Status:
COMPLETED
Lenalidomide in Acute Leukemias and Chronic Lymphocytic Leukemia.
Lead Sponsor:
Leslie Andritsos
Collaborating Sponsors:
Celgene Corporation
Conditions:
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Phase I Study of Lenalidomide in Acute Leukemias and Chronic Lymphocytic Leukemia.
Detailed Description
Rationale: Lenalidomide has properties of thalidomide and appears to have some activity against cancer in laboratory tests. Researchers are still learning how lenalidomide works against cancer in pat...
Eligibility Criteria
Inclusion
- Blood blast count must be \< 40,000/uL prior to initiation of therapy. Hydroxyurea (up to 6g/day) may be administered prior to initiation of therapy and during the first week to maintain blood blast count \< 40,000/uL
- ECOG(Eastern Cooperative Oncology Group)performance status 0-2.
- Patients with CNS(central nervous system)involvement will be considered eligible for this study if no residual leukemic cells are detected in the CSF (cerebrospinal fluid)following intrathecal chemotherapy or radiation.
Exclusion
- Patients with acute promyelocytic leukemia are excluded unless patient has failed salvage therapy with arsenic.
- Patients with HIV are excluded due to increased risk of infectious complications, marrow suppression, and potential interactions with antiviral therapy.
- CLL patients who have had chemotherapy (with the exception of hydroxyurea) or radiotherapy within 4 weeks prior to entering the study are excluded. CLL patients receiving corticosteroids (within 2 weeks) for treatment of disease (other than autoimmune manifestations of CLL) are not eligible.
- Patients who have received mitomycin C or nitrosourea require a six weeks recovery period before they can be enrolled on the current study.
- Patients with the following abnormal clinical values are excluded (unless abnormalities in these parameters are directly attributable to malignancy): Serum creatinine \>2.0 mg/dl Total bilirubin \> 2 x upper limit of normal (unless due to Gilbert's syndrome) ALT and AST \> 5 x upper limit of normal
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00466895
Start Date
April 1 2007
End Date
July 1 2016
Last Update
November 14 2017
Active Locations (1)
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1
Ohio State University Medical Center
Columbus, Ohio, United States, 43210