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1 results found

Title
Status

 

AALL15P1 - A Groupwide Pilot Study to Test the Tolerability and Biologic Activity of the Addition of Azacitidine (NSC# 102816) to Chemotherapy in Infants With Acute Lymphoblastic Leukemia (ALL) and KMT2A (MLL) Gene Rearrangement

Closed to enrollment

AALL15P1 - A Groupwide Pilot Study to Test the Tolerability and Biologic Activity of the Addition of Azacitidine (NSC# 102816) to Chemotherapy in Infants With Acute Lymphoblastic Leukemia (ALL) and KMT2A (MLL) Gene Rearrangement

Go to Health Care Provider version

DiagnosisALL, Acute Lymphoblastic Leukemia Study StatusClosed to enrollment
PhaseII
AgeChild - up to 364 daysRandomisationN/A
Line of treatmentFirst line treatment
Routes of Treatment AdministrationAzacitidine IV Other drugs are given as usually administered for ALL therapy
Last Posted Update2022-04-25
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

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

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.