Phase I Trial of Cytarabine and Lenalidomide in Relapsed or Refractory Acute Myeloid Leukemia Patients

This is a phase I trial for patients with relapsed or refractory acute myelogenous leukemia (AML). Study agent is lenalidomide produced by Celgene.
This specific purpose of the study is to:

assess the safety and effectiveness of cytarabine and lenalidomide in treating your AML.
This is a Phase I/II study. A phase I study test the safety and possible effectiveness, determines a safe dose range, and identifies side effects of an investigational drug. Phase II trials are designed to assess how well the drug works, as well as to continue phase I safety assessments.
All subjects in this study will receive cytarabine, 1/5 gm/m2/day over 3 hours on days 1-5 of a 28 days cycle. You will be in the hospital during this time. You will take lenalidomide by mouth for days 6-26 of the 28 day cycle. On days 27 to 28, you will not take any drugs.
If a complete remission (CR) is not achieved, then your doctor may decide to give you a second cycle of induction therapy, called reinduction therapy that will begin at least 28 days after the first cycle of induction therapy.
At the physician's discretion you may continue maintenance treatment with lenalidomide after completing one or two cycles of combination treatments. We will start lenalidomide at a dose of 25 mg daily. Will will treat a group of 3 patients with lenalidomide at the dose level. If there are no severe side effects seen at the dose level, then the next group of 3 patients will receive a higher dose.

Study Number: 

I 179510

Principal Investigator: 
ClinicalTrials.Gov ID: 

To inquire about participating in these studies, call 1-877-ASK-RPCI (1-877-275-7724) or e-mail