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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Chronic Lymphocytic Leukemia, Leukemia, B-Cell, Chronic

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Trial Information

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


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)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety

Outcome Time Frame:

February 2010

Safety Issue:

Yes

Principal Investigator

Elayne Lombardy, MD

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation

Authority:

United States: Food and Drug Administration

Study ID:

CC-5013-CLL-001

NCT ID:

NCT00419250

Start Date:

December 2006

Completion Date:

June 2010

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Leukemia, B-Cell, Chronic
  • relapsed
  • refractory
  • fludarabine
  • Revlimid
  • lenalidomide
  • CLL
  • B-cell CLL
  • CC-5013
  • Chronic Lymphocytic Leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Leukemia, B-Cell

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
Roswell Park Cancer InstituteBuffalo, New York  14263
Swedish Cancer InstituteSeattle, Washington  98104
Mountain States Tumor InstituteBoise, Idaho  83712
Alta Bates Summit Comprehensive Cancer CenterBerkeley, California  94704
University of Chicago Medical CenterChicago, Illinois  60637
Indiana University Medical CenterIndianapolis, Indiana  46202
University of Texas MD Anderson Cancer CenterHouston, Texas  77030
The Cleveland Clinic FoundationCleveland, Ohio  
Wake Forest University School of MedicineWinston-Salem, North Carolina  27157-1023
Desert Hematology Oncology Medical Group, Inc.Rancho Mirage, California  92270
Cancer & Blood Disease CenterLecanto, Florida  34461
Baptist Cancer InstituteJacksonville, Florida  32207
Robert H. Lurie Comprehensive Cancer CenterChicago, Illinois  60611
SUNY Upstate Medical CenterSyracuse, New York  13210
Northwest Georgia Oncology Centers, PC., Wellstar Health SystemMarietta, Georgia  30060
LSU Health Sciences Center, Feist-Weiller Cancer CenterShreveport, Louisiana  71130
Karmanos Cancer Institute/Wayne State University School of MedicineDetroit, Michigan  48201
Weill Medical College of Cornell University, Division of Hematology & OncologyNew York, New York  10021
Abington Hematology Oncology Assoc., Inc.Willow Grove, Pennsylvania  19090