Clinical Trials /

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

NCT02038153

Description:

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.

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Unknown status

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia Who Have Undergone Stem Cell Transplant
  • Official Title: A Phase I/II Study of Lenalidomide Maintenance After Autologous Stem Cell Transplant for Elderly Patients With Acute Myeloid Leukemia (AML)

Clinical Trial IDs

  • ORG STUDY ID: 13-08-148
  • SECONDARY ID: NCI-2013-02493
  • SECONDARY ID: 13-08-148
  • SECONDARY ID: P30CA013330
  • NCT ID: NCT02038153

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

Interventions

DrugSynonymsArms
LenalidomideCC-5013, CC5013, CDC 501, IMiD-1Treatment (lenalidomide)

Purpose

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.

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 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 Arms

NameTypeDescriptionInterventions
Treatment (lenalidomide)ExperimentalPatients receive lenalidomide PO QD on days 1-21. Courses repeat 4 weeks in the absence of disease progression or unacceptable toxicity.
  • Lenalidomide

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

          -  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
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:60 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Relapse free survival rate
Time Frame:2 years
Safety Issue:
Description: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 Outcome Measures

Measure:Overall survival
Time Frame:From transplant until death of any cause, assessed up to 4 years
Safety Issue:
Description:Kaplan-Meier analysis will be conducted.

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Unknown status
Lead Sponsor:Albert Einstein College of Medicine, Inc.

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