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

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01465230
• Other study ID #: 1105008515
• Status: Terminated
• Phase: Phase 2
• First received: October 28, 2011
• Last updated: October 22, 2014
• Start date: March 2012
• Est. completion date: November 2013

Study information

• Verified date: October 2014
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• Maintenance lenalidomide
Daily maintenance treatment, oral lenalidomide

Locations

Country	Name	City	State
United States	Yale Cancer Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Celgene Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate	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.	36 months	No