Spots Global Cancer Trial Database for A Study of Lenalidomide in Pediatric Subjects With Relapsed or Refractory Acute Myeloid Leukemia
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Trial Identification
Brief Title: A Study of Lenalidomide in Pediatric Subjects With Relapsed or Refractory Acute Myeloid Leukemia
Official Title: A Phase 2, Multicenter, Single-arm, Open-label Study to Evaluate the Activity, Safety and Pharmacokinetics of Lenalidomide (Revlimid®) in Pediatric Subjects From 1 to = 18 Years of Age With Relapsed or Refractory Acute Myeloid Leukemia.
Study ID: NCT02538965
Conditions
Interventions
Study Description
Brief Summary: To determine the activity of lenalidomide in the treatment of pediatric subjects with relapsed/refractory acute myeloid leukemia (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 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 participants (18 participants in Stage 1 and an additional 25 participants in Stage 2) are required for assessment of the primary endpoint. To allow for participants 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 participants may be enrolled for a maximum of 47 evaluable subjects across approximately 70 sites. Approximately 50% of enrolled participants 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 participants 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 participants 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.
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Children's Hospital, Birmingham, Alabama, United States
Phoenix Childrens Hospital, Phoenix, Arizona, United States
Arkansas Children's Hospital, Little Rock, Arkansas, United States
Miller Children's Hospital, Long Beach, California, United States
Children's Hospital of Los Angeles, Los Angeles, California, United States
Southern California Permanente Medical Group, Los Angeles, California, United States
Valley Children's Hospital, Madera, California, United States
Children's Hospital of Orange County, Orange, California, United States
Lucile Salter Packard Children's Hospital at Stanford, Palo Alto, California, United States
Loma Linda University, San Bernardino, California, United States
UCSF Children's Hospital, San Francisco, California, United States
Colorado Children's Hospital, Aurora, Colorado, United States
Connecticut Children's Medical Center, Hartford, Connecticut, United States
Alfred I Dupont Hospital For Children, Wilmington, Delaware, United States
Children's Hospital National Medical Center, Washington, District of Columbia, United States
Golisano Children's Hospital of Southwest Florida, Fort Myers, Florida, United States
Nemours Children's Clinic, Jacksonville, Florida, United States
All Children's Hospital, Saint Petersburg, Florida, United States
Children's Healthcare of Atlanta, Atlanta, Georgia, United States
Ann and Robert H Lurie Childrens Hospital of Chicago, Chicago, Illinois, United States
Advocate Chilldren's Hospital, Oak Lawn, Illinois, United States
Riley Hospital For Children at IU Health, Indianapolis, Indiana, United States
Kosair Children's Hospital, Louisville, Kentucky, United States
Children's Hospital New Orleans, New Orleans, Louisiana, United States
Johns Hopkins University, Baltimore, Maryland, United States
University of Michigan, Ann Arbor, Michigan, United States
Children's Hospitals and Clinics of Minnesota, Minneapolis, Minnesota, United States
University of Minnesota, Minneapolis, Minnesota, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Children's Mercy Hospital, Kansas City, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Children's Specialty Center of Nevada, Las Vegas, Nevada, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Morristown Memorial Hosp, Morristown, New Jersey, United States
Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Roswell Park Cancer Inst, Buffalo, New York, United States
Columbia University Medical Center, New York, New York, United States
University of Rochester Medical Center, Rochester, New York, United States
New York Medical College, Valhalla, New York, United States
University of North Carolina, Chapel Hill, North Carolina, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Nationwide Children's Hospital, Columbus, Ohio, United States
Legacy Emanuel Hospital and Health Center, Portland, Oregon, United States
Penn State Milton S Hershey Medical Center, Hershey, Pennsylvania, United States
UPMC Childrens Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States
Carolinas Healthcare System, Charleston, South Carolina, United States
Greenville Health System, Greenville, South Carolina, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
Dell Children's Medical Center of Central Texas, Austin, Texas, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
Texas Children's Cancer Center, Houston, Texas, United States
Methodist Hospital, San Antonio, Texas, United States
Primary Children's Medical Center, Salt Lake City, Utah, United States
Children's Hospital of The King's Daughters, Norfolk, Virginia, United States
Seattle Children's Hospital, Seattle, Washington, United States
Midwest Children's Cancer Center, Milwaukee, Wisconsin, United States
Alberta Childrens Hospital, Calgary, Alberta, Canada
British Columbia Children's Hospital, Vancouver, British Columbia, Canada
IWK Health Center, Halifax, Nova Scotia, Canada
Childrens Hospital of Eastern Ontario, Ottawa, Ontario, Canada
McGill University Health Center, Montreal, Quebec, Canada
Hospital For Sick Children, Torento, , Canada
Contact Details
Name: Bouchra Benettaib, MD
Affiliation: Celgene Corporation
Role: STUDY_DIRECTOR
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