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
18 Years
N/A
Not Enrolling
Both
Chronic Lymphocytic Leukemia, Leukemia, B-Cell, Chronic
Both
Chronic Lymphocytic Leukemia, Leukemia, B-Cell, Chronic
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 Center | Tucson, Arizona 85724 |
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| Swedish Cancer Institute | Seattle, Washington 98104 |
| Mountain States Tumor Institute | Boise, Idaho 83712 |
| Alta Bates Summit Comprehensive Cancer Center | Berkeley, California 94704 |
| University of Chicago Medical Center | Chicago, Illinois 60637 |
| Indiana University Medical Center | Indianapolis, Indiana 46202 |
| University of Texas MD Anderson Cancer Center | Houston, Texas 77030 |
| The Cleveland Clinic Foundation | Cleveland, Ohio |
| Wake Forest University School of Medicine | Winston-Salem, North Carolina 27157-1023 |
| Desert Hematology Oncology Medical Group, Inc. | Rancho Mirage, California 92270 |
| Cancer & Blood Disease Center | Lecanto, Florida 34461 |
| Baptist Cancer Institute | Jacksonville, Florida 32207 |
| Robert H. Lurie Comprehensive Cancer Center | Chicago, Illinois 60611 |
| SUNY Upstate Medical Center | Syracuse, New York 13210 |
| Northwest Georgia Oncology Centers, PC., Wellstar Health System | Marietta, Georgia 30060 |
| LSU Health Sciences Center, Feist-Weiller Cancer Center | Shreveport, Louisiana 71130 |
| Karmanos Cancer Institute/Wayne State University School of Medicine | Detroit, Michigan 48201 |
| Weill Medical College of Cornell University, Division of Hematology & Oncology | New York, New York 10021 |
| Abington Hematology Oncology Assoc., Inc. | Willow Grove, Pennsylvania 19090 |
