Rituximab/Bendamustine + Rituximab/Cytarabine for Mantle Cell Lymphoma

• Safety of Regimen [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  To assess the safety of this regimen in adult patients <70 years old with untreated MCL; specifically, to assess the incidence of grade 3 and above toxicities that are related to the treatment.
• Partial Remission rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  To estimate the rate of partial remission (PR) using this regimen.
• Estimate Proportion of Patients who Can Successfully Complete Regimen [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  To estimate the proportion of patients who can successfully complete this regimen and proceed to autologous stem cell transplantation (ASCT)
• Estimate Frequency of Minimal Residual Disease after the regimen [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  To estimate the rate of minimal residual disease (MRD)-negativity at the completion of this treatment
• Response rate for patients with blastoid variant [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  To estimate the CR/CRu and PR rate for patients with blastoid variant MCL with this regimen.
• Stable disease rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  Rate of stable disease (SD) using this regimen.
• Progression rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  To estimate the rate of progressive disease (PD) using this regimen.

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.

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.

• Drug: Rituximab
  Cycles 1-6, Intravenously, Day 1 of each cycle
• Drug: Bendamustine
  Cycles 1-3, Intravenously over 30-60 minutes, Days 1 and 2 of each cycle
• Drug: Cytarabine
  Cycles 4-6, Intravenously every 12 hours on days 1 an d2 of each cycle

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