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Information is also accessible through the patient and families tab. Family friendly summaries are created and reviewed by our advocacy partners. The information is updated to the best of our knowledge but might not reflect the latest information. Note that most studies are only available at a limited number of sites, please click on ‘further information’ for details. Studies, particularly early phase trials, may also temporarily close to enrolment or not have slots available for all treatment groups. In all cases, study teams at individual C17 centres will have the most up-to-date information.

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Title
Status

 

ACT15378 ISAKIDS - Open-label, Single-arm Trial to Evaluate Antitumor Activity, Safety, and Pharmacokinetics of Isatuximab Used in Combination With Chemotherapy in Pediatric Patients From 28 Days to Less Than 18 Years of Age With Relapsed/Refractory B or T Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia in First or Second Relapse

Suspended

More information

ACT15378 ISAKIDS - Open-label, Single-arm Trial to Evaluate Antitumor Activity, Safety, and Pharmacokinetics of Isatuximab Used in Combination With Chemotherapy in Pediatric Patients From 28 Days to Less Than 18 Years of Age With Relapsed/Refractory B or T Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia in First or Second Relapse

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DiagnosisAcute Lymphoblastic Leukemia, Acute Myeloid LeukemiaStudy StatusSuspended
PhaseII
AgeChild - (up to 17 Years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationIntravenous for isatuximab; Other drugs as usually administered for leukemia therapy
Last Posted Update2024-01-08
ClinicalTrials.gov #NCT03860844
International Sponsor
Sanofi
Principal Investigators for Canadian Sites
Montreal Children’s Hospital - Dr. Surabhi Rawal
BC Children's Hospital - Dr. Amanda Li
Centres
Medical contact
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 
Medical contact
Rebecca Deyell

 

Social worker/patient navigator contact
Ilana Katz 

 

Clinical research contact
Hem/Onc/BMT Clinical Trials Unit

 

 

 

Study Description

This is study of a new medication called isatuximab (antibody against a marker called CD38) in combination with standard chemotherapy for children with acute lymphoblastic leukemia or acute myeloid leukemia that has relapsed or is refractory to treatment. The main objective of this study is to understand the anti-leukemia effect of this medication. 

Inclusion Criteria
  • Age between 28 days to less than 18 years of age
  • Acute lymphoblastic leukemia or acute myeloid leukemia that has relapsed or is refractory to treatment
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team