Canadian clinical trial registry

Search results

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.

108 results found

Title
Status

 

AREN1921 - Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)

Open

AREN1921 - Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)

Go to Health Care Provider version

DiagnosisAnaplastic Wilms Tumor, Recurrent Wilms TumorStudy StatusOpen
PhaseII
Ageup to 30 YearsRandomisationNO
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment AdministrationChemotherapy medications, all given intravenously (Carboplatin, Cyclophosphamide, Doxorubicin, Etoposide, Ifosfamide, Irinotecan, Topotecan, Vincristine)
Last Posted Update2025-07-16
ClinicalTrials.gov #NCT04322318
International Sponsor
Children's Oncology Group
Principal Investigators for Canadian Sites
Alberta Children's Hospital - Dr. Victor Lewis
BC Children's Hospital - Dr. Rebecca Deyell
CancerCare Manitoba - Dr. Ashley Chopek
McMaster Children's Hospital - Dr. Uma Athale
Stollery Children's Hospital - Dr. Sarah McKillop
Western Children's Hospital - Dr. Shayna Zelcer
Children's Hospital of Eastern Ontario (CHEO) - Dr. Donna Johnston
Hospital for Sick Children - Dr. Daniel Morgenstern
Montreal Children's Hospital - Dr. Jitka Stankova
CHU Quebec - Dr. Bruno Michon
CHU Ste. Justine - Dr. Yvan Samson
IWK Health Centre - Dr. Craig Erker
Janeway Hospital - Dr. Lisa Goodyear
CHU Sherbrooke - Dr. Josée Brossard
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. Carol Portwine
 
Social worker/patient navigator contact
Jane Cassano 
 
Clinical research contact
Sabrina Millson
 
 
Medical contact
Dr. Donna Johnston
 
Dr. Lesleigh Abbott
 
Dr. Nirav Thacker
 
Social worker/patient navigator contact
Sherley Telisma
 
Clinical research contact
Isabelle Laforest
 
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. Victor Lewis

 

Social worker/patient navigator contact
Wendy Pelletier
Clinical research contact
Debra Rich
Medical contact
Raoul Santiago
 
Social worker/patient navigator contact
Isabelle Audet
 
Clinical research contact
Barbara Desbiens
 

 

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. 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
Dr. Paul Moorehead
 
Social worker/patient navigator contact
Stephanie Eason
 
Clinical research contact
Bev Mitchell
 
Medical contact
Dr. Josee Brossard 
Social worker/patient navigator contact
Please Contact Site Directly
 
Clinical research contact
Please Contact Site Directly 
 

 

 

Study Description

In this study, researchers want to find out if

  • they can improve treatment for participants with newly diagnosed diffuse anaplastic Wilms tumour (DAWT). In hopes of finding a better therapy to fight against the cancer, participants will be given chemotherapy drugs and radiation therapy in this study. The chemotherapy drugs that participants will be receiving are often given to fight against cancer and together, the treatment is known as Regimen UH-3. This study looks at how well Regimen UH-3 works when given to children and young adults with newly diagnosed DAWT.
  • they can improve treatment for participants with "standard risk" favourable histogy Wilms tumour (FWHT) that has come back (relapsed). In hopes of finding a better therapy to fight against the cancer, participants will be given chemotherapy drugs and radiation therapy in this study. The chemotherapy drugs that participants will be receiving are often given to fight against cancer and together, the treatment is known as Regimen UH-3. This study looks at how well Regimen UH-3 works when given to children and young adults with "standard risk" favourable histogy Wilms tumour (FWHT) that has come back (relapsed).
  • they can improve treatment for participants with "high-risk or very high-risk" favourable histogy Wilms tumour (FWHT) that has come back (relapsed). In hopes of finding a better therapy to fight against the cancer you have, participants will be given chemotherapy drugs and radiation therapy in this study. The chemotherapy drugs that participants will be receiving are often given to fight cancer and together, the regimen is known as Regimen ICE/Cyclo/Topo. This study looks at how well this regimen works when given to children and young adults with "high-risk or very high-risk" favourable histogy Wilms tumour (FWHT) that has come back (relapsed).

Drugs used in chemotherapy regimens work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

 

Inclusion Criteria
  • Age less than 30 years
  • New diagnosis of diffuse anaplastic Wilms tumour
  • OR a diagnosis of Wilms tumour at first relapse (tumour that has come back, and must have been "favourable histology" at initial diagnosis)
  • Patient must be capable of all self care - such that they are out of bed >50% of day
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

NMTRC014 - NMTT- Neuroblastoma Maintenance Therapy Trial Using Difluoromethylornithine (DFMO)

Open

NMTRC014 - NMTT- Neuroblastoma Maintenance Therapy Trial Using Difluoromethylornithine (DFMO)

Go to Health Care Provider version

DiagnosisNeuroblastomaStudy StatusOpen
PhaseII
AgeChild, Adult - (1 Year to 30 Years )RandomisationNO
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment AdministrationDFMO - oral Other drugs are given as usually administered for neuroblastoma therapy.
Last Posted Update2025-07-16
ClinicalTrials.gov #NCT02679144
International Sponsor
Giselle Sholler
Principal Investigators for Canadian Sites
CHU Ste-Justine - Dr. Pierre Tiera
CHU de Quebec - Dr. Bruno Michon
CHU Sherbrooke - Dr. Josée Brossard
Montreal Children's Hospital – Dr. Jitka Stankova
Alberta Children's Hospital – Dr. Melanie Finkbeiner
CancerCare Manitoba – Dr. Ashley Chopek
Janeway Hospital - Dr. Paul Moorehead
Centres
Medical contact
Dr. Victor Lewis

 

Social worker/patient navigator contact
Wendy Pelletier
Clinical research contact
Debra Rich
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. Magimairajan Vanan
Social worker/patient navigator contact
Rhéanne Bisson
 
Clinical research contact
Rebekah Hiebert
Megan Ridler
Kathy Hjalmarsson

 

 

Medical contact
Dr. Paul Moorehead
 
Social worker/patient navigator contact
Stephanie Eason
 
Clinical research contact
Bev Mitchell
 
Medical contact
Dr. Josee Brossard 
Social worker/patient navigator contact
Please Contact Site Directly
 
Clinical research contact
Please Contact Site Directly 
 

 

 

Study Description

This study uses a drug called Difluoromethylornithine (DFMO) for patients with neuroblastoma in remission to assess the effectiveness of preventing recurrence. The study also looks at the side effects associated with these medication. DFMO is a medication taken by mouth. It is an blocker of ornithine decarboxylase, an enzyme involved with polyamine biosynthesis in the cancer cells, including neuroblastoma cells. 

Inclusion Criteria
  • Patients less than 30 years of age, with high-risk neuroblastoma in complete remission. 

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

Go to Health Care Provider version

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
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

Go to Health Care Provider version

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

Go to Health Care Provider version

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

Go to Health Care Provider version

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
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

AC220-A-U202-ADVL1822 - A Phase 1/2, Multicenter, Dose-Escalating Study To Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy Of Quizartinib Administered in Combination With Re-Induction Chemotherapy, and as a Single-Agent Continuation Therapy, in Pediatric Relapsed/Refractory AML Subjects Aged 1 Month to <18 Years (and Young Adults Aged up to 21 Years) With FLT3-ITD Mutations

Open

AC220-A-U202-ADVL1822 - A Phase 1/2, Multicenter, Dose-Escalating Study To Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy Of Quizartinib Administered in Combination With Re-Induction Chemotherapy, and as a Single-Agent Continuation Therapy, in Pediatric Relapsed/Refractory AML Subjects Aged 1 Month to <18 Years (and Young Adults Aged up to 21 Years) With FLT3-ITD Mutations

Go to Health Care Provider version

DiagnosisAcute Myeloid Leukemia, AMLStudy StatusOpen
PhaseI/II
AgeChild, Adult - (1 Month to 21 Years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationQuizartinib by mouth; other drugs are given as usually administered for leukemia therapy.
Last Posted Update2025-07-16
ClinicalTrials.gov #NCT03793478
International Sponsor
Daiichi Sankyo, Inc.
Principal Investigators for Canadian Sites
Montreal Children's Hospital – Dr. Sharon Abish
The Hospital for Sick Children - Dr. Jim Whitlock
BC Children's Hospital - Dr. Rebecca Deyell
Centres
Medical contact
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 
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

 

 

 

Study Description

This study is to find the appropriate dose as well as to assess the safety and effectiveness of a drug called quizartinib for children with relapsed or refractory acute myeloid leukemia (AML) with a certain mutation called FLT3-ITD. Quizartinib is a drug designed to specifically block the FLT3 protein when it is abnormal in a leukemia cell.

Inclusion Criteria
  • Children 1 month to 21 years of age
  • Acute myeloid leukemia that has come back or is not responding to current treatment
  • Presence of the FLT3-ITD mutation in the leukemia
  • 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

Go to Health Care Provider version

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
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






     
  •  
  •  
  •