A Dose Escalation Study of Lenalidomide in Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia - Full Text View

Sponsored by:	Celgene Corporation
Information provided by:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00419250

Purpose

Phase 1: The purpose of this study segment 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.

Phase 2: The purpose of this study segment is to evaluate the safety and efficacy of the lenalidomide MTEDL administered by a continuous daily regimen versus a cyclic regimen, after an initial stepwise dose-escalation in subjects with relapsed or refractory B-cell CLL.

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

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Fludarabine Fludarabine monophosphate Lenalidomide CC 5013

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase 1/2, 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

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:

Safety [ Time Frame: June 2010 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Response [ Time Frame: March 2011 ] [ Designated as safety issue: No ]
Duration of response [ Time Frame: March 2011 ] [ Designated as safety issue: No ]
Time to response [ Time Frame: March 2011 ] [ Designated as safety issue: No ]
Progression free survival [ Time Frame: March 2011 ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: March 2011 ] [ Designated as safety issue: No ]
Absolute lymphocyte count [ Time Frame: March 2011 ] [ Designated as safety issue: No ]
Evaluation of minimal residual disease (MRD) by flow cytometry [ Time Frame: March 2011 ] [ Designated as safety issue: No ]

Estimated Enrollment:	124
Study Start Date:	December 2006
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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 25 Study Locations

Sponsors and Collaborators

Celgene Corporation

Investigators

Study Director:	Laure de Parseval, MD	Celgene Corporation
Principal Investigator:	Asher Chanan-Khan, MD	Roswell Park Cancer Institute

More Information

Responsible Party:	Celgene ( Laure de Parseval, MD )
Study ID Numbers:	CC-5013-CLL-001
Study First Received:	January 5, 2007
Last Updated:	May 13, 2008
ClinicalTrials.gov Identifier:	NCT00419250
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

Study placed in the following topic categories:

Chronic lymphocytic leukemia
Lymphatic Diseases
Leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders
Leukemia, Lymphocytic, Chronic, B-Cell

Leukemia, B-cell, chronic
Lenalidomide
Fludarabine
Fludarabine monophosphate
Lymphoproliferative Disorders
Leukemia, B-Cell

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009