Lenalidomide and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
This phase I trial is studying the side effects and best dose of lenalidomide when given together with cytarabine in treating patients with relapsed or refractory acute myeloid leukemia (AML). Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with cytarabine may kill more cancer cells
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Del(5q)
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Recurrent Adult Acute Myeloid Leukemia
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Trial of Cytarabine and Lenalidomide in Relapsed or Refractory Acute Myeloid Leukemia Patients|
- MTD of lenalidomide following intermediate dose cytarabine [ Time Frame: Over course 1 ] [ Designated as safety issue: Yes ]Assessed by Cancer Therapy Evaluation Program (CTEP) Version 4 of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
- Overall response rate [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||March 2011|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Experimental: Treatment (biological therapy)
Patients receive lenalidomide PO on days 6-26 and cytarabine IV over 3 hours on days 1-5. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
Other Names:Drug: lenalidomide
I. Determine the maximum tolerated dose (MTD) of lenalidomide following intermediate dose ARA-C (cytarabine) in relapsed/refractory AML.
I. Evaluate immune reconstitution in patients in complete remission (CR) treated at the MTD.
II. Evaluate the efficacy of the regimen in the expanded group treated at the MTD.
OUTLINE: This is a dose-escalation study of lenalidomide.
Patients receive lenalidomide orally (PO) on days 6-26 and cytarabine intravenously (IV) over 3 hours on days 1-5. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 2 weeks and then every 3 months thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01246622
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|Principal Investigator:||Wetzler Meir||Roswell Park Cancer Institute|