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| Diagnosis | Acute Myeloid Leukemia | Study Status | Open |
| Phase | III |
| Age | 29 Days to 21 Years | Randomisation | YES |
| Line of treatment | Disease relapse or progression |
| Routes of Treatment Administration | Drug: Fludarabine - Intravenous (IV) infusion
Drug: Cytarabine - Intravenous (IV) infusion
Drug: Gemtuzumab Ozogamicin - Intravenous (IV) infusion
Drug: Azacitidine - Intravenous (IV) infusion or subcutaneous injection
Experimental Arm
Drug: Venetoclax - Orally via tablet or powder suspension |
| Last Posted Update | 2024-05-10 |
| ClinicalTrials.gov # | NCT05183035 |
International Sponsor
LLS PedAL Initiative, LLCPrincipal Investigators for Canadian Sites
BC Children's Hospital
CancerCare Manitoba
IWK Health Center
Children's Hospital of Eastern Ontario (CHEO)
SickKids - The Hospital for Sick Children - Dr. Jim WhitlockCentres
Medical contact
Rebecca Deyell
Social worker/patient navigator contact
Ilana Katz
Clinical research contact
Hem/Onc/BMT Clinical Trials Unit
Medical contact
Dr. Magimairajan Vanan
Social worker/patient navigator contact
Rhéanne Bisson
Clinical research contact
Rebekah Hiebert
Megan Ridler
Kathy Hjalmarsson
Medical contact
Dr. Craig Erker
Dr. Conrad Fernandez
Dr. Ketan Kulkarni
Social worker/patient navigator contact
Rhonda Brophy
Clinical research contact
Tina Bocking
Medical contact
Dr. Donna Johnston
Dr. Lesleigh Abbott
Dr. Doaa Abdel Fattah
Social worker/patient navigator contact
Sherley Telisma
Clinical research contact
Carol Duchenne
Study Description
This study evaluates if the addition of a drug called venetoclax to chemotherapy improves survival of relapsed acute myeloid leukemia (AML). This is a trial for children, adolescents and young adults with 2nd relapsed AML or 1st relapsed AML unable to receive additional anthracycline containing chemotherapy.
Inclusion Criteria
- Participants must be ≥ 29 days of age and ≤ 21 years of age at enrollment.
- Participants must have previously been enrolled on APAL2020SC prior to starting this study
- Participants or their parents/guardians must sign a consent form to be on this study
- Participants must be children, adolescents, and young adults with relapsed acute myeloid leukemia (AML) with either 2nd relapsed AML or 1st relapsed AML unable to receive additional anthracycline containing chemotherapy.
- AML must not have a mutation called FLT3/internal tandem duplication (ITD)
- Participants must have fully recovered from all prior anti-cancer therapy and must meet the minimum durations from prior anti-cancer directed therapy prior to start of protocol treatment. These timelines will be discussed with you by the study team.
- Participants must have an adequate performance status (daily activity level)
- Adequate organ function of the kidneys, liver and heart
Other inclusion and exclusion criteria may apply and will be discussed with you by the study team
