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: July 7, 2014
Last verified: July 2014

August 10, 2011
July 7, 2014
August 2011
January 2017   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01414855 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of RO5072759 (GA101) in Combination With CHOP Chemotherapy in Patients With Previously Untreated Advanced Diffuse Large B-Cell Lymphoma (GATHER)
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

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma, B-Cell
  • 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
Experimental: Single Arm
Interventions:
  • Drug: RO5072759
  • Drug: cyclophosphamide
  • Drug: doxorubicin
  • Drug: vincristine
  • Drug: prednisone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
February 2017
January 2017   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01414855
GAO4915g
Not Provided
Genentech
Genentech
Not Provided
Study Director: Clinical Trials Genentech
Genentech
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP