Actively Recruiting
Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)
Led by PedAL BCU, LLC · Updated on 2026-04-28
130
Participants Needed
89
Research Sites
443 weeks
Total Duration
On this page
Sponsors
P
PedAL BCU, LLC
Lead Sponsor
P
Princess Maxima Center for Pediatric Oncology (European Sponsor)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have enrolled on APAL2020SC before this study if in USA, Canada, Australia, New Zealand, or Blood Cancer United territory.
- Participants must be at least 29 days old and no older than 21 years at enrollment.
- Participants must have AML without FLT3/internal tandem duplication mutation confirmed ideally at current relapse.
- Participants must have untreated second relapse AML and be fit for intensive chemotherapy, or untreated first relapse AML but unable to tolerate more anthracyclines.
- Participants must have an ECOG performance status of 0, 1, or 2 (or at least 50% Lansky or Karnofsky score).
- Participants must have recovered from prior anticancer treatments with required minimum time intervals before starting this study.
- Participants must have adequate kidney, liver, and heart function as specified.
- Participant or guardian must provide informed consent and assent when required.
You will not qualify if you...
- Participants unable to comply with study requirements.
- Participants with Down syndrome.
- Participants with acute promyelocytic leukemia or juvenile myelomonocytic leukemia.
- Participants with isolated or symptomatic CNS3 disease.
- Participants with malabsorption or conditions preventing oral venetoclax.
- Participants currently receiving other investigational drugs not specified.
- Participants with congenital bone marrow failure syndromes like Fanconi anemia.
- Participants with known allergy to study drugs.
- Participants with active uncontrolled infection.
- Participants with known hepatitis B, hepatitis C, or HIV infection.
- Participants who have recently taken strong or moderate CYP3A inducers or consumed grapefruit or similar products shortly before treatment.
- Participants who are pregnant or breastfeeding or unwilling to use effective contraception as required.
- Participants with history of severe veno-occlusive disease or CD33 negative leukemic blasts for gemtuzumab ozogamicin treatment exclusion.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 89 locations
1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
Actively Recruiting
2
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
Actively Recruiting
3
MemorialCare Miller Children's and Women's Hospital Long Beach
Long Beach, California, United States, 90806
Actively Recruiting
4
Children's Hospital of Orange County Main Campus - Orange
Orange, California, United States, 92868
Actively Recruiting
5
Benioff Children's Hospital - Mission Bay
San Francisco, California, United States, 94158
Actively Recruiting
6
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
7
Yale University
New Haven, Connecticut, United States, 06511
Actively Recruiting
8
Nemours Alfred I. Dupont Hospital for Children
Wilmington, Delaware, United States, 19803
Actively Recruiting
9
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, United States, 33908
Actively Recruiting
10
University of Florida Health Shands Children's Hospital
Gainesville, Florida, United States, 32610
Actively Recruiting
11
Nemours Children's Specialty Care Jacksonville
Jacksonville, Florida, United States, 32207
Actively Recruiting
12
Nemours Children's Hospital - Orlando
Orlando, Florida, United States, 32827
Actively Recruiting
13
Saint Joseph's Hospital - Tampa
Tampa, Florida, United States, 33607
Actively Recruiting
14
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Actively Recruiting
15
Kapi'olani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
Actively Recruiting
16
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
17
Comer Children's Hospital
Chicago, Illinois, United States, 60637
Actively Recruiting
18
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
Actively Recruiting
19
University of Iowa Stead Family Children's Hospital
Iowa City, Iowa, United States, 52242
Actively Recruiting
20
Norton Children's Hospital
Louisville, Kentucky, United States, 40202
Actively Recruiting
21
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
22
C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109-4259
Actively Recruiting
23
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
Actively Recruiting
24
Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
25
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Actively Recruiting
26
The Children's Mercy Hospital - Adele Hall Campus
Kansas City, Missouri, United States, 64108
Actively Recruiting
27
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
28
Alliance for Childhood Diseases dba Cure 4 The Kids Foundation
Las Vegas, Nevada, United States, 89135
Actively Recruiting
29
Hackensack University Medical Center, HMH
Hackensack, New Jersey, United States, 07601
Actively Recruiting
30
Morristown Medical Center
Morristown, New Jersey, United States, 07960
Actively Recruiting
31
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
32
Memorial Sloan Kettering Cancer Center - New York
New York, New York, United States, 10065
Actively Recruiting
33
Cohen Children's Medical Center
Queens, New York, United States, 11040
Actively Recruiting
34
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
35
Doernbecher Children's Hospital
Portland, Oregon, United States, 97239
Actively Recruiting
36
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
37
Prisma Health Richland Hospital
Columbia, South Carolina, United States, 29203
Actively Recruiting
38
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105-3678
Actively Recruiting
39
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States, 37232
Actively Recruiting
40
Harold C. Simmons Comprehensive Cancer Center
Dallas, Texas, United States, 75235
Actively Recruiting
41
Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
42
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113
Actively Recruiting
43
Children's Hospital of Richmond at Virginia Commonwealth University
Richmond, Virginia, United States, 23219
Actively Recruiting
44
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
45
Children's Health Queensland Hospital and Health Service
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
46
The Royal Children's Hospital - Children's Cancer Centre
Parkville, Victoria, Australia, 3052
Actively Recruiting
47
Perth Children's Hospital
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
48
Sankt Anna-Kinderspital
Vienna, Austria, 1090
Actively Recruiting
49
Universitair Ziekenhuis Gent
Ghent, Oost-Vlaanderen, Belgium, 9000
Actively Recruiting
50
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
Actively Recruiting
51
British Columbia Children's Hospital
Vancouver, British Columbia, Canada, V6H 3N1
Completed
52
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Actively Recruiting
53
Izaak Walton Killam (IWK) Health Center
Halifax, Nova Scotia, Canada, B3K 6R8
Actively Recruiting
54
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Actively Recruiting
55
SickKids - The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Actively Recruiting
56
Fakultni nemocnice v Motole
Prague, Prague, Czechia, 150 06
Actively Recruiting
57
Rigshospitalet
Copenhagen, Capital Region, Denmark, 2100
Actively Recruiting
58
Uusi Lastensairaala
Helsinki, Etelä-Suomen Lääni, Finland, FI-00290
Actively Recruiting
59
CHU de Toulouse - Hôpital des Enfants
Toulouse, Haute-Garonne, France, 31059
Actively Recruiting
60
Hôpital Jeanne de Flandre
Loos, Hauts-de-France, France, 59120
Actively Recruiting
61
CHU de Nantes - Hôpital Femme-Enfant-Adolescent
Nantes, Loire-Atlantique, France, 44093
Actively Recruiting
62
Institut d'Hématologie et d'Oncologie Pédiatrique
Lyon, Rhône, France, 69008
Actively Recruiting
63
Hôpital Armand-Trousseau
Paris, Île-de-France Region, France, 75012
Actively Recruiting
64
Hôpital Universitaire Robert-Debré
Paris, Île-de-France Region, France, 75019
Actively Recruiting
65
Universitätsklinikum Augsburg
Augsburg, Germany, 86156
Actively Recruiting
66
Charité - Universitätsmedizin Berlin
Berlin, Germany, 13353
Actively Recruiting
67
Universitätsklinikum Frankfurt
Frankfurt, Germany, 60590
Actively Recruiting
68
Padiatrische Hamatologie und Onkologie
Münster, Germany, 48149
Actively Recruiting
69
Universitätsklinikum Münster
Münster, Germany, 49149
Actively Recruiting
70
Schneider Children's Medical Center of Israel
Petach Tikvah, Central District, Israel, 4920235
Actively Recruiting
71
Istituto Giannina Gaslini
Genova, Genoa, Italy, 16147
Actively Recruiting
72
Fondazione IRCCS San Gerardo dei Tintori
Monza, Monza and Brianza, Italy, 20900
Actively Recruiting
73
Ospedale Pediatrico Bambino Gesù
Roma, Rome, Italy, 00165
Actively Recruiting
74
Ospedale Infantile Regina Margherita
Torino, Turin, Italy, 10126
Actively Recruiting
75
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
Nagoya, Aiti, Japan, 453-8511
Actively Recruiting
76
Hyogo Prefectural Kobe Children's Hospital
Kobe, Hyōgo, Japan, 650-0047
Actively Recruiting
77
Saitama Prefectural Children's Medical Center
Saitama-Shi, Saitama, Japan, 330-8777
Actively Recruiting
78
National Center for Child Health and Development
Setagaya-Ku, Tokyo, Japan, 157-8535
Actively Recruiting
79
Osaka City General Hospital
Osaka, Japan, 534-0021
Actively Recruiting
80
Prinses Maxima Centrum Kinderoncologie
Utrecht, Netherlands, 3584 CS
Actively Recruiting
81
Starship Children's Hospital
Grafton, Auckland, New Zealand, 1023
Actively Recruiting
82
Oslo Universitetssykehus
Oslo, Norway, 0372
Actively Recruiting
83
Instituto Portugues De Oncologia De Lisboa Francisco Gentil
Lisbon, Lisbon District, Portugal, 1099-023
Actively Recruiting
84
Hospital Universitari Vall d'Hebrón
Barcelona, Spain, 08035
Actively Recruiting
85
Hospital Sant Joan de Déu Barcelona
Barcelona, Spain, 08950
Actively Recruiting
86
Hospital Infantil Universitario Niño Jesús
Madrid, Spain, 28009
Actively Recruiting
87
Hospital Universitario La Fe
Valencia, Spain, 46026
Actively Recruiting
88
Karolinska Universitetssjukhuset Solna
Stockholm, Stockholm County, Sweden, 171 76
Actively Recruiting
89
Universitaets - Kinderspital Zürich
Zurich, Switzerland, 8032
Actively Recruiting
Research Team
G
Gwen Nichols, MD
CONTACT
M
Michel Zwaan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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