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

Yale University1 site in 1 country2 target enrollmentMarch 2012

ConditionsChronic Lymphocytic Leukemia

InterventionsMaintenance lenalidomide

DrugsMaintenance lenalidomide

Overview

Phase: Phase 2
Intervention: Maintenance lenalidomide
Conditions: Chronic Lymphocytic Leukemia
Sponsor: Yale University
Enrollment: 2
Locations: 1
Primary Endpoint: Response Rate
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

March 2012

End Date

November 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Yale University

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

lenalidomide

Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.

Intervention: Maintenance lenalidomide

Outcomes

Primary Outcomes

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.