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Maintenance Therapy: Lenalidomide Following Bendamustine and Rituximab Induction Therapy for Chronic Lymphocytic Leukemia

This study is currently recruiting participants.
Verified January 2013 by Yale University
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Terri Parker, Yale University
ClinicalTrials.gov Identifier:
NCT01465230
First received: October 28, 2011
Last updated: January 14, 2013
Last verified: January 2013
History of Changes
  Purpose

This study will determine whether or not Lenalidomide improves effectiveness of treatment for chronic lymphocytic leukemia following chemotherapy with two drugs commonly used to treat the disease (bendamustine and rituximab).


Condition Intervention Phase
Chronic Lymphocytic Leukemia
 Drug: Maintenance lenalidomide
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Maintenance Therapy With Lenalidomide Following Bendamustine and Rituximab Induction Therapy for Chronic Lymphocytic Leukemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Response rate [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    NCI sponsored Working Group Guidelines for CLL


Secondary Outcome Measures:
  • Adverse events [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
    Physical examination, blood counts.


Estimated Enrollment: 37
Study Start Date: March 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lenalidomide
Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.
 Drug: Maintenance lenalidomide
Daily maintenance treatment, oral lenalidomide

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Previous induction treatment with bendamustine and rituximab
  • 18 or more years of age
  • chronic lymphocytic leukemia
  • ECOG performance status less than or equal to 2
  • Absolute neutrophile count more than 1,000
  • Platelet count more than 70,000

Exclusion Criteria:

  • Serious medical condition that would prevent treatment with lenalidomide
  • Evidence of tumor lysis syndrome
  • Any prior treatment with lenalidomide
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01465230

Locations
United States, Connecticut
Yale Cancer Center Recruiting
New Haven, Connecticut, United States, 06519
Contact: Molly Daley     203-785-5702     molly.daley@yale.edu    
Contact: Diana Irizarry, RN     203-737-2451     diana.irizarry@yale.edu    
Sponsors and Collaborators
Yale University
Celgene Corporation
Investigators
Principal Investigator: Terri L Parker, MD Yale University
  More Information

No publications provided

Responsible Party: Terri Parker, Assistant Professor, Yale University
ClinicalTrials.gov Identifier: NCT01465230     History of Changes
Other Study ID Numbers: 1105008515
Study First Received: October 28, 2011
Last Updated: January 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
chronic lymphocytic leukemia
maintenance therapy

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bendamustine
Rituximab
Lenalidomide
Thalidomide
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on May 21, 2013