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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Correlative studies
Given PO
Albert Einstein College of Medicine
The Bronx, New York, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States
Relapse Free Survival Rate
The Relapse free survival rate is defined as the Leukemia free survival rate during the first two years after and during the initiation of treatment . The observed relapse free survival rate will be calculated along with its 95% confidence interval. A one sample test on proportion will be used to detect if the relapse free survival rate with lenalidomide is significantly higher than that without the treatment (relapse rate is expected to be \> 95%).
Time frame: initial 2 years after treatment begins
Overall Survival
Kaplan-Meier analysis will be conducted.
Time frame: From transplant until death of any cause, assessed up to 5 years
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