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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:
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00419250
First received: January 5, 2007
Last updated: January 17, 2011
Last verified: January 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Lymphocytic Leukemia
Leukemia, B-Cell, Chronic
 Drug: lenalidomide
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Safety [ Time Frame: February 2010 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 52
Study Start Date: December 2006
Study Completion Date: June 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: lenalidomide
    The brand name is Revlimid.
    Other Name: The brand name is Revlimid.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00419250

  Show 35 Study Locations
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Elayne Lombardy, MD Celgene Corporation
Principal Investigator: Asher Chanan-Khan, MD Roswell Park Cancer Institute
  More Information

No publications provided

Responsible Party: Elyane Lombardy, MD, Celgene
ClinicalTrials.gov Identifier: NCT00419250     History of Changes
Other Study ID Numbers: CC-5013-CLL-001
Study First Received: January 5, 2007
Last Updated: January 17, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
relapsed
refractory
fludarabine
Revlimid
lenalidomide
 CLL
B-cell CLL
CC-5013
Chronic Lymphocytic Leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Leukemia, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lenalidomide
Thalidomide
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on June 18, 2013