Adult Acute Myeloid Leukemia in Remission Clinical Trial
Official title:
A Phase I/II Study of Lenalidomide Maintenance After Autologous Stem Cell Transplant for Elderly Patients With Acute Myeloid Leukemia (AML)
This phase I/II trial studies the side effects and best dose of lenalidomide and how well it works in treating older patients with acute myeloid leukemia (AML) who have undergone stem cell transplant. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing.
PRIMARY OBJECTIVES:
I. To determine the safety and efficacy of maintenance lenalidomide post autologous
peripheral blood stem cell transplantation (PBSCT) for elderly patients with AML (AML).
SECONDARY OBJECTIVES:
I. To define maximum tolerated dose (MTD) and establish therapeutic dose level (TDL) of
lenalidomide given post autologous transplant for AML.
II. To determine the progression free survival for patients treated with this approach.
III. To determine the overall survival for patients treated with this approach. IV. To
determine the role of residual AML stem cells on efficacy of lenalidomide maintenance after
autologous PBSCT.
OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.
Patients receive lenalidomide orally (PO) once daily (QD) on days 1-21. Courses repeat 4
weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and then every 6
months thereafter.
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