Phase
Condition
Leukemia
Acute Myeloid Leukemia
Platelet Disorders
Treatment
Etoposide
Cytarabine
Quizartinib
Clinical Study ID
Ages 1-21 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants must meet all of the following criteria to be eligible for enrollment into the study:
Has diagnosis of AML according to the World Health Organization (WHO) 2008classification with ≥5% blasts in bone marrow, with or without extramedullarydisease
In first relapse or refractory to first-line high-dose chemotherapy with no morethan 1 attempt (1 to 2 cycles of induction chemotherapy) at remission induction -prior HSCT is permitted
Has presence of the FLT3-ITD activating mutation in bone marrow or peripheral bloodas defined in the protocol
Is between 1 month and 21 years of age at the time the Informed Consent/Assent formis signed
Has protocol-defined adequate performance status score
Has fully recovered from the acute clinically significant toxicity effects of allprior chemotherapy, immunotherapy, or radiotherapy, per protocol guidelines
Has protocol-defined adequate renal, hepatic and cardiac functions
If of reproductive potential, is permanently sterile or agrees to use highlyeffective birth control upon enrollment, during the period of therapy, and for 6months following the last dose of quizartinib, etoposide, fludarabine, methotrexate,or cytarabine, whichever is later
If female of child-bearing potential, tests negative for pregnancy and agrees not tobreast feed
Male participants must be surgically sterile or willing to use highly effectivebirth control during the treatment period, and for 6 months following the last doseof quizartinib, etoposide, fludarabine, methotrexate, or cytarabine, whichever islater.
Participant/legal representative is capable of understanding the investigationalnature of the study, potential risks, and benefits, and the patient (and/or legalrepresentative) signs a written assent/informed consent
Exclusion
Exclusion Criteria:
Participants who meet any of the following criteria will be disqualified from entering the study:
Has been diagnosed with isolated central nervous system relapse, acute promyelocyticleukemia (APL), juvenile myelomonocytic leukemia, French-American-Britishclassification M3 or WHO classification of APL with translocation, or with myeloidproliferations related to Down syndrome
Has uncontrolled or pre-defined significant cardiovascular disease as detailed inthe protocol
Has systemic fungal, bacterial, viral or other infection that is exhibiting ongoingsigns/symptoms related to the infection without improvement despite appropriateantibiotics or other treatment. The patient must be off vasopressors and havenegative blood cultures for at least 48 hours prior to the start of systematicprotocol therapy.
Has known active clinically relevant liver disease (e.g., active hepatitis B oractive hepatitis C)
Has known history of human immunodeficiency virus (HIV)
Has history of hypersensitivity to any of the study medications or their excipients
Is receiving or is anticipated to receive concomitant chemotherapy, radiation, orimmunotherapy other than as specified in the protocol
Has any significant concurrent disease, illness, psychiatric disorder or socialissue that would compromise subject safety or compliance, interfere withconsent/assent, study participation, follow up, or interpretation of study results
Is currently participating in another investigative interventional procedure (observational or long-term interventional follow-up is allowed)
Is otherwise considered inappropriate for the study by the Investigator
Study Design
Study Description
Connect with a study center
Universitair Ziekenhuis Gent
Gent,
BelgiumSite Not Available
The Hospital for Sick Children
Toronto, Ontario M5G1X8
CanadaSite Not Available
Montreal Children's Hospital
Montréal, Quebec H4A3J1
CanadaSite Not Available
British Columbia Children's Hospital
Vancouver, V6H 3V4
CanadaSite Not Available
Rigshospitalet
Copenhagen, 2100
DenmarkSite Not Available
Centre Léon Bérard
Lyon, 69008
FranceSite Not Available
Hôpital Armand-Trousseau
Paris, 75012
FranceSite Not Available
Hôpital des Enfants
Toulouse, 31300
FranceSite Not Available
Rambam Medical Center
Haifa, 31096
IsraelSite Not Available
Schneider Children's Medical Center of Israel
Petah Tikva, 49202
IsraelSite Not Available
Tel Aviv Sourasky Medical Center
Tel Aviv-Yafo, 64239
IsraelSite Not Available
Fondazione IRCCS San Gerardo dei Tintori
Monza, 20900
ItalySite Not Available
Fondazione MBBM - Clinica Pediatrica
Monza, 20900
ItalyActive - Recruiting
IRCCS Ospedale Pediatrico Bambino Gesù
Rome, 00165
ItalySite Not Available
Ospedale Infantile Regina Margherita
Torino, 10126
ItalySite Not Available
Prinses Maxima Centrum voor Kinderoncologie
Utrecht, 3584 EA
NetherlandsSite Not Available
Hospital Infantil Universitario Nino Jesus
Madrid, 28009
SpainSite Not Available
Hospital Universitario La Paz
Madrid, 28046
SpainSite Not Available
Sahlgrenska Universitetssjukhuset - Drottning Silvias Barn- och Ungdomssjukhus
Göteborg, 41685
SwedenSite Not Available
NHS Greater Glasgow and Clyde - The Queen Elizabeth University Hospital
Glasgow, G51 4TF
United KingdomSite Not Available
Loma Linda University Cancer Center
Loma Linda, California 92354
United StatesSite Not Available
University of California, San Francisco
San Francisco, California 94158
United StatesSite Not Available
Children's Hospital Colorado
Aurora, Colorado 80045
United StatesSite Not Available
A.I. duPont Hospital for Children
Wilmington, Delaware 19803
United StatesSite Not Available
Children's National Medical Center
Washington, District of Columbia 20010
United StatesSite Not Available
Children's Healthcare of Atlanta
Atlanta, Georgia 30322
United StatesSite Not Available
Riley Hospital for Children - Indiana University
Indianapolis, Indiana 46202
United StatesSite Not Available
Johns Hopkins
Baltimore, Maryland 21287
United StatesSite Not Available
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota 55455
United StatesSite Not Available
University of Mississippi Medical Center
Jackson, Mississippi 39216
United StatesSite Not Available
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
Columbia University/Herbert Irving Cancer Center
New York, New York 10032
United StatesSite Not Available
New York Medical College
Valhalla, New York 10595
United StatesSite Not Available
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United StatesSite Not Available
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania 15224
United StatesSite Not Available
The University of Texas Southwestern Medical Center Children's Health
Dallas, Texas 75390
United StatesSite Not Available
Seattle Children's Hospital
Seattle, Washington 98105
United StatesSite Not Available
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