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

This study is currently recruiting participants.
Verified May 2012 by Genentech

First Received on August 10, 2011.  
Last Updated on May 30, 2012  
History of Changes
This Clinical Trial Sponsored By: Genentech
Information provided by (Responsible Party): Genentech
ClinicalTrials.gov Identifier: NCT01414855
 

Purpose for Clinical Trial

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.

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

Study Type: Study Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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
Drug Information available for:
Cyclophosphamide
Prednisone
Vincristine sulfate
Doxorubicin
Doxorubicin hydrochloride

U.S. FDA Resources

Further study details as provided by Genentech:

Primary Outcome Measures For Clinical Trial:

  • 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 For Clinical Trial:

  • 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: 80
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 Study 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

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