Overview

This trial is active, not recruiting.

Conditions acute myeloid leukemia, acute lymphoblastic leukemia, chronic lymphocytic leukemia
Treatment lenalidomide
Phase phase 1
Sponsor Leslie Andritsos
Collaborator Celgene Corporation
Start date April 2007
End date December 2014
Trial size 37 participants
Trial identifier NCT00466895, NCI-2011-03218, OSU-06003

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients must have a diagnosis of Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia(ALL)according to the WHO (World Health Organization) classification.
lenalidomide Revlimid
Dose level -1: 2.5 mg daily for days 1-7, 2.5 mg daily for days 8-21. Dose level 1: 2.5 mg daily for days 1-7, 5 mg daily for days 8-21. Dose level 2: 2.5 mg daily for days 1-7, 7.5 mg daily for days 8-21. Dose level 3: 2.5 mg daily for days 1-7, 10 mg daily for days 8-21. Dose level 4: 2.5 mg daily for days 1-7, 15 mg daily for days 8-21
(Experimental)
Patients must have diagnosis of B-Cell, Chronic Lymphocytic Leukemia(CLL) or Small Lymphocytic Leukemia (SLL) (including Waldenstrom's Macroglobulinemia) requiring therapy (see eligibility criteria for definition of this) and have previously received treatment with one or more prior chemotherapy regimens.
lenalidomide Revlimid
Dose level -1: 2.5 mg daily for days 1-7, 2.5 mg daily for days 8-21. Dose level 1: 2.5 mg daily for days 1-7, 5 mg daily for days 8-21. Dose level 2: 2.5 mg daily for days 1-7, 7.5 mg daily for days 8-21. Dose level 3: 2.5 mg daily for days 1-7, 10 mg daily for days 8-21. Dose level 4: 2.5 mg daily for days 1-7, 15 mg daily for days 8-21

Primary Outcomes

Measure
Maximum tolerable dose
time frame: Every 2 weeks during cycle 1; Monthly during subsequent cycles
Toxicities of lenalidomide
time frame: Every 2 weeks during cycle 1; Monthly for subsequent cycles

Secondary Outcomes

Measure
preliminary clinical activity
time frame: Twice weekly during cycle 1; Weekly during cycles 2-6; Monthly thereafter
plasma and cellular pharmacokinetics
time frame: Days 1, 8, 15 and 21 of first cycle.
pharmacodynamics
time frame: Days 1, 8 and 26.

Eligibility Criteria

Male or female participants at least 18 years old.

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(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 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

Additional Information

Official title Phase I Study of Lenalidomide in Acute Leukemias and Chronic Lymphocytic Leukemia.
Principal investigator Leslie Andritsos, MD
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 patients. Some ways that this drug seems to produce anti-cancer effects include through stimulating the immune system and blocking blood vessels contributing to cancer growth. The current study will explore different dose levels in patients to gather more information about lenalidomide. Purpose: This study will assess the maximum tolerated dose of lenalidomide in patients with relapsed or refractory acute leukemias and chronic lymphocytic leukemias. Toxicity or side effects within patients will also be evaluated. Other purposes of this study include analyzing preliminary clinical activity, pharmacokinetics, and pharmacodynamics. Pharmacokinetics refers to the activity of drugs in the body over a period of time, including how drugs are absorbed, distributed, localized in tissues, and excreted. Pharmacodynamics refers to the bodily processes that lead the drug to effect cancer and other cellular components in the body. Treatment: Study participants will be given lenalidomide through intravenous infusions once every 28 days. A 28-day period constitutes a cycle. Since this study will assess the maximum tolerated dose of lenalidomide, some study participants will receive different amounts of this drug compared to others depending upon when each individual enrolls in the study. Each group of 3 to 6 study participants will receive a higher dose of lenalidomide until the maximum tolerated dose is established. Several tests will be performed throughout the study, including bone marrow biopsies. Imaging exams will be conducted as well. Treatments will be discontinued due to disease growth or intolerable adverse effects. Lenalidomide administration will be repeated for 12 or more cycles in patients that experience clinical benefit.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center.