U.S. flag

An official website of the United States government

Skip to main page content
Active, not recruiting

Rituximab/​Bendamustine + Rituximab/​Cytarabine for Mantle Cell Lymphoma

ClinicalTrials.gov ID NCT01661881
Sponsor Dana-Farber Cancer Institute
Information provided by Philippe Armand, MD, PhD, Dana-Farber Cancer Institute (Responsible Party)
Last Update Posted 2024-06-03
Bookmark

Study Overview

Brief Summary
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.
Detailed 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.
Show less
Official Title
A Phase II Study of Rituximab/Bendamustine Followed by Rituximab/Cytarabine for Untreated Mantle Cell Lymphoma
Conditions
Mantle Cell Lymphoma
Intervention / Treatment
  • Drug: Rituximab
  • Drug: Bendamustine
  • Drug: Cytarabine
  • Drug: Rituximab
  • Drug: Bendamustine
  • Drug: Cytarabine
Other Study ID Numbers
  • 12-168
Study Start (Actual)
2012-08-16
Primary Completion (Actual)
2015-02
Study Completion (Estimated)
2025-03
Enrollment (Actual)
23
Study Type
Interventional
Phase
Phase 2

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
Description

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
Show less
Ages Eligible for Study
18 Years to 69 Years (AdultOlder Adult )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

/
Design Details
Primary Purpose : Treatment
Allocation : N/A
Interventional Model : Single Group Assignment
Masking : None (Open Label)

Arms and Interventions

Participant Group/Arm Intervention/Treatment
Participant Group/Arm Experimental: RB/RC

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.

Intervention/Treatment Drug: Rituximab
  • Other Names:
    • Rituxan
Drug: Bendamustine
  • Other Names:
    • Treanda
Drug: Cytarabine
  • Other Names:
    • Depocyt
Primary Outcome Measures
Outcome Measure Measure Description Time Frame
Complete Remission (CR) Rate After 6 CyclesThe CR rate is defined as the proportion of patients who after 6 cycles of therapy achieve complete remission based on the International Working Group (IWG) Criteria (Cheson et al, 1999), using CT scans. CR or CRu (CR unconfirmed) by CT scans was defined by standard IWG criteria, ie resolution of all abnormal adenopathy and organomegaly, and clearance of marrow disease when present at baseline.Disease was assessed after three- and six-cycles of therapy, up to approximately 25 weeks. All patients completed 6 cycles of therapy with a cycle duration of 28 days.
Secondary Outcome Measures
Outcome Measure Measure Description Time Frame
1 Year Progression-Free Survival1-year progression-free survival is the probability of patients remaining alive and progression-free at 1 year from study entry estimated using Kaplan-Meier methods. Disease progression was based on the International Working Group (IWG) Criteria (Cheson et al, 1999).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.
Autologous Stem Cell Transplant (ASCT) RateASCT rate is the proportion of patients who completed therapy and proceeded to autologous stem cell transplant (ASCT)All patients were followed for continuation to ASCT upon completion of induction therapy. Patients usually proceed to ASCT within 3 months of completing induction.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.
Sponsor
Dana-Farber Cancer Institute
Collaborators
  • Massachusetts General Hospital
Investigators
  • Study Chair:Philippe Armand, MD, PhD,Dana-Farber Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
2012-07-15
First Submitted that Met QC Criteria
2012-08-07
First Posted (Estimated)
2012-08-10
Results Reporting Dates
Results First Submitted
2016-09-15
Results First Submitted that Met QC Criteria
2016-11-15
Results First Posted (Estimated)
2017-01-12
Study Record Updates
Last Update Submitted that met QC Criteria
2024-05-30
Last Update Posted
2024-06-03
Last Verified
2024-05

More Information

/

Keywords Provided by Philippe Armand, MD, PhD, Dana-Farber Cancer Institute
Additional Relevant MeSH Terms

Plan to Share Individual Participant Data (IPD)?
No