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Diagnosis | ALL, Acute Lymphoblastic Leukemia | Study Status | Closed to enrollment |
Phase | II |
Age | Child - up to 364 days | Randomisation | N/A |
Line of treatment | First line treatment |
Routes of Treatment Administration | Azacitidine IV
Other drugs are given as usually administered for ALL therapy |
Last Posted Update | 2022-04-25 |
ClinicalTrials.gov # | NCT02828358 |
International Sponsor
National Cancer Institute (NCI)Principal Investigators for Canadian Sites
CancerCare Manitoba – Dr. Ashley Chopek
Children's Hospital of Western Ontario – Dr. Shayna Miriam Zelcer
The Hospital for Sick Children – Dr. Ute Bartels
IWK Health Centre – Dr. Craig Erker
Cancer Centre of Southeastern Ontario at Kingston General Hospital – Dr. Mariana Silva
Montreal Children's Hospital - Dr. Sharon Abish
Children’s Hospital of Eastern Ontario (CHEO) – Dr. Donna Johnston
Janeway Hospital – Dr. Lisa Goodyear
Centres
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. Laura Wheaton
Dr. Mariana Silva
Social worker/patient navigator contact
Jessica Amey
Clinical research contact
Heather McLean
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
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. Paul Moorehead
Social worker/patient navigator contact
Stephanie Eason
Clinical research contact
Bev Mitchell
Study Description
This study is to assess the effectiveness of a chemotherapy called azacitidine in addition to the standard chemotherapy in infants diagnosed with acute lymphoblastic leukemia with a certain mutation called KMT2A-rearrangement.
Enrolled patients will receive four courses of azacitidine during their treatment. The study also looks at the side effects associated with these medications.
Inclusion Criteria
- Children less than 1 year of age
- New diagnosis of acute lymphoblastic leukemia
- Presence of a change called "KMT2A-rearrangement" in the leukemia cells
Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.