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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Albert Einstein College of Medicine of Yeshiva University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ira Braunschweig, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT02038153
First received: January 15, 2014
Last updated: March 2, 2015
Last verified: March 2015
  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.


Condition Intervention Phase
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
Drug: Lenalidomide
Other: Laboratory Biomarker Analysis
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Lenalidomide Maintenance After Autologous Stem Cell Transplant for Elderly Patients With Acute Myeloid Leukemia (AML)

Resource links provided by NLM:


Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

Primary Outcome Measures:
  • Relapse free survival rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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:
  • Overall survival [ Time Frame: From transplant until death of any cause, assessed up to 4 years ] [ Designated as safety issue: No ]
    Kaplan-Meier analysis will be conducted.


Estimated Enrollment: 48
Study Start Date: December 2013
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (lenalidomide)
Patients receive lenalidomide PO QD on days 1-21. Courses repeat 4 weeks in the absence of disease progression or unacceptable toxicity.
Drug: Lenalidomide
Given PO
Other Names:
  • CC-5013
  • CC5013
  • CDC 501
  • IMiD-1
Other: Laboratory Biomarker Analysis
Correlative studies

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.

  Eligibility

Ages Eligible for Study:   60 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02038153

Locations
United States, New York
Albert Einstein College of Medicine Recruiting
Bronx, New York, United States, 10461
Contact: Ira Braunschweig    718-920-4826    ibraunsc@montefiore.org   
Principal Investigator: Ira Braunschweig         
Montefiore Medical Center - Moses Campus Recruiting
Bronx, New York, United States, 10467-2490
Contact: Ira Braunschweig    718-920-4826    ibraunsc@montefiore.org   
Principal Investigator: Ira Braunschweig         
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
Investigators
Principal Investigator: Ira Braunschweig Albert Einstein College of Medicine of Yeshiva University
  More Information

No publications provided

Responsible Party: Ira Braunschweig, Principal Investigator, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier: NCT02038153     History of Changes
Other Study ID Numbers: 13-08-148, NCI-2013-02493, 13-08-148, P30CA013330
Study First Received: January 15, 2014
Last Updated: March 2, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Leukemia, Myeloid, Acute
Leukemia
Leukemia, Erythroblastic, Acute
Leukemia, Megakaryoblastic, Acute
Leukemia, Monocytic, Acute
Leukemia, Myeloid
Leukemia, Myelomonocytic, Acute
Leukemia, Myelomonocytic, Chronic
Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases
Hematologic Diseases
Myelodysplastic-Myeloproliferative Diseases
Myeloproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Precancerous Conditions
Lenalidomide
Thalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 29, 2015