A Phase I/II Study of Lenalidomide Maintenance After Autologous Stem Cell Transplant for Elderly Patients With Acute Myeloid Leukemia (AML)
Overview
- Phase
- Phase 1
- Intervention
- Laboratory Biomarker Analysis
- Conditions
- Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
- Sponsor
- Albert Einstein College of Medicine
- Enrollment
- 3
- Locations
- 3
- Primary Endpoint
- Relapse Free Survival Rate
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Ira Braunschweig
Principal Investigator
Albert Einstein College of Medicine
Eligibility Criteria
Inclusion Criteria
- •Patients must have a confirmed diagnosis of non-M3 AML; antecedent myelodysplastic syndrome (MDS) is acceptable
- •Post autologous stem cell transplant bone marrow biopsy core that is consistent with morphologic remission
- •Must have received induction and consolidation chemotherapy, and autologous stem cell transplant for AML
- •Life expectancy of greater than 12 months
- •Karnofsky performance status 70 or greater
- •Leukocytes \>= 2,000/mcL
- •Absolute neutrophil count \>= 1,000/mcL
- •Platelets \>= 75,000/mcL
- •Total bilirubin =\< 4 X institutional upper limit of normal unless 2nd to Gilbert's disease
- •Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 4 X institutional upper limit of normal
Exclusion Criteria
- •Patient received chemotherapy or radiotherapy within 2 weeks prior to entering the study or has not recovered from adverse events due to agents administered more than 4 weeks earlier
- •Patient received another investigational agent after post autologous stem cell transplant
- •Patient who will be receiving another investigational product during the study
- •Patient who is growth factor or transfusion dependent
- •Patient has central nervous system leukemia
- •History of allergic reactions attributed to thalidomide or lenalidomide
- •History of erythema nodosum, characterized by a desquamating rash while taking thalidomide or similar drugs
- •Prior history of metastatic malignancy
- •Uncontrolled illness including, but not limited to ongoing or active infection, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; patients must not have suffered recent (\< 6 months) myocardial infarction, unstable angina, uncontrolled hypertension, or difficult to control cardiac arrhythmias
- •Evidence of uncontrolled congestive heart failure
Arms & Interventions
Treatment (lenalidomide)
Patients receive lenalidomide PO QD on days 1-21. Courses repeat 4 weeks in the absence of disease progression or unacceptable toxicity.
Intervention: Laboratory Biomarker Analysis
Treatment (lenalidomide)
Patients receive lenalidomide PO QD on days 1-21. Courses repeat 4 weeks in the absence of disease progression or unacceptable toxicity.
Intervention: Lenalidomide
Outcomes
Primary Outcomes
Relapse Free Survival Rate
Time Frame: initial 2 years after treatment begins
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%).
Secondary Outcomes
- Overall Survival(From transplant until death of any cause, assessed up to 5 years)