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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01414855
First received: August 10, 2011
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This open-label, multicenter study will evaluate the efficacy and safety of RO50 72759 (GA101) in combination with CHOP chemotherapy in patients with advanced di ffuse large B-cell lymphoma. Patients will receive 8 cycles of RO5072759 (1000 m g intravenously on Day 1 of each 21-day cycle, during Cycle 1 RO5072759 will als

o be infused on Days 8 and 15) in combination with CHOP (Cyclophosphamide, Doxor ubicin, Vincristine, Prednisone) chemotherapy during cycles 1 to 6. A substudy w ill investigate the drug-drug interaction of RO5072759 (GA101) with CHOP chemoth erapy agents. For the substudy, an additional cohort of 15 patients will be enro lled at a subset of investigational sites.


Condition Intervention Phase
Lymphoma, B-Cell
Drug: RO5072759
Drug: cyclophosphamide
Drug: doxorubicin
Drug: vincristine
Drug: prednisone
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Genentech:

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 ]

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 ]

Enrollment: 100
Study Start Date: August 2011
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01414855

  Hide Study Locations
Locations
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
Denver, Colorado, United States, 80218
United States, Connecticut
Norwalk, Connecticut, United States, 06856
United States, Florida
Fort Myers, Florida, United States, 33916
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
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
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
New York, New York, United States, 10065
Rockville Centre, New York, United States, 11570
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
Houston, Texas, United States, 77030
Tyler, Texas, United States, 75702
United States, Virginia
Roanoke, Virginia, United States, 24014
United States, Washington
Spokane, Washington, United States, 99208
Vancouver, Washington, United States, 98684
Yakima, Washington, United States, 98902
United States, Wisconsin
Green Bay, Wisconsin, United States, 54311
Sponsors and Collaborators
Genentech
Investigators
Study Director: Clinical Trials Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01414855     History of Changes
Other Study ID Numbers: GAO4915g
Study First Received: August 10, 2011
Last Updated: August 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Cyclophosphamide
Liposomal doxorubicin
Obinutuzumab
Doxorubicin
Prednisone
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014