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Rituximab/Bendamustine + Rituximab/Cytarabine for Mantle Cell Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01661881
First Posted: August 10, 2012
Last Update Posted: January 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
Philippe Armand, MD, PhD, Dana-Farber Cancer Institute
July 15, 2012
August 10, 2012
September 15, 2016
January 12, 2017
January 12, 2017
August 2012
February 2015   (Final data collection date for primary outcome measure)
Complete Remission (CR) Rate After 6 Cycles [ Time Frame: 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. ]
The 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.
Complete Remission rate of Rituximab/Bendamustine and Rituximab/Cytarabine [ Time Frame: 6 months ]
CR and CRu rate of an alternating regimen of Rituximab-Bendamustine and Rituximab-Cytarabine for adult patients younger than 70 years old with untreated MCL.
Complete list of historical versions of study NCT01661881 on ClinicalTrials.gov Archive Site
  • 1 Year Progression-Free Survival [ Time Frame: 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. ]
    1-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).
  • Autologous Stem Cell Transplant (ASCT) Rate [ Time Frame: All patients were followed for continuation to ASCT upon completion of induction therapy. Patients usually proceed to ASCT within 3 months of completing induction. ]
    ASCT rate is the proportion of patients who completed therapy and proceeded to autologous stem cell transplant (ASCT)
  • Safety of Regimen [ Time Frame: 6 months ]
    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 ]
    To estimate the rate of partial remission (PR) using this regimen.
  • Estimate Proportion of Patients who Can Successfully Complete Regimen [ Time Frame: 6 months ]
    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 ]
    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 ]
    To estimate the CR/CRu and PR rate for patients with blastoid variant MCL with this regimen.
  • Stable disease rate [ Time Frame: 6 months ]
    Rate of stable disease (SD) using this regimen.
  • Progression rate [ Time Frame: 6 months ]
    To estimate the rate of progressive disease (PD) using this regimen.
Not Provided
Not Provided
 
Rituximab/Bendamustine + Rituximab/Cytarabine for Mantle Cell Lymphoma
A Phase II Study of Rituximab/Bendamustine Followed by Rituximab/Cytarabine for Untreated Mantle Cell Lymphoma
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.

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.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Mantle Cell Lymphoma
  • Drug: Rituximab
    Other Name: Rituxan
  • Drug: Bendamustine
    Other Name: Treanda
  • Drug: Cytarabine
    Other Name: Depocyt
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.

Interventions:
  • Drug: Rituximab
  • Drug: Bendamustine
  • Drug: Cytarabine
Armand P, Redd R, Bsat J, Mayuram S, Giardino A, Fisher DC, LaCasce AS, Jacobson C, Davids MS, Brown JR, Weng L, Wilkins J, Faham M, Freedman AS, Joyce R, Jacobsen ED. A phase 2 study of Rituximab-Bendamustine and Rituximab-Cytarabine for transplant-eligible patients with mantle cell lymphoma. Br J Haematol. 2016 Apr;173(1):89-95. doi: 10.1111/bjh.13929. Epub 2016 Jan 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
23
March 2019
February 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 69 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01661881
12-168
Yes
Not Provided
Plan to Share IPD: No
Philippe Armand, MD, PhD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
Massachusetts General Hospital
Study Chair: Philippe Armand, MD, PhD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP