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

NCT02038153 | Terminated Phase 1 Results DMC

• 3 other identifiers: 13-08-148NCI-2013-02493P30CA013330
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 3

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.

Conditions

Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome; Adult Acute Myeloid Leukemia in Remission

Outcome Measures

Primary Outcomes (1)

• Relapse Free Survival Rate

  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%).

  initial 2 years after treatment begins

Secondary Outcomes (1)

• Overall Survival

  From transplant until death of any cause, assessed up to 5 years

Study Arms (1)

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.

Other: Laboratory Biomarker Analysis; Drug: Lenalidomide

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (lenalidomide)

Lenalidomide DRUG

Given PO

Also known as: CC-5013, CC5013, CDC 501, Revlimid

Treatment (lenalidomide)

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467-2490, United States

Location

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Interventions

Lenalidomide

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Ira Braunschweig
• Organization: Montefiore

ibraunsc@montefiore.org

718 920-4826

Study Officials

• Ira Braunschweig

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 15, 2014
• First Posted: January 16, 2014
• Study Start: December 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2016
• Last Updated: May 14, 2020
• Results First Posted: May 14, 2020

Record last verified: 2020-05

Locations

US (3)