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

This study has been terminated.
(This study was unsuccessful in enrolling the target number of subjects during the funding period.)
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01465230
First received: October 28, 2011
Last updated: October 22, 2014
Last verified: October 2014
  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:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Response Rate [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.


Enrollment: 2
Study Start Date: March 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (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
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: NCT01465230

Locations
United States, Connecticut
Yale Cancer Center
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Celgene Corporation
Investigators
Principal Investigator: Terri L Parker, MD Yale University
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01465230     History of Changes
Other Study ID Numbers: 1105008515
Study First Received: October 28, 2011
Results First Received: August 26, 2014
Last Updated: October 22, 2014
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
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Bendamustine
Lenalidomide
Rituximab
Thalidomide
Alkylating Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014