NCT02038153TerminatedPhase 1
A Phase I/II Study of Lenalidomide Maintenance After Autologous Stem Cell Transplant for Elderly Patients With Acute Myeloid Leukemia (AML)
Albert Einstein College of Medicine3 sites in 1 country3 target enrollmentStarted: December 2013Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Enrollment
- 3
- Locations
- 3
- Primary Endpoint
- Relapse Free Survival Rate
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Creatinine < 1.5 X institutional upper limit of normal OR creatinine clearance >= 30 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
- •Able to take aspirin, or warfarin, or low molecular weight heparin as prophylactic anticoagulation
- •Ability to understand and the willingness to sign a written informed consent document
- •Must be registered into the mandatory RevAssist® program and be willing and able to comply with the requirement of RevAssist®
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
- •Active hepatitis B as defined by hepatitis B surface antigen positivity, unless able to start dual anti-hepatitis B (HepB) therapy, or already on dual anti-HepB therapy
- •Patients who are positive for hepatitis B core antibody, but negative for the hepatitis B surface antigen, should be on lamivudine 100 mg daily until at least 3 months post-transplant
- •Patient is positive for human immunodeficiency virus (HIV) or human T-cell lymphotropic virus-1 (HTLV-1)
- •Women of childbearing potential (defined as a sexually mature woman who has not undergone a hysterectomy or who has had menses at any time in the preceding 24 consecutive months)
- •Men who did not agree not to father a child and who refused to use a latex condom during any sexual contact with women of childbearing potential while taking lenalidomide and for 4 weeks after therapy is stopped, even if they have undergone a successful vasectomy
Arms & Interventions
Treatment (lenalidomide)
Experimental
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 (Other)
Treatment (lenalidomide)
Experimental
Patients receive lenalidomide PO QD on days 1-21. Courses repeat 4 weeks in the absence of disease progression or unacceptable toxicity.
Intervention: Lenalidomide (Drug)
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)
Investigators
Ira Braunschweig
Principal Investigator
Albert Einstein College of Medicine
Study Sites (3)
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