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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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EndRAD (ONC1701) - A Phase II Pilot Trial to Estimate Survival After a Non-total Body Irradiation (TBI) Based Conditioning Regimen in Patients Diagnosed With B-acute Lymphoblastic Leukemia (ALL) Who Are Pre-allogeneic Hematopoietic Cell Transplantation (HCT) Next-generation-sequence (NGS) Minimal Residual Disease (MRD) Negative

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EndRAD (ONC1701) - A Phase II Pilot Trial to Estimate Survival After a Non-total Body Irradiation (TBI) Based Conditioning Regimen in Patients Diagnosed With B-acute Lymphoblastic Leukemia (ALL) Who Are Pre-allogeneic Hematopoietic Cell Transplantation (HCT) Next-generation-sequence (NGS) Minimal Residual Disease (MRD) Negative

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DiagnosisB-cell Acute Lymphoblastic LeukemiaStudy StatusOpen
PhaseII
Age1 Year to 25 YearsRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: Myeloablative allogeneic HCT with a non-TBI conditioning regimen. Myeloablative study regimen will consist of busulfan, fludarabine and thiotepa.
Last Posted Update2025-07-16
ClinicalTrials.gov #NCT03509961
International Sponsor
Pediatric Transplantation & Cellular Therapy Consortium
Principal Investigators for Canadian Sites
Alberta Children's Hospital - Dr. Tony Truong
Centres
Medical contact
Dr. Victor Lewis

 

Social worker/patient navigator contact
Wendy Pelletier
Clinical research contact
Debra Rich

 

 

Study Description

This study is for children and young people with B-cell acute lymphoblastic leukemia (B-ALL) who need a bone marrow transplant.

Before the transplant, doctors will check the bone marrow using a very sensitive test to see if there are any tiny signs of leukemia left.

  • If no leukemia is found, the patient may get a gentler treatment before the transplant (called non-TBI conditioning).

  • If some leukemia is still found, the patient will get the usual treatment their hospital gives. These patients will still be part of the study so doctors can learn from their care.

The goal is to see if the gentler treatment is safe for patients with a lower chance of the leukemia coming back.

Inclusion Criteria

For Treatment Arm: 

  • Must be between 1 and 25 years old
  • Has B-ALL and is in first or second remission
  • Test shows no leukemia before transplant (NGS-MRD negative)
  • Has not had a stem cell transplant before
  • Must be up and about at least 60% of participants waking hours and well enough for transplant
  • Can give consent (or has a guardian who can)
  • Meets all organ function requirements 

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team.