Rituximab/Bendamustine + Rituximab/Cytarabine for Mantle Cell Lymphoma

Dana-Farber Cancer Institute

Status and phase: Active, not recruiting; Phase 2

Conditions: Mantle Cell Lymphoma

Treatments: Drug: Rituximab; Drug: Cytarabine; Drug: Bendamustine

Study type: Interventional

Funder types: Other

Identifiers

NCT01661881

12-168

Details and patient eligibility

About

Mantle cell lymphoma (MCL) is not curable with conventional therapy. This study sought to improve upon standard of care in newly diagnosed, untreated MCL patients who were transplant-eligible using drugs already established as active in MCL. The combination of Rituximab-Bendamustine followed by Rituximab-Cytarabine (RB/RC) was expected to maximize pre-ASCT complete response (CR) rate compared to historical rates approximating 55% with tolerable toxicity.

Full description

This was a PII single-arm design to determine whether the regimen looked promising for further study.

Primary Objective

• To evaluate the efficacy of an alternating regimen of Rituximab-Bendamustine and Rituximab-Cytarabine (RB/RC) using the CR/Cru rate.

Secondary Objectives

• To assess safety.
• To estimate the rate of complete remission (CR), unconfirmed CR (CRu), partial remission (PR), stable disease (SD) and progressive disease (PD).
• To estimate the rate of successful stem cell mobilization after RB/RC in responding patients.
• To estimate the proportion of patients who can successfully complete the regimen and proceed to autologous stem cell transplantation (ASCT).
• To estimate the rate of neutrophil and platelet engraftment after ASCT.
• To estimate the CR/CRu and PR rate for patients with blastoid variant MCL.
• To estimate the rate of minimal residual disease (MRD)-negativity at treatment completion.

Enrollment: 23 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

RB/RC

Experimental group

Description:

Patients received 3 cycles of outpatient RB (rituximab 375 mg/m2 day 1, bendamustine 90 mg/m2 days 1 and 2 of a 4-week cycle), followed by interim CT restaging. Patients with progressive disease (PD) went off study. Those with stable disease (SD) or better went on to receive three cycles of inpatient RC (rituximab 375 mg/m2 day 1, cytarabine 3 g/m2 every 12 h for 4 doses). The cytarabine was dose reduced to: 1. 2 g/m2 for age \>60 years old, creatinine 114.9-176.8 lmol/l (for patients ≤60 years old), and pre-existing neurotoxicity; 2. 1.5 g/m2 for age \>60 years old AND creatinine 114.9-176.8 lmol/l, or for age \>60 years old AND pre-existing neurotoxicity; 3. 1 g/m2 for age \> 60 years old AND creatinine 114.9-176.8 lmol/l AND pre-existing neurotoxicity. Stem cell mobilization and collection, ASCT and post-transplantation supportive care were performed per institutional standard and not as part of this study.

Treatment:

Drug: Bendamustine

Drug: Cytarabine

Drug: Rituximab