NCT01465230TerminatedPhase 2
Maintenance Therapy With Lenalidomide Following Bendamustine and Rituximab Induction Therapy for Chronic Lymphocytic Leukemia
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Yale University
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Response Rate
Study 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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
lenalidomide
Experimental
Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.
Intervention: Maintenance lenalidomide (Drug)
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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