Lenalidomide in Acute Leukemias and Chronic Lymphocytic Leukemia.
Completed · Phase 1
Conditions studied: Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Lymphocytic Leukemia
In brief
Phase I Study of Lenalidomide in Acute Leukemias and Chronic Lymphocytic Leukemia.
Key facts
- Study ID
- NCT00466895
- Run by
- Leslie Andritsos
- People needed
- 37
- Starts
- 2007-04-01
- Expected to finish
- 2016-07-01
- Last updated by the study team
- 2017-11-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Ohio State University Medical Center — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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