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A Dose Escalation Study of Lenalidomide in Relapsed or Refractory B-cell Chronic Lymphocytic Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00419250
First received: January 5, 2007
Last updated: August 26, 2013
Last verified: August 2013

January 5, 2007
August 26, 2013
December 2006
February 2010   (final data collection date for primary outcome measure)
Safety [ Time Frame: February 2010 ] [ Designated as safety issue: Yes ]
Response
Complete list of historical versions of study NCT00419250 on ClinicalTrials.gov Archive Site
  • Response [ Time Frame: February 2010 ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: February 2010 ] [ Designated as safety issue: No ]
  • Time to response [ Time Frame: February 2010 ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: February 2010 ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: February 2010 ] [ Designated as safety issue: No ]
  • Absolute lymphocyte count [ Time Frame: February 2010 ] [ Designated as safety issue: No ]
  • Evaluation of minimal residual disease (MRD) by flow cytometry [ Time Frame: February 2010 ] [ Designated as safety issue: No ]
  • Duration of response
  • Time to response
  • Survival
  • Safety
Not Provided
Not Provided
 
A Dose Escalation Study of Lenalidomide in Relapsed or Refractory B-cell Chronic Lymphocytic Leukemia
A Phase 1, Multi-center, Open-label Study of the Safety and Efficacy of a Stepwise Dose-escalation Schedule of Lenalidomide Monotherapy in Subjects With Relapsed or Refractory B-cell Chronic Lymphocytic Leukemia

The purpose of this study is to evaluate the safety of lenalidomide and to define the maximum tolerated escalation dose level (MTEDL) when administered by a stepwise dose-escalation schedule in subjects with relapsed or refractory B-cell CLL.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Lymphocytic Leukemia
  • Leukemia, B-Cell, Chronic
Drug: lenalidomide
Other Name: Revlimid, CC-5013
  • Experimental: dose-escalation to 5 mg lenalidomide (len)
    escalate up to 5 mg once daily / 28-day cycle
    Intervention: Drug: lenalidomide
  • Experimental: dose-escalation to 10 mg lenalidomide (len)
    escalate up to 10 mg once daily / 28-day cycle
    Intervention: Drug: lenalidomide
  • Experimental: dose-escalation to 15 mg lenalidomide (len)
    escalate up to 15 mg once daily / 28-day cycle
    Intervention: Drug: lenalidomide
  • Experimental: dose-escalation to 20 mg lenalidomide (len)
    escalate up to 20 mg once daily / 28-day cycle
    Intervention: Drug: lenalidomide
  • Experimental: dose-escalation to 25 mg lenalidomide (len)
    escalate up to 25 mg once daily / 28-day cycle
    Intervention: Drug: lenalidomide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
June 2010
February 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Documented diagnosis of B-cell CLL that has relapsed after or is refractory to at least one prior regimen. The prior regimen(s) must have included an alkylating agent and fludarabine (used in combination or separately)
  • ECOG < or = 2
  • Willing to agree to follow the pregnancy precautions.

Exclusion Criteria:

  • Pregnant or nursing women
  • Systemic treatment for B-cell CLL within 28 days of study start
  • Central nervous system involvement
  • History of renal failure requiring dialysis
  • Prior treatment with lenalidomide
  • Alemtuzumab therapy within 56 days of initiating lenalidomide treatment
  • ANC < 1000 / ul
  • Platelet count < 50,000 / ul
  • Calculated creatinine clearance < 60 mL/min (Cockroft-Gault method)
  • AST or ALT > 3.0 x upper limit of normal
  • Serum total bilirubin > 2.0 mg/dl
  • Neuropathy > or = Grade 2
  • Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
  • Richter's transformation (active)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Germany,   Italy,   Spain,   Sweden,   United Kingdom
 
NCT00419250
CC-5013-CLL-001
Yes
Celgene Corporation
Celgene Corporation
Not Provided
Study Director: Elayne Lombardy, MD Celgene Corporation
Principal Investigator: Asher Chanan-Khan, MD Roswell Park Cancer Institute
Celgene Corporation
August 2013

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