Canadian clinical trial registry

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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.

112 results found

Title
Status

 

AALL2121 - A Phase 2 Study of Revumenib (SNDX-5613) in Combination With Chemotherapy for Patients With Relapsed or Refractory KMT2A-Rearranged Infant Leukemia

Open

AALL2121 - A Phase 2 Study of Revumenib (SNDX-5613) in Combination With Chemotherapy for Patients With Relapsed or Refractory KMT2A-Rearranged Infant Leukemia

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DiagnosisKMT2A-Rearranged Infant LeukemiaStudy StatusOpen
PhaseII
Age1 Month to 6 Years RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: 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 Update2025-07-16
ClinicalTrials.gov #NCT05761171
International Sponsor
Children's Oncology Group
Principal 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 Whitlock
Centres
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
Doaa Abdelfattah
 
Isabelle Laforest
 
 
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

 

 

 

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. 

CFZ008 - Phase 1b Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia

Closed

CFZ008 - Phase 1b Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia

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DiagnosisAcute Lymphoblastic LeukemiaStudy StatusClosed
PhaseI
AgeChild, Adult - (1 Year to 21 Years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment Administrationintravenous (carfilzomib); Other drugs as usually administered for leukemia therapy
Last Posted Update2025-07-16
ClinicalTrials.gov #NCT02303821
International Sponsor
Amgen
Principal Investigators for Canadian Sites
CHU Ste-Justine - Dr. Henrique Bittencourt

Centres
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
 

 

 

Study Description

This phase I/II trial is trying to determine how much carfilzomib (an anti-cancer drug) should be used, alone and in combination with induction chemotherapy, to treat children with acute lymphoblastic leukemia that has come back (relapsed) or is refractory to treatment. Carfilzomib is an anti-cancer medication called proteasome inhibitor and is given intravenously.

 

Inclusion Criteria
  • Age 1 year to 21 years
  • Acute lymphoblastic leukaemia that has come back (relapsed) or is refractory to treatment
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

M20-429 - A Single Arm, Open-Label, Phase 1b Trial of Epcoritamab in Pediatric Patients With Relapsed/Refractory Aggressive Mature B-cell Neoplasms

Closed

M20-429 - A Single Arm, Open-Label, Phase 1b Trial of Epcoritamab in Pediatric Patients With Relapsed/Refractory Aggressive Mature B-cell Neoplasms

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DiagnosisNon-hodgkin LymphomaStudy StatusClosed
PhaseI
Age1 to 25 Years OldRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: Epcoritamab Subcutaneous Injection (SC) Other Name: ABBV-GMAB-3013
Last Posted Update2025-07-16
ClinicalTrials.gov #NCT05206357
International Sponsor
AbbVie
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Sarah Alexander
CHU Sainte-Justine - Dr. Henrique Bittencourt
Centres
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
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
 

 

 

Study Description

The purpose of this study is to assess the safety and tolerability of the study drug epcoritamab in pediatric participants with relapsed/refractory aggressive mature B-cell neoplasms. The study drug will be given subcutaneously in 28 day cycles and participants will be followed for a minimum of 3 years after enrolling.

Inclusion Criteria
  • Participants must have Burkitt's or Burkitt-like lymphoma/leukemia, diffuse large B-cell lymphoma, or other aggressive mature B-cell lymphomas 
  • Tumour must have come back (relapsed) or progressed after previous treatment
  • Between 1-18 years of age
  • Participants must be able to be up and about at least half of their waking hours
  • Adequate organ function 

Other inclusion or exclusion criteria may apply and will be discussed with you by the clinical team

ReRAD - A Phase II Canadian Pediatric Brain Tumour Consortium Study of Re-Irradiation as Treatment of Progressive or Recurrent Diffuse Intrinsic Pontine Glioma

Closed

ReRAD - A Phase II Canadian Pediatric Brain Tumour Consortium Study of Re-Irradiation as Treatment of Progressive or Recurrent Diffuse Intrinsic Pontine Glioma

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DiagnosisRecurrent or Progressive Diffuse Intrinsic Pontine GliomaStudy StatusClosed
PhaseII
AgeChild - (up to 17 Years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationPatients will receive 30.6 Gy or 36 Gy of a second course of radiation therapy for progressive or recurrent DIPG
Last Posted Update2025-07-16
ClinicalTrials.gov #NCT03126266
International Sponsor
University of Calgary
Principal Investigators for Canadian Sites
Alberta Children’s Hospital - Dr. Lucie Lafay-Cousin
Stollery Children’s Hospital - Dr. Bev Wilson
Children's Hospital of Eastern Ontario (CHEO) - Dr. Donna Johnston
Hamilton Health Sciences Centre, Mc Master University
BC Children’s Hospital – Dr. Juliette Hukin
Montreal Children's Hospital – Dr. Freeman
CHU Ste-Justine – Dr. Yvan Samson
CHU de Quebec – Dr. Samuele Renzi
Children's Hospital of Western Ontario – Dr. Shayna Zelcer
Janeway Hospital - Dr. Lynette Bowes
The Hospital for Sick Children - Dr. Ute Bartels
Centres
Medical contact
Dr. Victor Lewis

 

Social worker/patient navigator contact
Wendy Pelletier
Clinical research contact
Debra Rich
Medical contact
Dr. Sarah McKillop
Dr. Sunil Desai

 

 

Social worker/patient navigator contact
Danielle Sikora
 Michelle Woytiuk 
Jaime Hobbs
Clinical research contact
Amanda Perreault
Medical contact
Dr. Donna Johnston
 
Dr. Lesleigh Abbott
 
Dr. Nirav Thacker
 
Social worker/patient navigator contact
Sherley Telisma
 
Clinical research contact
Doaa Abdelfattah
 
Isabelle Laforest
 
 
Medical contact
Dr. Carol Portwine
 
Social worker/patient navigator contact
Jane Cassano 
 
Clinical research contact
Sabrina Millson
 
 
Medical contact
Rebecca Deyell

 

Social worker/patient navigator contact
Ilana Katz 

 

Clinical research contact
Hem/Onc/BMT Clinical Trials Unit

 

Medical contact
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 
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
Raoul Santiago
 
Social worker/patient navigator contact
Isabelle Audet
 
Clinical research contact
Barbara Desbiens
 

 

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. Paul Moorehead
 
Social worker/patient navigator contact
Stephanie Eason
 
Clinical research contact
Bev Mitchell
 
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

 

 

 

Study Description

Diffuse Intrinsic Pontine Glioma (DIPG) is an aggressive brain tumour with no effective treatment and no chance of long-term survival . When this brain tumour grows back after the initial radiation therapy, it is known as progressive or recurrent DIPG.

This study will investigate how long a second treatment with radiation (re-irradiation) keeps progressive or recurrent DIPG from growing again and the overall survival of these patients. All children enrolled will be treated with re-irradiation.

Inclusion Criteria
  • The patient is 17 years of age or younger at the time of first or second relapse or progression of disease
  • The patient has no evidence of metastases on MRI of the brain and the spine
  • The patient has received radiation in the past, given to a total dose of <60 Gy
  • At least 180 days (6 months) have elapsed from the last day of primary radiation
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

APAL2020D - A Randomized Phase 3 Trial of Fludarabine/Cytarabine/Gemtuzumab Ozogamicin With or Without Venetoclax in Children With Relapsed AML

Open

APAL2020D - A Randomized Phase 3 Trial of Fludarabine/Cytarabine/Gemtuzumab Ozogamicin With or Without Venetoclax in Children With Relapsed AML

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DiagnosisAcute Myeloid LeukemiaStudy StatusOpen
PhaseIII
Age29 Days to 21 YearsRandomisationYES
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: Fludarabine - Intravenous (IV) infusion Drug: Cytarabine - Intravenous (IV) infusion Drug: Gemtuzumab Ozogamicin - Intravenous (IV) infusion Drug: Azacitidine - Intravenous (IV) infusion or subcutaneous injection Experimental Arm Drug: Venetoclax - Orally via tablet or powder suspension
Last Posted Update2025-07-16
ClinicalTrials.gov #NCT05183035
International Sponsor
LLS PedAL Initiative, LLC
Principal Investigators for Canadian Sites
BC Children's Hospital - Dr. Rebecca Deyell
CancerCare Manitoba
IWK Health Center
Children's Hospital of Eastern Ontario (CHEO)
SickKids - The Hospital for Sick Children - Dr. Jim Whitlock
Centres
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
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. Donna Johnston
 
Dr. Lesleigh Abbott
 
Dr. Nirav Thacker
 
Social worker/patient navigator contact
Sherley Telisma
 
Clinical research contact
Doaa Abdelfattah
 
Isabelle Laforest
 
 

 

 

Study Description

This study evaluates if the addition of a drug called venetoclax to chemotherapy improves survival of relapsed acute myeloid leukemia (AML). This is a trial for children, adolescents and young adults with 2nd relapsed AML or 1st relapsed AML unable to receive additional anthracycline containing chemotherapy.

Inclusion Criteria
  • Participants must be ≥ 29 days of age and ≤ 21 years of age at enrollment.
  • Participants must have previously been enrolled on APAL2020SC prior to starting this study 
  • Participants or their parents/guardians must sign a consent form to be on this study
  • Participants must be children, adolescents, and young adults with relapsed acute myeloid leukemia (AML) with either 2nd relapsed AML or 1st relapsed AML unable to receive additional anthracycline containing chemotherapy. 
  • AML must not have a mutation called FLT3/internal tandem duplication (ITD)
  • Participants must have fully recovered from all prior anti-cancer therapy and must meet the minimum durations from prior anti-cancer directed therapy prior to start of protocol treatment. These timelines will be discussed with you by the study team. 
  • Participants must have an adequate performance status (daily activity level)
  • Adequate organ function of the kidneys, liver and heart

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






     
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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

Open

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.

CONNECT1905 - Phase 2 Study of Systemic IL-6 Receptor Antagonist ACTEMRA® (Tocilizumab) for the Treatment of Progressive/Recurrent Pediatric Adamantinomatous Craniopharyngioma

Open

CONNECT1905 - Phase 2 Study of Systemic IL-6 Receptor Antagonist ACTEMRA® (Tocilizumab) for the Treatment of Progressive/Recurrent Pediatric Adamantinomatous Craniopharyngioma

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DiagnosisAdamantinomatous Craniopharyngioma, Recurrent Adamantinomatous CraniopharyngiomaStudy StatusOpen
PhaseII
Age1 Year to 25 YearsRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: Tocilizumab (Route: IV)
Last Posted Update2025-06-18
ClinicalTrials.gov #NCT05233397
International Sponsor
Sponsor:
Nationwide Children's Hospital

Collaborator:
Children's Hospital Colorado
Principal Investigators for Canadian Sites
The Hospital for Sick Children (SickKids): Dr. Julie Bennett
Montreal Children's Hospital: Dr. Geneviève Legault
Stollery Children's Hospital: Dr. Liana Nobre
Centres
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. Sarah McKillop
Dr. Sunil Desai

 

 

Social worker/patient navigator contact
Danielle Sikora
 Michelle Woytiuk 
Jaime Hobbs
Clinical research contact
Amanda Perreault

 

 

Study Description

In this study, a drug called tocilizumab will be used to treat patients with a brain tumour called Adamantinomatous Craniopharyngioma between the ages of 1 and 25 years old. This cancer is currently treated with surgery and radiation, which can impact the quality of life for patients - instead, this drug interacts with IL-6, which is a type of protein in your body called a cytokine. By blocking the function of IL-6, this study explores if the drug is safe and effective at inducing a tumor response.

Inclusion Criteria
  • Participants must be ≥ 12 months and ≤ 25 years of age at the time of study enrollment.
  • Participants must have a confirmed diagnosis of adamantinomatous craniopharyngioma that has previously been treated
  • Participants must be up and about at least half of their waking hours
  • Must have recovered from the effects of any prior therapies
  • Participants must meet the organ function and lab work requirements 
  • Participants and/or their parents or legal authorized representatives must sign a written informed consent.

 

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

APAL2020K - A Phase 1 Trial of Menin-inhibitor Ziftomenib in Combination With Chemotherapy for Children With Relapsed/Refractory KMT2A-r/NUP98-r/NPM1-m Acute Leukemia

Open

APAL2020K - A Phase 1 Trial of Menin-inhibitor Ziftomenib in Combination With Chemotherapy for Children With Relapsed/Refractory KMT2A-r/NUP98-r/NPM1-m Acute Leukemia

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DiagnosisAcute LeukemiaStudy StatusOpen
PhaseI
Age0 Years to 21 Years RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: Ziftomenib (Oral capsule) Drug: Cytarabine (Intravenous (IV)) Drug: Fludarabine (Intravenous (IV))
Last Posted Update2025-05-14
ClinicalTrials.gov #NCT06376162
International Sponsor
LLS PedAL Initiative, LLC
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Jim Whitlock
Centres
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

 

 

 

Study Description

The objective of this study is to determine the safety and efficacy of a drug called ziftomenib in combination with chemotherapy in children with acute leukemia that has progressed or come back with specific genetic mutations. 

Inclusion Criteria
  • Participants up to 21 years old that weigh at least 5kg
  • Has leukemia that came back or didn’t respond to treatment and has a has a specific gene change
  • Participants must be up and about at least 50% of waking hours, wheelchair use is included
  • Must meet all blood work and organ function requirements 
  • Must have had enough time to recover from any past treatments
  • Must first enroll in APAL2020SC prior to enrollment in this trial 
  • Participant or Parent/Guardian must sign informed consent form

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