A Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+RO5072759 (GA101) in Patients With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma (GADOLIN)
This study is currently recruiting participants.
Verified January 2013 by Genentech
Sponsor:
Genentech
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01059630
First received: January 28, 2010
Last updated: January 11, 2013
Last verified: January 2013
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Purpose
This open-label, multicenter, randomized, Phase III study will investigate the efficacy and safety of RO5072759 (GA101) combined with bendamustine compared with bendamustine alone in patients with rituximab-refractory, indolent Non-Hodgkin's lymphoma (NHL). Patients will be randomized to receive a maximum of 6 cycles of GA101 (1000mg iv infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2 - 6) and then every 2 months until disease progression for up to 2 years plus bendamustine (90 mg/m2 IV, on days 2 and 3 of cycle 1 and days 1 and 2 of cycles 2 - 6) on 28 day cycles or a maximum of 6 cycles of bendamustine alone (120 mg/m2 IV, on days 1 and 2 of cycles 1 - 6) on 28 day cycles.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Hodgkin's Lymphoma |
Drug: bendamustine Drug: RO5072759 |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label, Multicenter, Randomized, Phase III Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+RO5072759 (GA101) in Patients With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma |
Resource links provided by NLM:
Further study details as provided by Genentech:
Primary Outcome Measures:
- Progression-free survival (PFS) [ Time Frame: Time from randomization to first occurrence of progression or relapse, or death ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall survival [ Time Frame: Time from randomization to death ] [ Designated as safety issue: No ]
- Complete response (CR) and overall response (CR or partial response [PR]) [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
- Best response [ Time Frame: Up to 12 months after start of treatment ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 360 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | March 2018 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Arm A |
Drug: bendamustine
Intravenous repeating dose
|
| Experimental: Arm B |
Drug: bendamustine
Intravenous repeating dose
Drug: RO5072759
Intravenous repeating dose
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- History of histologically documented, CD20+, indolent NHL
- Refractory to any previous regimen containing rituximab
- Previously treated with a maximum of four unique chemotherapy containing treatment regimens
- All patients must have at least one bi-dimensionally measurable lesion (>1.5 cm in its largest dimension by CT scan)
Exclusion Criteria:
- Prior use of any monoclonal antibody (other than anti-CD20) within 3 months
- Chemotherapy or other investigational therapy within 28 days
- Prior treatment with bendamustine (within 2 years of the start of study treatment). Patients with prior bendamustine treatment (greater than 2 years prior to the start of study treatment ) are eligible if they meet both of the following criteria: achieved either partial or complete response to the bendamustine regimen of at least 12 months in duration prior to relapse/progression and experienced progression following a regimen containing an alkylating agent
- Prior allogeneic stem cell transplant
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (e.g., patients in whom re-dosing with rituximab would be contraindicated for safety reasons)
- History of sensitivity to mannitol
- Central nervous system lymphoma or histological evidence of transformation to high grade or diffuse large B-cell lymphoma
- History of other malignancy that could affect compliance with the protocol or interpretation of results
- Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with intravenous antibiotics or hospitalization within 4 weeks
- Vaccination with a live vaccine a minimum of 28 days prior to randomization
- Recent major surgery (within 4 weeks), other than for diagnosis
- Presence of positive test results for Hepatitis B or Hepatitis C
- Known history of HIV seropositive status
- Positive test results for human T-lymphotropic virus type I (HTLV 1) virus in endemic countries
- Women who are pregnant or lactating
- Agreement to use an effective form of contraception for the duration of the study
- Ongoing corticosteroid use >30 mg/day prednisone or equivalent
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01059630
Show 117 Study Locations
Contacts
| Contact: Please reference Study ID Number: GAO4753g www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Show 117 Study LocationsSponsors and Collaborators
Genentech
Roche Pharma AG
Investigators
| Study Director: | Clinical Trials | Genentech |
More Information
No publications provided
| Responsible Party: | Genentech |
| ClinicalTrials.gov Identifier: | NCT01059630 History of Changes |
| Other Study ID Numbers: | GAO4753g, GO01297 |
| Study First Received: | January 28, 2010 |
| Last Updated: | January 11, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Genentech:
|
follicular follicular lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Bendamustine Rituximab |
Nitrogen Mustard Compounds Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 22, 2013