Go to family friendly version
| Diagnosis | Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Acute Myeloid Leukemia Post Cytotoxic Therapy, Juvenile Myelomonocytic Leukemia, Mixed Phenotype Acute Leukemia, Myelodysplastic Syndrome Post Cytotoxic Therapy | Study Status | Open |
| Phase | I/II |
| Age | Less than 22 years of age | Randomisation | NO |
| Line of treatment | Disease relapse or progression |
| Routes of Treatment Administration | Procedure: Biospecimen Collection
Undergo collection of blood and/or bone marrow samples |
| Last Posted Update | 2024-02-12 |
| ClinicalTrials.gov # | NCT04726241 |
International Sponsor
LLS PedAL Initiative, LLCPrincipal Investigators for Canadian Sites
CHU Quebec - Dr. Bruno Michon
Alberta Children's Hospital - Dr. Victor Lewis
Stollery Children's Hospital - Dr Sarah McKillop
BC Children's Hospital - Dr. Rebecca Deyell
CancerCare Manitoba - Dr. Ashley Chopek
IWK Health Centre - Dr. Craig Erker
London Children's Hospital - Dr. Shayna Zelcer
Children's Hospital Eastern Ontario (CHEO) - Dr. Donna Johnson
The Hospital for Sick Children - Dr. Johann Hitzler
Montreal Children's Hospital - Dr. Stephanie Mourad
CHU Ste. Justine - Dr. Monia MarzoukiCentres
Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
Social worker/patient navigator contact
Marie-Claude Charrette
Clinical research contact
Marie Saint-Jacques
Medical contact
Raoul Santiago
Social worker/patient navigator contact
Isabelle Audet
Clinical research contact
Barbara Desbiens
Medical contact
Clinical Research Unit
Social worker/patient navigator contact
Clinical Research Unit
Clinical research contact
Stephanie Badour
Medical contact
Dr. Donna Johnston
Dr. Lesleigh Abbott
Dr. Doaa Abdel Fattah
Social worker/patient navigator contact
Sherley Telisma
Clinical research contact
Carol Duchenne
Medical contact
Dr. Alexandra Zorzi
Dr. Shayna Zelcer
Social worker/patient navigator contact
Cindy Milne Wren
Jessica Mackenzie Harris
Clinical research contact
Mariam Mikhail
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. Magimairajan Vanan
Social worker/patient navigator contact
Rhéanne Bisson
Clinical research contact
Rebekah Hiebert
Megan Ridler
Kathy Hjalmarsson
Medical contact
Rebecca Deyell
Social worker/patient navigator contact
Ilana Katz
Clinical research contact
Hem/Onc/BMT Clinical Trials Unit
Medical contact
Dr. Victor Lewis
Social worker/patient navigator contact
Wendy Pelletier
Clinical research contact
Debra Rich
Medical contact
Dr. Sarah McKillop
Dr. Sunil Desai
Social worker/patient navigator contact
Danielle Sikora
Michelle Woytiuk
Jaime Hobbs
Clinical research contact
Amanda Perreault
Study Description
This study aims to use clinical and biological characteristics of acute leukemias to screen for patient eligibility for available pediatric leukemia sub-trials. Testing bone marrow and blood from patients with leukemia that has come back after treatment or is difficult to treat may provide information about the patient's leukemia that is important when deciding how to best treat it and may help doctors find better ways to diagnose and treat leukemia in children, adolescents, and young adults.
PRIMARY OBJECTIVES:
I. To utilize clinical and biological characteristics of acute leukemias to screen for patient eligibility for available phase I/II Pediatric Acute Leukemia (PedAL) sub-trials.
II. To maintain a longitudinal and comprehensive registry from relapse in children and young adults with recurrent and refractory leukemia.
OUTLINE:
Patients undergo collection of blood and/or bone marrow samples at baseline, end of treatment cycle(s), and at relapse/refractory disease status (if applicable).
After completion of study, patients are followed up every 3 months for 2 years, and then every 6 months for 3 years.
Inclusion Criteria
- Patients must be less than 22 years of age at the time of study enrollment
- Patient must have one of the following:
- Patient has known or suspected relapsed/refractory (including primary refractory) AML
- This includes isolated myeloid sarcoma
- Patient has known or suspected relapsed/refractory (including primary refractory) myeloid leukemia of Down syndrome
- Patient has known or suspected relapsed ALL that meets one of the following criteria:
- Second or greater B-ALL medullary relapse, excluding KMT2Ar.
- Any first or greater B-ALL medullary relapse involving KMT2Ar.
- Any first or greater T-ALL medullary relapse with or without KMT2Ar.
- Patient has known or suspected relapsed/refractory (including primary refractory) mixed phenotype acute leukemia (MPAL)
- Patient has known or suspected de novo or relapsed/refractory (including primary refractory) treatment-related AML (t-AML) or treatment-related myelodysplastic syndrome (t-MDS)
- Patient has known or suspected de novo or relapsed/refractory (including primary refractory) myelodysplastic syndrome (MDS)
- Patient has known or suspected de novo or relapsed/refractory (including primary refractory) juvenile myelomonocytic leukemia (JMML)
- All patients and/or their parents or legal guardians must sign a written informed consent
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria
Not outlined on clinicaltrials.gov
