneto
ZIP/Postal Code
30174
Country
Italy
Facility Name
Hospital General de Culiacan
City
Culiacan
State/Province
Sinaloa
ZIP/Postal Code
80230
Country
Mexico
Facility Name
Canterbury Health Laboratories; Haematology
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Dunedin Hospital
City
Dunedin
Country
New Zealand
Facility Name
Midcentral District Health Board
City
Palmerston North
ZIP/Postal Code
4442
Country
New Zealand
Facility Name
Wellington Hospital
City
Wellington
ZIP/Postal Code
6012
Country
New Zealand
Facility Name
Uniwersytecki Szpital Kliniczny w Bia?ymstoku, Klinika Hematologii z Pododdzia?em Chorob Naczyn
City
Bialystok
ZIP/Postal Code
15-2
Country
Poland
Facility Name
Samodzielny Public Zaklad
City
Chorzów
ZIP/Postal Code
41-500
Country
Poland
Facility Name
Wojewódzki Szpital Specjalistyczny im.Miko?ajaKopernika;KlinikaHematologiiUniwersytetuMedycznego
City
Lodz
ZIP/Postal Code
9351
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny im. J. Korczaka; Oddzia? Chorób Wewnetrznych/Hematologiczny
City
Slupsk
ZIP/Postal Code
76-200
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroc?awiu; Klinika Hematologii
City
Wroclaw
ZIP/Postal Code
5036
Country
Poland
Facility Name
Fundeni Clinical Inst. ; Hematology Dept
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Institutul Regional de Oncologie Iasi; Clinica de Hematologie
City
Iasi
ZIP/Postal Code
700483
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Targu-Mures; compartiment Hematologie
City
Targu-mures
ZIP/Postal Code
540136
Country
Romania
Facility Name
SBEI of HPE ?Bashkir State Medical University? of MoH RF
City
UFA
State/Province
Baskortostan
ZIP/Postal Code
450000
Country
Russian Federation
Facility Name
Moscow State Budgetary Healthcare Institution
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
123182
Country
Russian Federation
Facility Name
Regional Clinical Hospital N.A. Semashko; Hematology
City
Nizhny Novgorod
State/Province
Niznij Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
Rostov State Medical Uni ; Hematology
City
Rostov-na-donu
State/Province
Rostov
ZIP/Postal Code
344022
Country
Russian Federation
Facility Name
Republican Clinical Oncologic Dispensary of Republic Of Tatarstan
City
Kazan
State/Province
Tatarstan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Penza Regional Oncology Dispensary
City
Penza
ZIP/Postal Code
440071
Country
Russian Federation
Facility Name
Clinical MSCh No1
City
Perm
ZIP/Postal Code
614077
Country
Russian Federation
Facility Name
Complejo Hospitalario de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitario de Canarias;servicio de Hematologia
City
La Laguna
State/Province
Tenerife
ZIP/Postal Code
38320
Country
Spain
Facility Name
Hospital del Mar; Servicio de Hematologia
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron; Servicio de Hematologia
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
City
Barcelona
ZIP/Postal Code
08036
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
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Univ. 12 de Octubre; Servicio de Hematologia
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Clinico Universitario de Salamanca;Servicio de Hematologia
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Hematología
City
Toledo
ZIP/Postal Code
45004
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Arnau de Vilanova (Valencia) Servicio de Hematologia
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Facility Name
Inselspital Bern; Hämatologie und Hämatologisches Zentrallabor
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Luzerner Kantonsspital, Hämatologie
City
Luzern
ZIP/Postal Code
6000
Country
Switzerland
Facility Name
Universitätsspital Zürich Medizin Hämatologie; Klinik für Hämatologie
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Boston Pilgrim Hospital
City
Boston,Lincolnshire
ZIP/Postal Code
PE21 9QS
Country
United Kingdom
Facility Name
Western General Hospital; Department of Haematology
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Lincoln County Hospital
City
Lincoln
ZIP/Postal Code
LN2 5QY
Country
United Kingdom
Facility Name
University Hospital Southampton NHS Foundation Trust
City
Southhampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
35829925
Citation
Badawi M, Chen X, Marroum P, Suleiman AA, Mensing S, Koenigsdorfer A, Schiele JT, Palenski T, Samineni D, Hoffman D, Menon R, Salem AH. Bioavailability Evaluation of Venetoclax Lower-Strength Tablets and Oral Powder Formulations to Establish Interchangeability with the 100 mg Tablet. Clin Drug Investig. 2022 Aug;42(8):657-668. doi: 10.1007/s40261-022-01172-4. Epub 2022 Jul 13.
Results Reference
derived
PubMed Identifier
35708885
Citation
Samineni D, Gibiansky L, Wang B, Vadhavkar S, Rajwanshi R, Tandon M, Sinha A, Al-Sawaf O, Fischer K, Hallek M, Salem AH, Li C, Miles D. Pharmacokinetics and Exposure-Response Analysis of Venetoclax + Obinutuzumab in Chronic Lymphocytic Leukemia: Phase 1b Study and Phase 3 CLL14 Trial. Adv Ther. 2022 Aug;39(8):3635-3653. doi: 10.1007/s12325-022-02170-w. Epub 2022 Jun 16.
Results Reference
derived
PubMed Identifier
34709929
Citation
Al-Sawaf O, Zhang C, Lu T, Liao MZ, Panchal A, Robrecht S, Ching T, Tandon M, Fink AM, Tausch E, Schneider C, Ritgen M, Bottcher S, Kreuzer KA, Chyla B, Miles D, Wendtner CM, Eichhorst B, Stilgenbauer S, Jiang Y, Hallek M, Fischer K. Minimal Residual Disease Dynamics after Venetoclax-Obinutuzumab Treatment: Extended Off-Treatment Follow-up From the Randomized CLL14 Study. J Clin Oncol. 2021 Dec 20;39(36):4049-4060. doi: 10.1200/JCO.21.01181. Epub 2021 Oct 28.
Results Reference
derived
PubMed Identifier
32888452
Citation
Al-Sawaf O, Zhang C, Tandon M, Sinha A, Fink AM, Robrecht S, Samoylova O, Liberati AM, Pinilla-Ibarz J, Opat S, Sivcheva L, Le Du K, Fogliatto LM, Niemann CU, Weinkove R, Robinson S, Kipps TJ, Tausch E, Schary W, Ritgen M, Wendtner CM, Kreuzer KA, Eichhorst B, Stilgenbauer S, Hallek M, Fischer K. Venetoclax plus obinutuzumab versus chlorambucil plus obinutuzumab for previously untreated chronic lymphocytic leukaemia (CLL14): follow-up results from a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2020 Sep;21(9):1188-1200. doi: 10.1016/S1470-2045(20)30443-5.
Results Reference
derived
PubMed Identifier
31166681
Citation
Fischer K, Al-Sawaf O, Bahlo J, Fink AM, Tandon M, Dixon M, Robrecht S, Warburton S, Humphrey K, Samoylova O, Liberati AM, Pinilla-Ibarz J, Opat S, Sivcheva L, Le Du K, Fogliatto LM, Niemann CU, Weinkove R, Robinson S, Kipps TJ, Boettcher S, Tausch E, Humerickhouse R, Eichhorst B, Wendtner CM, Langerak AW, Kreuzer KA, Ritgen M, Goede V, Stilgenbauer S, Mobasher M, Hallek M. Venetoclax and Obinutuzumab in Patients with CLL and Coexisting Conditions. N Engl J Med. 2019 Jun 6;380(23):2225-2236. doi: 10.1056/NEJMoa1815281. Epub 2019 Jun 4.
Results Reference
derived

Learn more about this trial

Comparison of the Treatments of Obinutuzumab + Venetoclax Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia

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