This trial is active, not recruiting.

Condition mantle cell lymphoma
Treatments rituximab, bendamustine, cytarabine
Phase phase 2
Target CD20
Sponsor Dana-Farber Cancer Institute
Collaborator Massachusetts General Hospital
Start date August 2012
End date May 2015
Trial size 23 participants
Trial identifier NCT01661881, 12-168


This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational combination of drugs to learn whether the combination of drugs works in treating a specific cancer. "Investigational" means that the combination of drugs is still being studied and that research doctors are trying to find out more about it-such as the safest dose to use, the side effects it may cause, and if the combination of drus is effective for treating different types of cancer. It also means the FDA has not yet approved this combination of drugs for your type of cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Rituximab-Bendamustine Rituximab-Cytarabine
Cycles 1-6, Intravenously, Day 1 of each cycle
Cycles 1-3, Intravenously over 30-60 minutes, Days 1 and 2 of each cycle
Cycles 4-6, Intravenously every 12 hours on days 1 an d2 of each cycle

Primary Outcomes

Complete Remission rate of Rituximab/Bendamustine and Rituximab/Cytarabine
time frame: 6 months

Secondary Outcomes

Safety of Regimen
time frame: 6 months
Partial Remission rate
time frame: 6 months
Estimate Proportion of Patients who Can Successfully Complete Regimen
time frame: 6 months
Estimate Frequency of Minimal Residual Disease after the regimen
time frame: 6 months
Response rate for patients with blastoid variant
time frame: 6 months
Stable disease rate
time frame: 6 months
Progression rate
time frame: 6 months

Eligibility Criteria

Male or female participants from 18 years up to 69 years old.

Inclusion Criteria: - Mandatory pathologic review of the diagnostic specimen(s) at Brigham and Women's Hospital or Massachusetts General Hospital - Measurable disease - Candidate for ASCT Exclusion Criteria: - Prior anti-lymphoma therapy - Pregnant or breastfeeding - Hypersensitivity to rituximab - Uncontrolled intercurrent illness - Receiving other study agents - HIV positive on combination antiretroviral therapy

Additional Information

Official title A Phase II Study of Rituximab/Bendamustine Followed by Rituximab/Cytarabine for Untreated Mantle Cell Lymphoma
Description Patients enrolling in this study will receive a maximum of six cycles of the study drugs. Each cycle is 28 days in length. They will receive Rituximab-Bendamustine (RB) for the first 3 cycles. This treatment will consist of Rituximab given by infusion into a vein (intravenous) on day 1 of each cycle and Bendamustine given by infusion into a vein (over approximately 30-60 minutes) daily on days 1 and 2 of each cycle. They will then receive Rituximab-Cytarabine (RC) for the last 3 cycles (with the first cycle administered 28 days after the last RB cycle). This treatment will consist of Rituximab given by infusion into a vein (intravenous) on day 1 of each cycle and cytarabine by infusion into a vein (intravenous) every 12 hours on days 1 and 2 of each cycle. It is expected that those 3 cycles will be delivered in the hospital, over 2-3 days each time. It is expected that patients will proceed to autologous stem cell transplantation at the conclusion of this study. However, the stem cell transplantation will not be performed as part of this study.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Dana-Farber Cancer Institute.