Last updated on April 2017

A Study of Lenalidomide in Pediatric Subjects With Relapsed or Refractory Acute Myeloid Leukemia


Brief description of study

To determine the activity of lenalidomide in the treatment of pediatric subjects with relapsed/refractory AML (with second or greater relapse or refractory to at least 2 prior induction attempts) measured by morphological complete response defined as either a CR or CRi within the first 4 cycles of treatment.

Detailed Study Description

This is a multicenter, open-label, single-arm, Phase 2, Simon's Optimal two-stage design study, with an Optional Extension Phase (OEP), that will assess the activity, safety and Pharmacokinetics (PK) of lenalidomide in pediatric subjects from 1 to ≤ 18 years of age with second or greater Relapsed or Refractory Acute Myeloid Leukemia (rrAML). A total of 43 evaluable subjects (18 subjects in Stage 1 and an additional 25 subjects in Stage 2) are required for assessment of the primary endpoint. To allow for subjects found to be unevaluable for the primary endpoint due to an incorrect diagnosis, not having a disease assessment post screening, or who discontinued prior to receiving lenalidomide, up to 4 additional subjects may be enrolled for a maximum of 47 evaluable subjects across approximately 70 sites. Approximately 50% of enrolled subjects will be younger than 12 years of age to provide adequate PK data for this age subset. If during Stage 1, at least 3 of 18 subjects achieve a morphologic complete response (either CR or CRi) within the first 4 cycles of study treatment, then the study will proceed to Stage 2; otherwise, the study will be terminated. Similarly, if at the final analysis, at least 8 of 43 evaluable subjects across Stages 1 and 2 achieve a response (CR/CRi) within the first 4 cycles of study treatment, it will be concluded that lenalidomide has sufficient activity in pediatric Acute Myeloid Leukemia (AML) to warrant subsequent study. The optional extension phase (OEP) will allow subjects who demonstrate clinical benefit, as assessed by the Investigator at the completion of 12 cycles of lenalidomide therapy, to continue receiving oral lenalidomide until they meet the criteria for study discontinuation. In the OEP, only safety, dosing, concomitant medications/procedures, and second primary malignancies (SPMs) will be monitored.

Clinical Study Identifier: NCT02538965

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Children's Hospital
Birmingham, AL United States
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Phoenix Childrens Hospital
Phoenix, AZ United States
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Arkansas Children's Hospital
Little Rock, AR United States
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Miller Children's Hospital
Long Beach, CA United States
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Children's Hospital of Los Angeles
Los Angeles, CA United States
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Southern California Permanente Medical Group
Los Angeles, CA United States
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Valley Children's Hospital
Madera, CA United States
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Children's Hospital of Orange County
Orange, CA United States
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Lucile Salter Packard Children's Hospital at Stanford
Palo Alto, CA United States
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Loma Linda University
San Bernardino, CA United States
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UCSF Children's Hospital
San Francisco, CA United States
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Colorado Children's Hospital
Aurora, CO United States
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Connecticut Children's Medical Center
Hartford, CT United States
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Alfred I Dupont Hospital For Children
Wilmington, DE United States
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Children's Hospital National Medical Center
Washington, D.C., United States
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Golisano Children's Hospital of Southwest Florida
Fort Myers, FL United States
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Nemours Children's Clinic
Jacksonville, FL United States
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All Children's Hospital
Saint Petersburg, FL United States
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Children's Healthcare of Atlanta
Atlanta, GA United States
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Ann and Robert H Lurie Childrens Hospital of Chicago
Chicago, IL United States
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Advocate Chilldren's Hospital
Oak Lawn, IL United States
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Riley Hospital For Children at IU Health
Indianapolis, IN United States
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Kosair Children's Hospital
Louisville, KY United States
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Children's Hospital New Orleans
New Orleans, LA United States
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Johns Hopkins University
Baltimore, MD United States
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University of Michigan
Ann Arbor, MI United States
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Children's Hospitals and Clinics of Minnesota
Minneapolis, MN United States
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University of Minnesota
Minneapolis, MN United States
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University of Mississippi Medical Center
Jackson, MS United States
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Children's Mercy Hospital
Kansas City, MO United States
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Washington University School of Medicine
Saint Louis, MO United States
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Children's Specialty Center of Nevada
Las Vegas, NV United States
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Hackensack University Medical Center
Hackensack, NJ United States
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Morristown Memorial Hosp
Morristown, NJ United States
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Cancer Institute of New Jersey
New Brunswick, NJ United States
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Roswell Park Cancer Inst
Buffalo, NY United States
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Columbia University Medical Center
New York, NY United States
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University of Rochester Medical Center
Rochester, NY United States
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New York Medical College
Valhalla, NY United States
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University of North Carolina
Chapel Hill, NC United States
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Cincinnati Children's Hospital Medical Center
Cincinnati, OH United States
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Nationwide Children's Hospital
Columbus, OH United States
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Legacy Emanuel Hospital and Health Center
Portland, OR United States
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Penn State Milton S Hershey Medical Center
Hershey, PA United States
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UPMC Childrens Hospital of Pittsburgh
Pittsburgh, PA United States
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Carolinas Healthcare System
Charleston, SC United States
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Greenville Health System
Greenville, SC United States
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Vanderbilt University Medical Center
Nashville, TN United States
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Dell Children's Medical Center of Central Texas
Austin, TX United States
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University of Texas Southwestern Medical Center
Dallas, TX United States
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Texas Children's Cancer Center
Houston, TX United States
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Methodist Hospital
San Antonio, TX United States
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Primary Children's Medical Center
Salt Lake City, UT United States
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Children's Hospital of The King's Daughters
Norfolk, VA United States
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Seattle Children's Hospital
Seattle, WA United States
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Midwest Children's Cancer Center
Milwaukee, WI United States
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Alberta Childrens Hospital
Calgary, AB Canada
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British Columbia Children's Hospital
Vancouver, BC Canada
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Childrens Hospital of Eastern Ontario
Ottawa, ON Canada
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McGill University Health Center
Montreal, QC Canada
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Hospital For Sick Children
Torento, Canada
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