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

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
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
Primary Completion Date : November 2013
Study Completion Date : November 2013


Arms and Interventions

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


Outcome Measures

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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01465230     History of Changes
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:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Lenalidomide
Rituximab
Thalidomide
Bendamustine Hydrochloride
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action