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A Study of Obinutuzumab [RO5072759 (GA101)] in Combination With CHOP Chemotherapy in Patients With Previously Untreated Advanced Diffuse Large B-Cell Lymphoma (GATHER)

Primary Purpose

Lymphoma, B-Cell

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
obinutuzumab
cyclophosphamide
doxorubicin
prednisone
vincristine
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, B-Cell

Eligibility Criteria

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

Inclusion Criteria:

  • Adult patients, ≥18 years of age
  • Previously untreated cluster of differentiation antigen 20 (CD20)-positive diffuse large B-cell lymphoma
  • Ann Arbour Stage III/IV and bulky II (mass >10 cm)
  • At least one bi-dimensionally measurable lesion defined as >1.5 cm in its largest dimension by CT scan
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
  • Left ventricular ejection fraction ≥50%
  • Adequate hematologic function

Exclusion Criteria:

  • Transformed lymphoma (follicular IIIB) if previously treated with chemotherapy or immunotherapy
  • Prior therapy for diffuse large B-cell lymphoma except for nodal biopsy or local irradiation
  • Central nervous system (CNS) lymphoma, primary mediastinal large cell lymphoma, primary cutaneous lymphoma, primary effusion lymphoma
  • Patients who received cytotoxic drugs or rituximab as part of their treatment for another condition (e.g. rheumatoid arthritis) or prior use of an anti-CD20 antibody
  • Chemotherapy or other investigational therapy within 28 days prior to the start of Cycle 1
  • Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines
  • History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
  • History of other malignancy, except for curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix, or malignancy treated with or without curative intent and in remission without treatment for ≥2 years prior to enrolment
  • Positive for hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or human T-cell leukemia virus (HTLV-1) infection
  • Pregnant or lactating women

Sites / Locations

  • University of Alabama at Birmingham
  • cCare
  • University of Colorado Cancer Center Department of Hematology
  • Rocky Mountain Cancer Ctr - Denver (Williams)
  • Norwalk Hospital
  • Florida Cancer Specialists; Department of Oncology
  • Florida Cancer Specialists; Saint Petersburg
  • Northwest Georgia Oncology Centers PC - Marietta
  • Kootenai Medical Center
  • Northwestern University; Robert H. Lurie Comp Can Ctr
  • Onc Hem Assoc of Central IL
  • McFarland Clinic
  • Jewish Cancer Care
  • University of Massachusetts Medical School
  • University of Michigan
  • MT Cancer Inst Fndtn; MT Can Spec
  • Comprehensive Cancer Centers of Nevada
  • MSKCC at Basking Ridge
  • Hackensack University Medical Center
  • San Juan Oncology Associates
  • Memorial Sloan-Kettering; Cancer Center
  • Memorial Sloan Kettering Cancer Center
  • MSKCC at Mercy Med Ctr
  • MSKCC at Sleepy Hollow
  • Emerywood Hematology and Onc
  • Willamette Valley Cancer Insitute and Research Center
  • Medical University of SC (MUSC)
  • SCRI-Tennessee Oncology
  • Onc & Hem Assoc; USO Cent Pharm
  • MD Anderson Cancer Center Department of Lymphoma & Myeloma
  • Methodist Hospital Research Institute
  • Cancer Therapy & Research Center
  • USO - Tyler Cancer Ctr
  • Blue Ridge Cancer Care - Roanoke
  • Medical Oncology Associates
  • Northwest Cancer Specialists - Vancouver
  • Yakima Valley Memorial Hospital/North Star Lodge
  • Aurora Bay Care Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

obinutuzumab + CHOP

Arm Description

Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy (cyclophosphamide, doxorubicin, vincristine and prednisone) for 6 cycles.

Outcomes

Primary Outcome Measures

Complete Response (CR) Rate as Assessed by the Investigator at the End of Treatment
Complete response rate is defined as the percentage of participants with Complete Response (CR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the investigator using regular clinical and laboratory examinations, fluorodeoxyglucose-positron emission tomography (FDG-PET) and computed tomography (CT). CR is the disappearance of all evidence of disease.
Overall Response Rate (ORR) as Assessed by the Investigator at the End of Treatment
Overall response rate was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the investigator using regular clinical and laboratory examinations, FDG-PET and computed tomography (CT). CR is the disappearance of all evidence of disease. PR is at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites.

Secondary Outcome Measures

Complete Response (CR) Rate as Assessed by the Independent Review Facility (IRF) at the End of Treatment
Complete response rate is defined as the percentage of participants with Complete Response (CR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the IRF using CT scans, PET scans and pertinent clinical information. CR is the disappearance of all evidence of disease.
Overall Response Rate (ORR) as Assessed by the IRF at the End of Treatment
Overall response rate was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the IRF using CT scans, PET scans and pertinent clinical information. CR is the disappearance of all evidence of disease. PR is at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites.
Progression-Free Survival (PFS) as Assessed by the Investigator
PFS was defined as the time from the date of the first dose of study treatment until the date of disease progression, relapse, or death from any cause.
Duration of Response (DOR)
DOR is defined as first occurrence of documented response (CR or PR) until the first occurrence of relapse or progression or death of any cause. CR: disappearance of all evidence of disease. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites.
Percentage of Participants With Adverse Events as a Measure of Safety
An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug or other protocol-imposed intervention. Preexisting conditions that worsened during the study were reported as adverse events.
Number of Participants With Grade 3 to 4 Infusion-Related (IRR) Adverse Events (AE) in Participants Receiving Shorter Duration Infusion (SDI)
SDI 120 is a shorter duration infusion of 120 minutes and SDI 90 is shorter duration infusion of 90 minutes. Grade 3 IRR AE: Prolonged (e.g., not rapidly responsive to symptomatic medication and/or brief interruption of infusion); recurrence of symptoms following initial improvement; hospitalization indicated for clinical sequelae. Grade 4 IRR AE: Life-threatening consequences; urgent intervention indicated.
Pharmacokinetics (PK): Maximum Concentration Observed (Cmax) for Obinutuzumab
Blood was collected for PK Parameters. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in micrograms per milliliter (μg/mL).
Pharmacokinetics: Terminal Half-Life (t1/2) for Obinutuzumab
T1/2 is the time required for the concentration of the drug to reach half of its original value. Blood was collected for PK Parameters. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in days
Pharmacokinetics: Clearance (Cl) for Obinutuzumab
Cl is the volume of serum cleared of the drug per unit of time. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in milliliters/day (mL/day).
Pharmacokinetics: Volume of Distribution (V) for Obinutuzumab
V is the apparent volume in which a drug is distributed in the body. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in milliliters (mL).
Pharmacokinetics: Area Under the Concentration-Time Curve 7 Day (AUC7day)
Blood was collected for PK parameters. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in in day times micrograms per milliliter (day*μg/mL).
Pharmacodynamics: Peripheral Blood CD19-positive B-cell Count

Full Information

First Posted
August 10, 2011
Last Updated
April 24, 2018
Sponsor
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01414855
Brief Title
A Study of Obinutuzumab [RO5072759 (GA101)] in Combination With CHOP Chemotherapy in Patients With Previously Untreated Advanced Diffuse Large B-Cell Lymphoma (GATHER)
Official Title
A Phase II, Open-Label, Multicenter Study of Efficacy, Safety, and Biomarkers in Patients With Previously Untreated Advanced Diffuse Large B-Cell Lymphoma Treated With GA101 (RO5072759) in Combination With CHOP Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
August 31, 2011 (Actual)
Primary Completion Date
December 31, 2013 (Actual)
Study Completion Date
December 23, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This open-label, multicenter study will evaluate the efficacy and safety of obinutuzumab [RO5072759 (GA101)] in combination with CHOP (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) chemotherapy in patients with advanced diffuse large B-cell lymphoma. Patients will receive 8 cycles of obinutuzumab (1000 mg intravenously on Day 1 of each 21-day cycle, during Cycle 1 obinutuzumab will also be infused on Days 8 and 15) in combination with CHOP chemotherapy on Day 1 of cycles 1 to 6. A substudy will investigate the drug-drug interaction of obinutuzumab with CHOP chemotherapy agents. For the substudy, an additional cohort of approximately 15 patients are planned to be enrolled at a subset of investigational sites.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, B-Cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
obinutuzumab + CHOP
Arm Type
Experimental
Arm Description
Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy (cyclophosphamide, doxorubicin, vincristine and prednisone) for 6 cycles.
Intervention Type
Drug
Intervention Name(s)
obinutuzumab
Intervention Description
1000 mg intravenously on Day 1 of each 21-day cycle, 8 cycles; during Cycle 1 administration also on Days 8 and 15.
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Description
750 mg/m^2 intravenous (IV), Day 1 of each 21-day cycle, 6 cycles.
Intervention Type
Drug
Intervention Name(s)
doxorubicin
Intervention Description
50 mg/m^2 IV, Day 1 of each 21-cycle, 6 cycles.
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Description
100 mg/day, Days 1 through 5 of each 21-day cycle, 6 cycles.
Intervention Type
Drug
Intervention Name(s)
vincristine
Intervention Description
1.4 mg/m^2 IV, Day 1 of each 21-day cycle, 6 cycles.
Primary Outcome Measure Information:
Title
Complete Response (CR) Rate as Assessed by the Investigator at the End of Treatment
Description
Complete response rate is defined as the percentage of participants with Complete Response (CR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the investigator using regular clinical and laboratory examinations, fluorodeoxyglucose-positron emission tomography (FDG-PET) and computed tomography (CT). CR is the disappearance of all evidence of disease.
Time Frame
From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)
Title
Overall Response Rate (ORR) as Assessed by the Investigator at the End of Treatment
Description
Overall response rate was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the investigator using regular clinical and laboratory examinations, FDG-PET and computed tomography (CT). CR is the disappearance of all evidence of disease. PR is at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites.
Time Frame
From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)
Secondary Outcome Measure Information:
Title
Complete Response (CR) Rate as Assessed by the Independent Review Facility (IRF) at the End of Treatment
Description
Complete response rate is defined as the percentage of participants with Complete Response (CR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the IRF using CT scans, PET scans and pertinent clinical information. CR is the disappearance of all evidence of disease.
Time Frame
From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)
Title
Overall Response Rate (ORR) as Assessed by the IRF at the End of Treatment
Description
Overall response rate was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the IRF using CT scans, PET scans and pertinent clinical information. CR is the disappearance of all evidence of disease. PR is at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites.
Time Frame
From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)
Title
Progression-Free Survival (PFS) as Assessed by the Investigator
Description
PFS was defined as the time from the date of the first dose of study treatment until the date of disease progression, relapse, or death from any cause.
Time Frame
From the first dose of study treatment to PFS assessment (up to 64 months)
Title
Duration of Response (DOR)
Description
DOR is defined as first occurrence of documented response (CR or PR) until the first occurrence of relapse or progression or death of any cause. CR: disappearance of all evidence of disease. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites.
Time Frame
From the response assessment to relapse, progression, or death (up to 64 months)
Title
Percentage of Participants With Adverse Events as a Measure of Safety
Description
An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug or other protocol-imposed intervention. Preexisting conditions that worsened during the study were reported as adverse events.
Time Frame
From the first dose of study treatment to end of study (up to 5 years 4 months)
Title
Number of Participants With Grade 3 to 4 Infusion-Related (IRR) Adverse Events (AE) in Participants Receiving Shorter Duration Infusion (SDI)
Description
SDI 120 is a shorter duration infusion of 120 minutes and SDI 90 is shorter duration infusion of 90 minutes. Grade 3 IRR AE: Prolonged (e.g., not rapidly responsive to symptomatic medication and/or brief interruption of infusion); recurrence of symptoms following initial improvement; hospitalization indicated for clinical sequelae. Grade 4 IRR AE: Life-threatening consequences; urgent intervention indicated.
Time Frame
From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)
Title
Pharmacokinetics (PK): Maximum Concentration Observed (Cmax) for Obinutuzumab
Description
Blood was collected for PK Parameters. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in micrograms per milliliter (μg/mL).
Time Frame
Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12
Title
Pharmacokinetics: Terminal Half-Life (t1/2) for Obinutuzumab
Description
T1/2 is the time required for the concentration of the drug to reach half of its original value. Blood was collected for PK Parameters. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in days
Time Frame
Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12
Title
Pharmacokinetics: Clearance (Cl) for Obinutuzumab
Description
Cl is the volume of serum cleared of the drug per unit of time. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in milliliters/day (mL/day).
Time Frame
Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12
Title
Pharmacokinetics: Volume of Distribution (V) for Obinutuzumab
Description
V is the apparent volume in which a drug is distributed in the body. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in milliliters (mL).
Time Frame
Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12
Title
Pharmacokinetics: Area Under the Concentration-Time Curve 7 Day (AUC7day)
Description
Blood was collected for PK parameters. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in in day times micrograms per milliliter (day*μg/mL).
Time Frame
Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12
Title
Pharmacodynamics: Peripheral Blood CD19-positive B-cell Count
Time Frame
Up to approximately 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients, ≥18 years of age Previously untreated cluster of differentiation antigen 20 (CD20)-positive diffuse large B-cell lymphoma Ann Arbour Stage III/IV and bulky II (mass >10 cm) At least one bi-dimensionally measurable lesion defined as >1.5 cm in its largest dimension by CT scan Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 Left ventricular ejection fraction ≥50% Adequate hematologic function Exclusion Criteria: Transformed lymphoma (follicular IIIB) if previously treated with chemotherapy or immunotherapy Prior therapy for diffuse large B-cell lymphoma except for nodal biopsy or local irradiation Central nervous system (CNS) lymphoma, primary mediastinal large cell lymphoma, primary cutaneous lymphoma, primary effusion lymphoma Patients who received cytotoxic drugs or rituximab as part of their treatment for another condition (e.g. rheumatoid arthritis) or prior use of an anti-CD20 antibody Chemotherapy or other investigational therapy within 28 days prior to the start of Cycle 1 Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines History of severe allergic or anaphylactic reactions to monoclonal antibody therapy History of other malignancy, except for curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix, or malignancy treated with or without curative intent and in remission without treatment for ≥2 years prior to enrolment Positive for hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or human T-cell leukemia virus (HTLV-1) infection Pregnant or lactating women
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
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
cCare
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
University of Colorado Cancer Center Department of Hematology
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Rocky Mountain Cancer Ctr - Denver (Williams)
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Norwalk Hospital
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06856
Country
United States
Facility Name
Florida Cancer Specialists; Department of Oncology
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901-8101
Country
United States
Facility Name
Florida Cancer Specialists; Saint Petersburg
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33719
Country
United States
Facility Name
Northwest Georgia Oncology Centers PC - Marietta
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Kootenai Medical Center
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Northwestern University; Robert H. Lurie Comp Can Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Onc Hem Assoc of Central IL
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615-7828
Country
United States
Facility Name
McFarland Clinic
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
Jewish Cancer Care
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40245
Country
United States
Facility Name
University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0934
Country
United States
Facility Name
MT Cancer Inst Fndtn; MT Can Spec
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
MSKCC at Basking Ridge
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
San Juan Oncology Associates
City
Farmington
State/Province
New Mexico
ZIP/Postal Code
87401
Country
United States
Facility Name
Memorial Sloan-Kettering; Cancer Center
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
MSKCC at Mercy Med Ctr
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11570
Country
United States
Facility Name
MSKCC at Sleepy Hollow
City
Sleepy Hollow
State/Province
New York
ZIP/Postal Code
10591
Country
United States
Facility Name
Emerywood Hematology and Onc
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Willamette Valley Cancer Insitute and Research Center
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Facility Name
Medical University of SC (MUSC)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
SCRI-Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Onc & Hem Assoc; USO Cent Pharm
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76177
Country
United States
Facility Name
MD Anderson Cancer Center Department of Lymphoma & Myeloma
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Methodist Hospital Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Cancer Therapy & Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
USO - Tyler Cancer Ctr
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Blue Ridge Cancer Care - Roanoke
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Medical Oncology Associates
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Facility Name
Northwest Cancer Specialists - Vancouver
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States
Facility Name
Yakima Valley Memorial Hospital/North Star Lodge
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States
Facility Name
Aurora Bay Care Medical Center
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54311
Country
United States

12. IPD Sharing Statement

Citations:
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
30277102
Citation
Sharman JP, Forero-Torres A, Costa LJ, Flinn IW, Inhorn L, Kelly K, Bessudo A, Fayad LE, Kaminski MS, Evens AM, Flowers CR, Sahin D, Mundt KE, Sandmann T, Fingerle-Rowson G, Vignal C, Mobasher M, Zelenetz AD. Obinutuzumab plus CHOP is effective and has a tolerable safety profile in previously untreated, advanced diffuse large B-cell lymphoma: the phase II GATHER study. Leuk Lymphoma. 2019 Apr;60(4):894-903. doi: 10.1080/10428194.2018.1515940. Epub 2018 Oct 2.
Results Reference
derived

Learn more about this trial

A Study of Obinutuzumab [RO5072759 (GA101)] in Combination With CHOP Chemotherapy in Patients With Previously Untreated Advanced Diffuse Large B-Cell Lymphoma (GATHER)

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