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Lenalidomide and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Recurrent Adult Acute Myeloid Leukemia Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial Description

PRIMARY OBJECTIVES:

I. Determine the maximum tolerated dose (MTD) of lenalidomide following intermediate dose ARA-C (cytarabine) in relapsed/refractory AML.

SECONDARY OBJECTIVES:

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. ;

Study Design

Related Conditions & MeSH terms

  • 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)
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myeloid, Acute
  • Recurrent Adult Acute Myeloid Leukemia
Clinical Trial Details
NCT number NCT01246622
Study type Interventional
Source Roswell Park Cancer Institute
Contact
Status Completed
Phase Phase 1
Start date February 7, 2011
Completion date June 5, 2019
View Details
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