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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 currently recruiting participants.
Verified January 2013 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01414855
First received: August 10, 2011
Last updated: January 28, 2013
Last verified: January 2013
History of Changes
  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.


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:

MedlinePlus related topics: Lymphoma Steroids
U.S. FDA Resources

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 ]

Estimated Enrollment: 95
Study Start Date: August 2011
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (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
Other Name: GA101
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01414855

Contacts
Contact: Please reference Study ID Number: BO25324 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

  Hide Study Locations
Locations
United States, Alabama
Active, not recruiting
Birmingham, Alabama, United States, 35291-3300
United States, California
Active, not recruiting
Encinitas, California, United States, 92024
United States, Colorado
Active, not recruiting
Aurora, Colorado, United States, 80045
Recruiting
Denver, Colorado, United States, 80218
United States, Connecticut
Recruiting
Norwalk, Connecticut, United States, 06856
United States, Florida
Recruiting
Fort Myers, Florida, United States, 33916
Active, not recruiting
Saint Petersburg, Florida, United States, 33705
United States, Georgia
Active, not recruiting
Marietta, Georgia, United States, 30060
United States, Idaho
Completed
Coeur D'alene, Idaho, United States, 83814
United States, Illinois
Active, not recruiting
Chicago, Illinois, United States, 60611
Active, not recruiting
Peoria, Illinois, United States, 61615-7828
United States, Iowa
Completed
Ames, Iowa, United States, 50010
United States, Kentucky
Recruiting
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Recruiting
Worcester, Massachusetts, United States, 01655
United States, Michigan
Active, not recruiting
Ann Arbor, Michigan, United States, 48109-0934
United States, Montana
Completed
Missoula, Montana, United States, 59802
United States, Nevada
Recruiting
Las Vegas, Nevada, United States, 89148
United States, New Jersey
Recruiting
Basking Ridge, New Jersey, United States, 07920
Recruiting
Hackensack, New Jersey, United States, 07601
United States, New Mexico
Active, not recruiting
Farmington, New Mexico, United States, 87401
United States, New York
Recruiting
Commack, New York, United States, 11725
Recruiting
New York, New York, United States, 10065
Recruiting
Rockville Centre, New York, United States, 11570
Recruiting
Sleepy Hollow, New York, United States, 10591
United States, North Carolina
Active, not recruiting
High Point, North Carolina, United States, 27262
United States, Oregon
Active, not recruiting
Springfield, Oregon, United States, 97477
United States, South Carolina
Active, not recruiting
Charleston, South Carolina, United States, 29524
United States, Tennessee
Active, not recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Recruiting
Fort Worth, Texas, United States, 76177
Active, not recruiting
Houston, Texas, United States, 77030
Recruiting
Houston, Texas, United States, 77030
Active, not recruiting
San Antonio, Texas, United States, 78229
Active, not recruiting
Tyler, Texas, United States, 75702
United States, Virginia
Active, not recruiting
Roanoke, Virginia, United States, 24014
United States, Washington
Recruiting
Spokane, Washington, United States, 99208
Recruiting
Vancouver, Washington, United States, 98684
Recruiting
Yakima, Washington, United States, 98902
United States, Wisconsin
Active, not recruiting
Green Bay, Wisconsin, United States, 54308
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: January 28, 2013
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
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
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on May 21, 2013