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| Diagnosis | KMT2A-Rearranged Infant Leukemia | Study Status | Open |
| Phase | II |
| Age | 1 Month to 6 Years | Randomisation | NO |
| Line of treatment | Disease relapse or progression |
| Routes of Treatment Administration | Drug: Revumenib (SNDX-5613) - Oral (or NG/NJ/ND/G-tube)
Combination Chemotherapy Regimens:
(1) vincristine (IV), prednisone or prednisolone (PO or via NG, ND, NJ, or G-tube), calaspargase pegol-mknl (IV), methotrexate (MTX) (IT), hydrocortisone (IT), cytarabine (IT)
(2) fludarabine (IV), high-dose cytarabine (IV)
(3) fludarabine (IV), high-dose cytarabine (IV), MTX (IT), hydrocortisone (IT), and cytarabine (IT)
(4) monotherapy. Patients may also receive MTX (IT), hydrocortisone (IT), and cytarabine (IT) as clinically indicated. |
| Last Posted Update | 2025-07-16 |
| ClinicalTrials.gov # | NCT05761171 |
International Sponsor
Children's Oncology GroupPrincipal Investigators for Canadian Sites
CHU Ste Justine - Dr. Thai Tran
BC Children's Hospital - Dr. Rebecca Deyell
CancerCare Manitoba - Dr. Stephanie Villeneuve
IWK Health Centre - Dr. Craig Erker
McMaster Children's Hospital - Dr. Uma Athale
London Children's Hospital - Dr. Shayna Zelcer
CHEO - Dr. Donna Johnston
The Hospital for Sick Children - Dr. Jim WhitlockCentres
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
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. Carol Portwine
Social worker/patient navigator contact
Jane Cassano
Clinical research contact
Sabrina Millson
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. Donna Johnston
Dr. Lesleigh Abbott
Dr. Nirav Thacker
Social worker/patient navigator contact
Sherley Telisma
Clinical research contact
Isabelle Laforest
Study Description
This study is for babies and young children with leukemia that has come back or isn’t getting better with treatment. Some kids with leukemia have a gene change called KMT2A rearrangement, which makes the cancer harder to treat and more likely to come back. Doctors are testing a new medicine called revumenib. It is a pill that helps target and kill leukemia cells with this gene change.
In this study, children will get revumenib along with regular chemotherapy.
Inclusion Criteria
- Between 1 month to 6 years old
- First diagnosed with leukemia before age 2
- Has a certain type of leukemia with a KMT2A gene change that has come back or didn’t respond to treatment
- Types of leukemia allowed:
- Acute lymphoblastic leukemia (ALL)
- Mixed or unclear type (MPAL or ALAL)
- Up and about at least 50% of waking hours
- Can take medicine by mouth or feeding tube
- Has recovered from any side effects of past treatment
- Meets all organ function and blood work requirements
Other inclusion and exclusion criteria may apply and will be discussed with you by the study team.
