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Alkylating agents

Rituximab + Bendamustine/Cytarabine for Mantle Cell Lymphoma

Phase 2

Waitlist Available

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Candidate for ASCT

Be older than 18 years old

Must not have

Uncontrolled intercurrent illness

HIV positive on combination antiretroviral therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up disease was assessed after three- and six-cycles of therapy and in long-term follow-up per standard practice every 6 months until the earliest of relapse, death or 5 years. median follow-up in this study cohort was 13 months.

Awards & highlights

No Placebo-Only Group

Summary

This trial found that the combination of Rituximab-Bendamustine followed by Rituximab-Cytarabine improved pre-ASCT complete response rates compared to historical rates.

Who is the study for?

This trial is for newly diagnosed, untreated patients with Mantle Cell Lymphoma who are eligible for a stem cell transplant. They must have measurable disease and agree to pathology review at specified hospitals. Excluded are those allergic to rituximab, on other trials, HIV positive on antiretrovirals, pregnant or breastfeeding women, and those with uncontrolled illnesses or prior lymphoma treatment.

What is being tested?

The study tests Rituximab-Bendamustine followed by Rituximab-Cytarabine in MCL patients to see if it can increase the rate of complete response before stem cell transplantation compared to the historical rate of 55%, while keeping side effects manageable.

What are the potential side effects?

Potential side effects include reactions related to infusion such as fever and chills, low blood counts leading to increased infection risk or bleeding problems, nausea, fatigue and possible organ damage due to inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am eligible for a stem cell transplant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any unmanaged ongoing illnesses.

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I am HIV positive and on combination antiretroviral therapy.

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I have received treatment for lymphoma before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ disease was assessed after three- and six-cycles of therapy and in long-term follow-up per standard practice every 6 months until the earliest of relapse, death or 5 years. median follow-up in this study cohort was 13 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~disease was assessed after three- and six-cycles of therapy and in long-term follow-up per standard practice every 6 months until the earliest of relapse, death or 5 years. median follow-up in this study cohort was 13 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and disease was assessed after three- and six-cycles of therapy and in long-term follow-up per standard practice every 6 months until the earliest of relapse, death or 5 years. median follow-up in this study cohort was 13 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Complete Remission (CR) Rate After 6 Cycles

Secondary study objectives

1 Year Progression-Free Survival

Autologous Stem Cell Transplant (ASCT) Rate

Side effects data

From 2016 Phase 2 & 3 trial • 86 Patients • NCT03002038

Gastrointestinal intolerance

Impaired liver function test

100%

80%

60%

40%

20%

Study treatment Arm

Azathioprine

Rituximab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: RB/RCExperimental Treatment3 Interventions

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituximab

1999

Completed Phase 4

~2990

Cytarabine

2016

Completed Phase 3

~3330