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
  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: Allocation: Randomized
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:


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)
Arms Assigned Interventions
Experimental: dose-escalation to 5 mg lenalidomide (len)
escalate up to 5 mg once daily / 28-day cycle
Drug: lenalidomide
Other Name: Revlimid, CC-5013
Experimental: dose-escalation to 10 mg lenalidomide (len)
escalate up to 10 mg once daily / 28-day cycle
Drug: lenalidomide
Other Name: Revlimid, CC-5013
Experimental: dose-escalation to 15 mg lenalidomide (len)
escalate up to 15 mg once daily / 28-day cycle
Drug: lenalidomide
Other Name: Revlimid, CC-5013
Experimental: dose-escalation to 20 mg lenalidomide (len)
escalate up to 20 mg once daily / 28-day cycle
Drug: lenalidomide
Other Name: Revlimid, CC-5013
Experimental: dose-escalation to 25 mg lenalidomide (len)
escalate up to 25 mg once daily / 28-day cycle
Drug: lenalidomide
Other Name: Revlimid, CC-5013

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00419250     History of Changes
Other Study ID Numbers: CC-5013-CLL-001
Study First Received: January 5, 2007
Last Updated: August 26, 2013
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, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia
Leukemia, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lenalidomide
Thalidomide
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on October 19, 2014