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Phase I Study of Lenalidomide in Acute Leukemias and Chronic Lymphocytic Leukemia.

Phase 1
18 Years
Open (Enrolling)
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Lymphocytic Leukemia

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Trial Information

Phase I Study of Lenalidomide in Acute Leukemias and Chronic Lymphocytic Leukemia.

Inclusion Criteria:

- 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 performance status 0-2.

- Patients with CNS involvement will be considered eligible for this study if no
residual leukemic cells are detected in the CSF following intrathecal chemotherapy or

Exclusion Criteria:

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerable dose

Outcome Time Frame:

Every 2 weeks during cycle 1; Monthly during subsequent cycles

Safety Issue:


Principal Investigator

William Blum, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University


United States: Food and Drug Administration

Study ID:




Start Date:

April 2007

Completion Date:

Related Keywords:

  • Acute Myeloid Leukemia
  • Acute Lymphoblastic Leukemia
  • Chronic Lymphocytic Leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid



Ohio State University Columbus, Ohio  43210