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
  Purpose

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.


Condition Intervention Phase
Mantle Cell Lymphoma
Drug: Rituximab
Drug: Bendamustine
Drug: Cytarabine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Rituximab/Bendamustine Followed by Rituximab/Cytarabine for Untreated Mantle Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 23
Study Start Date: August 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Arm
Rituximab-Bendamustine Rituximab-Cytarabine
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01661881

Contacts
Contact: Philippe Armand, MD 6176322305 parmand@partners.org
Contact: Caitlin Tesmer 617-632-6840 ctesmer1@partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02215
Contact: Philippe Armand, MD    617-632-2305    parmand@partners.org   
Principal Investigator: Philippe Armand, MD         
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Philippe Armand, MD    617-632-2305    parmand@partners.org   
Principal Investigator: Philippe Armand, MD         
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02113
Contact: Ephraim Hochberg, MD    617-726-8743    ehochberg@partners.org   
Principal Investigator: Ephraim Hochberg, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Philippe Armand, MD, PhD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01661881     History of Changes
Other Study ID Numbers: 12-168
Study First Received: July 15, 2012
Last Updated: February 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
Newly diagnosed

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Bendamustine
Cytarabine
Rituximab
Alkylating Agents
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antiviral Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014