RECRUITING

Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)

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Conditions

Acute Myeloid LeukemiaVenetoclaxGemtuzumab OzogamicinFludarabineCytarabineRelapsed refractoryAzacitidine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A study to evaluate if the randomized addition of venetoclax to a chemotherapy backbone (fludarabine/cytarabine/gemtuzumab ozogamicin \[GO\]) improves survival of children/adolescents/young adults with acute myeloid leukemia (AML) in 1st relapse who are unable to receive additional anthracyclines, or in 2nd relapse.

Official Title

A Randomized Phase 3 Trial of Fludarabine/Cytarabine/Gemtuzumab Ozogamicin With or Without Venetoclax in Children With Relapsed AML

Quick Facts

Study Start:2022-10-01
Study Completion:2032-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05183035

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:29 Days to 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Gwen Nichols, MD
CONTACT
914-821-8217
gwen.nichols@lls.org
Michel Zwaan
CONTACT
+31 88 972 5206
c.m.zwaan@prinsesmaximacentrum.nl

Principal Investigator

Seth Karol, MD
PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Marlous Bakker
STUDY_DIRECTOR
Princess Maxima Center for Pediatric Oncology

Study Locations (Sites)

Phoenix Children's Hospital
Phoenix, Arizona, 85016
United States
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
United States
MemorialCare Miller Children's and Women's Hospital Long Beach
Long Beach, California, 90806
United States
Children's Hospital of Orange County Main Campus - Orange
Orange, California, 92868
United States
Benioff Children's Hospital - Mission Bay
San Francisco, California, 94158
United States
Children's Hospital Colorado
Aurora, Colorado, 80045
United States
Yale University
New Haven, Connecticut, 06511
United States
Nemours Alfred I. Dupont Hospital for Children
Wilmington, Delaware, 19803
United States
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908
United States
Nemours Children's Specialty Care Jacksonville
Jacksonville, Florida, 32207
United States
Nemours Children's Hospital - Orlando
Orlando, Florida, 32827
United States
Saint Joseph's Hospital - Tampa
Tampa, Florida, 33607
United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
United States
Kapi'olani Medical Center for Women and Children
Honolulu, Hawaii, 96826
United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
United States
Comer Children's Hospital
Chicago, Illinois, 60637
United States
University of Iowa Stead Family Children's Hospital
Iowa City, Iowa, 52242
United States
Norton Children's Hospital
Louisville, Kentucky, 40202
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Children's Hospital of Michigan
Detroit, Michigan, 48201
United States
Masonic Cancer Center
Minneapolis, Minnesota, 55455
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216
United States
The Children's Mercy Hospital - Adele Hall Campus
Kansas City, Missouri, 64108
United States
Washington University School of Medicine in St. Louis
Saint Louis, Missouri, 63110
United States
Alliance for Childhood Diseases dba Cure 4 The Kids Foundation
Las Vegas, Nevada, 89135
United States
Morristown Medical Center
Morristown, New Jersey, 07960
United States
Columbia University Irving Medical Center
New York, New York, 10032
United States
Memorial Sloan Kettering Cancer Center - New York
New York, New York, 10065
United States
Cohen Children's Medical Center
Queens, New York, 11040
United States
Nationwide Children's Hospital
Columbus, Ohio, 43205
United States
Doernbecher Children's Hospital
Portland, Oregon, 97239
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Prisma Health Richland Hospital
Columbia, South Carolina, 29203
United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105-3678
United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
United States
Harold C. Simmons Comprehensive Cancer Center
Dallas, Texas, 75235
United States
Texas Children's Hospital
Houston, Texas, 77030
United States
Primary Children's Hospital
Salt Lake City, Utah, 84113
United States
Seattle Children's Hospital
Seattle, Washington, 98105
United States

Collaborators and Investigators

Sponsor: LLS PedAL Initiative, LLC

  • Seth Karol, MD, PRINCIPAL_INVESTIGATOR, St. Jude Children's Research Hospital
  • Marlous Bakker, STUDY_DIRECTOR, Princess Maxima Center for Pediatric Oncology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-01
Study Completion Date2032-02

Study Record Updates

Study Start Date2022-10-01
Study Completion Date2032-02

Terms related to this study

Keywords Provided by Researchers

  • Venetoclax
  • Gemtuzumab Ozogamicin
  • Fludarabine
  • Cytarabine
  • Relapsed refractory
  • Azacitidine

Additional Relevant MeSH Terms

  • Acute Myeloid Leukemia