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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:
ClinicalTrials.gov Identifier:
NCT00419250
First Posted: January 8, 2007
Last Update Posted: October 31, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Celgene Corporation
January 5, 2007
January 8, 2007
October 31, 2016
December 2006
February 2010   (Final data collection date for primary outcome measure)
Safety [ Time Frame: February 2010 ]
Response
Complete list of historical versions of study NCT00419250 on ClinicalTrials.gov Archive Site
  • Response [ Time Frame: February 2010 ]
  • Duration of response [ Time Frame: February 2010 ]
  • Time to response [ Time Frame: February 2010 ]
  • Progression free survival [ Time Frame: February 2010 ]
  • Overall survival [ Time Frame: February 2010 ]
  • Absolute lymphocyte count [ Time Frame: February 2010 ]
  • Evaluation of minimal residual disease (MRD) by flow cytometry [ Time Frame: February 2010 ]
  • 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
Intervention Model: Single Group Assignment
Masking: None (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
Wendtner CM, Hillmen P, Mahadevan D, Bühler A, Uharek L, Coutré S, Frankfurt O, Bloor A, Bosch F, Furman RR, Kimby E, Gribben JG, Gobbi M, Dreisbach L, Hurd DD, Sekeres MA, Ferrajoli A, Shah S, Zhang J, Moutouh-de Parseval L, Hallek M, Heerema NA, Stilgenbauer S, Chanan-Khan AA. Final results of a multicenter phase 1 study of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia. Leuk Lymphoma. 2012 Mar;53(3):417-23. doi: 10.3109/10428194.2011.618232. Epub 2011 Nov 15.

*   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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Germany,   Italy,   Spain,   Sweden,   United Kingdom,   United States
 
 
NCT00419250
CC-5013-CLL-001
Yes
Not Provided
Not Provided
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
October 2016

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