Rituximab/Bendamustine + Rituximab/Cytarabine for Mantle Cell Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Dana-Farber Cancer Institute
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
Philippe Armand, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01661881
First received: July 15, 2012
Last updated: February 3, 2014
Last verified: February 2014

July 15, 2012
February 3, 2014
August 2012
August 2014   (final data collection date for primary outcome measure)
Complete Remission rate of Rituximab/Bendamustine and Rituximab/Cytarabine [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01661881 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
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

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Mantle Cell Lymphoma
  • 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
Experimental: Treatment Arm
Rituximab-Bendamustine Rituximab-Cytarabine
Interventions:
  • Drug: Rituximab
  • Drug: Bendamustine
  • Drug: Cytarabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
23
April 2015
August 2014   (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
Both
18 Years to 69 Years
No
Contact: Philippe Armand, MD 6176322305 parmand@partners.org
Contact: Caitlin Tesmer 617-632-6840 ctesmer1@partners.org
United States
 
NCT01661881
12-168
Yes
Philippe Armand, MD, PhD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
Massachusetts General Hospital
Not Provided
Dana-Farber Cancer Institute
February 2014

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