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

This study is currently recruiting participants.
Verified January 2013 by Yale University
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Terri Parker, Yale University
ClinicalTrials.gov Identifier:
NCT01465230
First received: October 28, 2011
Last updated: January 14, 2013
Last verified: January 2013

October 28, 2011
January 14, 2013
March 2012
March 2015   (final data collection date for primary outcome measure)
Response rate [ Time Frame: 36 months ] [ Designated as safety issue: No ]
NCI sponsored Working Group Guidelines for CLL
Same as current
Complete list of historical versions of study NCT01465230 on ClinicalTrials.gov Archive Site
Adverse events [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
Physical examination, blood counts.
Same as current
Not Provided
Not Provided
 
Maintenance Therapy: Lenalidomide Following Bendamustine and Rituximab Induction Therapy for Chronic Lymphocytic Leukemia
Maintenance Therapy With Lenalidomide Following Bendamustine and Rituximab Induction Therapy for Chronic Lymphocytic Leukemia

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).

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Lymphocytic Leukemia
Drug: Maintenance lenalidomide
Daily maintenance treatment, oral lenalidomide
Experimental: lenalidomide
Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.
Intervention: Drug: Maintenance lenalidomide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
37
March 2016
March 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Not Provided
United States
 
NCT01465230
1105008515
Yes
Terri Parker, Yale University
Yale University
Celgene Corporation
Principal Investigator: Terri L Parker, MD Yale University
Yale University
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP