This trial is active, not recruiting.

Conditions acute myeloid leukemia arising from previous myelodysplastic syndrome, adult acute megakaryoblastic leukemia, adult acute monoblastic leukemia, adult acute monocytic leukemia, adult acute myeloid leukemia in remission, adult acute myeloid leukemia with inv(16)(p13.1q22); cbfb-myh11, adult acute myeloid leukemia with maturation, adult acute myeloid leukemia with minimal differentiation, adult acute myeloid leukemia with t(16;16)(p13.1;q22); cbfb-myh11, adult acute myeloid leukemia with t(8;21)(q22;q22); runx1-runx1t1, adult acute myeloid leukemia with t(9;11)(p22;q23); mllt3-mll, adult acute myeloid leukemia without maturation, adult acute myelomonocytic leukemia, adult erythroleukemia, adult pure erythroid leukemia, alkylating agent-related acute myeloid leukemia, recurrent adult acute myeloid leukemia
Treatments lenalidomide, laboratory biomarker analysis
Phase phase 1/phase 2
Sponsor Albert Einstein College of Medicine of Yeshiva University
Collaborator National Cancer Institute (NCI)
Start date December 2013
End date January 2016
Trial size 48 participants
Trial identifier NCT02038153, 13-08-148, NCI-2013-02493, P30CA013330


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 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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Patients receive lenalidomide PO QD on days 1-21. Courses repeat 4 weeks in the absence of disease progression or unacceptable toxicity.
lenalidomide CC-5013
Given PO
laboratory biomarker analysis
Correlative studies

Primary Outcomes

Relapse free survival rate
time frame: 2 years

Secondary Outcomes

Overall survival
time frame: From transplant until death of any cause, assessed up to 4 years

Eligibility Criteria

Male or female participants from 60 years up to 75 years old.

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 (CNS) 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 malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ; cancer treated with curative intent < 5 years - 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 (CHF) - 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 (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

Additional Information

Official title A Phase I/II Study of Lenalidomide Maintenance After Autologous Stem Cell Transplant for Elderly Patients With Acute Myeloid Leukemia (AML)
Principal investigator Ira Braunschweig
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 acute myeloid leukemia (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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Albert Einstein College of Medicine of Yeshiva University.
Location data was received from the National Cancer Institute and was last updated in September 2016.