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

Phase 2

Terminated

• Conditions: Chronic Lymphocytic Leukemia
• Interventions: Drug: Maintenance lenalidomide

• Registration Number: NCT01465230
• Lead Sponsor: 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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-10-28
• Study First Submitted QC: 2011-11-01
• Study First Posted: 2011-11-04
• Study Start: 2012-03
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Results First Submitted: 2014-08-26
• Status Verified: 2014-10
• Results First Submitted QC: 2014-10-22
• Last Update Submitted: 2014-10-22
• Results First Posted: 2014-10-23
• Last Update Posted: 2014-10-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

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Exclusion Criteria

• Serious medical condition that would prevent treatment with lenalidomide
• Evidence of tumor lysis syndrome
• Any prior treatment with lenalidomide

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
lenalidomide	Maintenance lenalidomide	Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.

Primary Outcome Measures

Name	Time	Method
Response Rate	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.

Trial Locations

Locations (1)

Yale Cancer Center; 🇺🇸 New Haven, Connecticut, United States