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

Overview[ - collapse ][ - ]

Purpose This open-label, multicenter study will evaluate the efficacy and safety of RO5072759 (GA101) in combination with CHOP chemotherapy in patients with advanced diffuse large B-cell lymphoma. Patients will receive 8 cycles of RO5072759 (1000 mg intravenously on Day 1 of each 21-day cycle, during Cycle 1 RO5072759 will also be infused on Days 8 and 15) in combination with CHOP (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) chemotherapy during cycles 1 to 6. A substudy will investigate the drug-drug interaction of RO5072759 (GA101) with CHOP chemotherapy agents. For the substudy, an additional cohort of 15 patients will be enrolled at a subset of investigational sites.
ConditionLymphoma, B-Cell
InterventionDrug: RO5072759
Drug: cyclophosphamide
Drug: doxorubicin
Drug: vincristine
Drug: prednisone
PhasePhase 2
SponsorGenentech
Responsible PartyGenentech
ClinicalTrials.gov IdentifierNCT01414855
First ReceivedAugust 10, 2011
Last UpdatedApril 7, 2014
Last verifiedApril 2014

Tracking Information[ + expand ][ + ]

First Received DateAugust 10, 2011
Last Updated DateApril 7, 2014
Start DateAugust 2011
Estimated Primary Completion DateFebruary 2017
Current Primary Outcome Measures
  • Complete response (CR), tumor assessments according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007) [Time Frame: approximately 5 years] [Designated as safety issue: No]
  • Overall response rate (ORR: complete response + partial response) [Time Frame: approximately 5 years] [Designated as safety issue: No]
Current Secondary Outcome Measures
  • Safety: Incidence of adverse events [Time Frame: approximately 5 years] [Designated as safety issue: No]
  • Safety: Incidence of Grade 3 or 4 infusion-related adverse events in patients receiving shorter duration infusion (SDI) [Time Frame: approximately 5 years] [Designated as safety issue: No]
  • Progression-free survival: time from first RO5072759 dose to first occurrence of disease progression or relapse or death of any cause [Time Frame: approximately 5 years] [Designated as safety issue: No]
  • Duration of response (CR and OR), defined as first occurrence of CR or OR until first occurrence of relapse or progression or death of any cause [Time Frame: approximately 5 years] [Designated as safety issue: No]
  • Pharmacokinetics: area under the concentration-time curve (AUC) [Time Frame: up to approximately 9 months] [Designated as safety issue: No]
  • Pharmacodynamics: Peripheral blood CD19-positive B-cell count [Time Frame: up to approximately 24 months] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleA Study of RO5072759 (GA101) in Combination With CHOP Chemotherapy in Patients With Previously Untreated Advanced Diffuse Large B-Cell Lymphoma (GATHER)
Official TitleA 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
Brief Summary
This open-label, multicenter study will evaluate the efficacy and safety of RO5072759
(GA101) in combination with CHOP chemotherapy in patients with advanced diffuse large B-cell
lymphoma. Patients will receive 8 cycles of RO5072759 (1000 mg intravenously on Day 1 of
each 21-day cycle, during Cycle 1 RO5072759 will also be infused on Days 8 and 15) in
combination with CHOP (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) chemotherapy
during cycles 1 to 6. A substudy will investigate the drug-drug interaction of RO5072759
(GA101) with CHOP chemotherapy agents. For the substudy, an additional cohort of 15 patients
will be enrolled at a subset of investigational sites.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 2
Study DesignAllocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionLymphoma, B-Cell
InterventionDrug: RO5072759
1000 mg intravenously on Day 1 of each 21-day cycle, 8 cycles; during Cycle 1 administration also on Days 8 and 15
Drug: cyclophosphamide
750 mg/m2 iv, Day 1 of each 21-day cycle, 6 cycles
Drug: doxorubicin
50 mg/m2 iv, Day 1 of each 21-cycle, 6 cycles
Drug: vincristine
1.4 mg/m2 iv, Day 1 of each 21-day cycle, 6 cycles
Drug: prednisone
100 mg/day, Days 1 through 5 of each 21-day cycle, 6 cycles
Study Arm (s)Experimental: Single Arm

Recruitment Information[ + expand ][ + ]

Recruitment StatusActive, not recruiting
Estimated Enrollment100
Estimated Completion DateFebruary 2017
Estimated Primary Completion DateJanuary 2017
Eligibility Criteria
Inclusion Criteria:

- Adult patients, >/= 18 years of age

- Previously untreated 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

- 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, HIV or HTLV-1 infection

- Pregnant or lactating women
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT01414855
Other Study ID NumbersGAO4915g
Has Data Monitoring CommitteeNot Provided
Information Provided ByGenentech
Study SponsorGenentech
CollaboratorsNot Provided
Investigators Study Director: Clinical Trials Genentech
Verification DateApril 2014

Locations[ + expand ][ + ]

United States, Alabama
Birmingham, Alabama, United States, 35291-3300
United States, California
Encinitas, California, United States, 92024
United States, Colorado
Aurora, Colorado, United States, 80045
United States, Colorado
Denver, Colorado, United States, 80218
United States, Connecticut
Norwalk, Connecticut, United States, 06856
United States, Florida
Fort Myers, Florida, United States, 33916
United States, Florida
St Petersburg, Florida, United States, 33719
United States, Georgia
Marietta, Georgia, United States, 30060
United States, Idaho
Coeur D'alene, Idaho, United States, 83814
United States, Illinois
Chicago, Illinois, United States, 60611
United States, Illinois
Peoria, Illinois, United States, 61615-7828
United States, Iowa
Ames, Iowa, United States, 50010
United States, Kentucky
Louisville, Kentucky, United States, 40245
United States, Massachusetts
Worcester, Massachusetts, United States, 01655
United States, Michigan
Ann Arbor, Michigan, United States, 48109-0934
United States, Montana
Missoula, Montana, United States, 59802
United States, Nevada
Las Vegas, Nevada, United States, 89148
United States, New Jersey
Basking Ridge, New Jersey, United States, 07920
United States, New Jersey
Hackensack, New Jersey, United States, 07601
United States, New Mexico
Farmington, New Mexico, United States, 87401
United States, New York
Commack, New York, United States, 11725
United States, New York
New York, New York, United States, 10065
United States, New York
Rockville Centre, New York, United States, 11570
United States, New York
Sleepy Hollow, New York, United States, 10591
United States, North Carolina
High Point, North Carolina, United States, 27262
United States, Oregon
Springfield, Oregon, United States, 97477
United States, South Carolina
Charleston, South Carolina, United States, 29524
United States, Tennessee
Nashville, Tennessee, United States, 37203
United States, Texas
Fort Worth, Texas, United States, 76177
United States, Texas
Houston, Texas, United States, 77030
United States, Texas
Tyler, Texas, United States, 75702
United States, Virginia
Roanoke, Virginia, United States, 24014
United States, Washington
Spokane, Washington, United States, 99208
United States, Washington
Vancouver, Washington, United States, 98684
United States, Washington
Yakima, Washington, United States, 98902
United States, Wisconsin
Green Bay, Wisconsin, United States, 54311