Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia Who Have Undergone Stem Cell Transplant

Stopped early · Phase 1/Phase 2

Conditions studied: Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Adult Acute Myeloid Leukemia in Remission

In brief

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.

Key facts

Study ID

NCT02038153

Run by

Albert Einstein College of Medicine

People needed

3

Starts

2013-12-01

Expected to finish

2016-01-01

Last updated by the study team

2020-05-14

Who can join

Age: 60 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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®

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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