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

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. Identifier: NCT01465230
Recruitment Status : Terminated (This study was unsuccessful in enrolling the target number of subjects during the funding period.)
First Posted : November 4, 2011
Results First Posted : October 23, 2014
Last Update Posted : October 23, 2014
Celgene Corporation
Information provided by (Responsible Party):
Yale University

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: Maintenance lenalidomide Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Maintenance Therapy With Lenalidomide Following Bendamustine and Rituximab Induction Therapy for Chronic Lymphocytic Leukemia
Study Start Date : March 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Arm Intervention/treatment
Experimental: lenalidomide
Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.
Drug: Maintenance lenalidomide
Daily maintenance treatment, oral lenalidomide

Primary Outcome Measures :
  1. Response Rate [ Time Frame: 36 months ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01465230

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United States, Connecticut
Yale Cancer Center
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Celgene Corporation
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Principal Investigator: Terri L Parker, MD Yale University
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Responsible Party: Yale University Identifier: NCT01465230    
Other Study ID Numbers: 1105008515
First Posted: November 4, 2011    Key Record Dates
Results First Posted: October 23, 2014
Last Update Posted: October 23, 2014
Last Verified: October 2014
Keywords provided by Yale University:
chronic lymphocytic leukemia
maintenance therapy
Additional relevant MeSH terms:
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Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents