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

This study has been terminated.
(This study was unsuccessful in enrolling the target number of subjects during the funding period.)
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01465230
First received: October 28, 2011
Last updated: October 22, 2014
Last verified: October 2014

October 28, 2011
October 22, 2014
March 2012
November 2013   (final data collection date for primary outcome measure)
Response Rate [ Time Frame: 36 months ] [ Designated as safety issue: No ]
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.
Response rate [ Time Frame: 36 months ] [ Designated as safety issue: No ]
NCI sponsored Working Group Guidelines for CLL
Complete list of historical versions of study NCT01465230 on ClinicalTrials.gov Archive Site
Not Provided
Adverse events [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
Physical examination, blood counts.
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.
 
Terminated
2
November 2013
November 2013   (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
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01465230
1105008515
Yes
Yale University
Yale University
Celgene Corporation
Principal Investigator: Terri L Parker, MD Yale University
Yale University
October 2014

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