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.

89 results found

Title
Status

 

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

Open

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 StatusOpen
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 Update2023-10-18
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

ANBL1821 - A Phase 2 Randomized Study of Irinotecan/Temozolomide/Dinutuximab With or Without Eflornithine (DFMO) in Children With Relapsed, Refractory or Progressive Neuroblastoma

Open

ANBL1821 - A Phase 2 Randomized Study of Irinotecan/Temozolomide/Dinutuximab With or Without Eflornithine (DFMO) in Children With Relapsed, Refractory or Progressive Neuroblastoma

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DiagnosisHigh Risk, Recurrent, or Refractory NeuroblastomaStudy StatusOpen
PhaseII
Age1 Year and olderRandomisationYES
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationBiological: Dinutuximab (Given Intravenous (IV)) Drug: Irinotecan Hydrochloride (Given Intravenous (IV)) Biological: Sargramostim (Given Intravenous (IV) or Subcutaneous (SC)) Drug: Temozolomide (Given orally or via NG or G tube) Drug: Eflornithine Hydrochloride (Given orally or via NG or G tube) may or may not be given
Last Posted Update2023-09-28
ClinicalTrials.gov #NCT03794349
International Sponsor
Children's Oncology Group
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Daniel Morgenstern
CancerCare Manitoba - Dr. Ashley Chopek
CHU Quebec - Dr. Bruno Michon
CHU Sherbrooke - Dr. Josée Brossard
Hamilton Health Sciences Centre (McMaster) - Dr. Uma H. Athale
IWK Health Centre - Dr. Craig Erker
Montreal Children's Hospital - Dr. Sharon Abish
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. Magimairajan Vanan
Social worker/patient navigator contact
Rhéanne Bisson
 
Clinical research contact
Rebekah Hiebert
Megan Ridler
Kathy Hjalmarsson

 

 

Medical contact
Raoul Santiago
 
Social worker/patient navigator contact
Isabelle Audet
 
Clinical research contact
Barbara Desbiens
 

 

Medical contact
Dr. Carol Portwine
 
Social worker/patient navigator contact
Jane Cassano 
 
Clinical research contact
Sabrina Millson
 
 
Medical contact
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 
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. Josee Brossard 
Social worker/patient navigator contact
Please Contact Site Directly
 
Clinical research contact
Please Contact Site Directly 
 

 

 

Study Description

This is a phase II study to treat patients with neuroblastoma that has come back (relapsed) or is not responding to previous treatment (refractory). This study is seeing if combining eflornithine (a drug used to block the production of chemicals that may cause growth of cancer cells) with drugs used in chemotherapy/immunotherapy (irinotecan hydrochloride, temozolomide, sargramostim and dinutuximab) may work better in treating patients with relapsed or refractory neuroblastoma compared to using irinotecan hydrochloride, temozolomide, sargramostim and dinutuximab alone. Patients will be randomly assigned to 1 of 2 regimens, one regimen will recieve eflornithine with the chemotherapy/immunotherapy drugs and the other regimen will recieve chemotherapy/immunotherapy drugs without eflornithine.

Inclusion Criteria
  • Patients must have a neuroblastoma that has come back, progressed or not responded to previous treatment
  • Patients must be 1 year of age or older
  • Patients must be up and about at least 50% of their waking hours
  • 14 days must have passed if patients have recieved any treatment that supresses bone marrow
  • >= 21 days must have passed from infusion of antibodies
  • Patients must not have received radiation for a minimum of 4 weeks before joining the study. Palliative radiation while on study is not permitted.
  • Blood work must come back within the acceptable ranges
  • Patients must have no evidence of shortness of breath, and no need for supportive oxygen 
  • Patients with a history of central nervous system (CNS) disease must have no evidence of active CNS disease at the time of study enrollment
  • Patients with seizure disorders may be enrolled if seizures are well controlled on proper medication
  • Patients of childbearing potential must have a negative pregnancy test to be eligible for this study and must agree to use adequate contraception while enrolled on this study.

Other inclusion and exclusion criteria may apply and will be reviewed by your treating team.

SNDX-5613-0700 - AUGMENT-101: A Phase 1/2, Open-label, Dose-Escalation and Dose-Expansion Cohort Study of SNDX 5613 in Patients With Relapsed/Refractory Leukemias, Including Those Harboring an MLL/KMT2A Gene Rearrangement or Nucleophosmin 1 (NPM1) Mutation

Open

SNDX-5613-0700 - AUGMENT-101: A Phase 1/2, Open-label, Dose-Escalation and Dose-Expansion Cohort Study of SNDX 5613 in Patients With Relapsed/Refractory Leukemias, Including Those Harboring an MLL/KMT2A Gene Rearrangement or Nucleophosmin 1 (NPM1) Mutation

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DiagnosisAcute Myeloid Leukemia Acute Lymphoblastic Leukemia Mixed Lineage Acute Leukemia Mixed Phenotype Acute Leukemia Acute Leukemia of Ambiguous LineageStudy StatusOpen
PhaseI/II
Ageup to 18 YearsRandomisationNO
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment AdministrationDrug: SNDX-5613 (given orally) Drug: Cobicistat (Patients in Phase 1 Arm C patients will receive 150 mg cobicistat daily)
Last Posted Update2023-09-28
ClinicalTrials.gov #NCT04065399
International Sponsor
Syndax Pharmaceuticals
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

This is a phase I/II study that studies the drug SNDX-5613 in patients with acute leukemia. In phase 1, the dose will be increased to find the maximum tolerated dose of SNDX-5613 and the recommended dose for the next phase will be determined. In phase 2, patients will be given the recommended phase 2 dose determined in phase 1, and the safety and efficacy in patients with various tumour mutation will be studied. 

Inclusion Criteria
  • Patients must have active acute leukemia with certain genetic characteristics
  • Patients must be over 30 days old 
  • Patients must be up and about more than 50% of waking hours (if applicable)
  • Adequate time must have passed from all previous treatments (i.e at least 60 days must have passed from last radiation treatment/stem cell infusion (if applicable))
  • Adeqaute organ function
  • Blood work must come back within acceptable ranges
  • Patients of child bearing potential must be willing to use a highly effective method of contraception from the time of enrollment to 120 days after the last study drug dose
  • Patients and/or their families/caregivers must sign a consent form outlining all assessments and requirements

DAY101-001 (FIREFLY-1) - FIREFLY-1: A Phase 2, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of the Oral Pan-RAF Inhibitor DAY101 in Pediatric Patients With BRAF-Altered, Recurrent or Progressive Low-Grade Glioma

Open

DAY101-001 (FIREFLY-1) - FIREFLY-1: A Phase 2, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of the Oral Pan-RAF Inhibitor DAY101 in Pediatric Patients With BRAF-Altered, Recurrent or Progressive Low-Grade Glioma

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DiagnosisLow-grade glioma or solid tumors with RAF alterationsStudy StatusOpen
PhaseII
AgeChild, Adult - (6 Months to 25 Years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDay101: oral (tablet formulation)
Last Posted Update2023-09-28
ClinicalTrials.gov #NCT04775485
International Sponsor
Day One Biopharmaceuticals, Inc.
Principal Investigators for Canadian Sites
Montreal Children's Hospital – Dr. Nada Jabado
CHU Ste-Justine – Dr. Sebastien Perreault
CHU de Quebec – Dr. Valerie Larouche

Centres
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
 

 

 

 

Study Description

The purpose of this study is to see if the experimental drug DAY101 is safe and effective in treating recurrent or progressive (tumor that has come back or isn’t improving despite treatment) glioma or solid tumors in pediatric, adolescent and young adult patients. The drug will be given in the form of oral tablets.

Inclusion Criteria
  • Age between 6 months to 25 years
  • Patient must be diagnosed with low grade glioma or solid tumor, that isn’t improving despite treatment 
  • The tumour must display a genetic change called a "RAF alteration"
  • Patient must be able to swallow oral tablets
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

2215-CL-0603 (ASP2215) - A Phase 1/2, Multicenter, Open-Label, Single Arm, Dose Escalation and Expansion Study of Gilteritinib (ASP2215) Combined With Chemotherapy in Children, Adolescents and Young Adults With FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

Open

2215-CL-0603 (ASP2215) - A Phase 1/2, Multicenter, Open-Label, Single Arm, Dose Escalation and Expansion Study of Gilteritinib (ASP2215) Combined With Chemotherapy in Children, Adolescents and Young Adults With FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

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DiagnosisAcute Myeloid LeukemiaStudy StatusOpen
PhaseI/II
AgeChild, Adult - (6 Months to 21 Years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationOral for gilteritinib ; other drugs as usually administered for leukemia therapy
Last Posted Update2023-09-28
ClinicalTrials.gov #NCT04240002
International Sponsor
Astellas Pharma Global Development, Inc.
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 is a study of a new oral medication called gilteritinib, to be given in combination with chemotherapy to patients that have acute myeloid leukemia that has come back (relapse). The leukemia cells need to have a genetic change called "FLT3 ITD" for the patient to be considered for the study. Gilteritinib is an anti-cancer medication that blocks the FLT3 protein when it is abnormal in a leukemia cell.

The main goal of the study will be to establish an optimally safe and biologically active dose of the medication, and then to determine the effect it has on leukemia disease in combination with chemotherapy.

Inclusion Criteria
  • Age from 6 months to 21 years
  • Acute myeloid leukemia that has come back (relapse) and has a genetic change called "FLT3 ITD"
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

D0816C00025 - A Phase I, Open-label, Parallel Group Study to Investigate Olaparib Safety and Tolerability, Efficacy and Pharmacokinetics in Paediatric Patients With Solid Tumours

Open

D0816C00025 - A Phase I, Open-label, Parallel Group Study to Investigate Olaparib Safety and Tolerability, Efficacy and Pharmacokinetics in Paediatric Patients With Solid Tumours

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DiagnosisSolid TumoursStudy StatusOpen
PhaseI
Age6 Months to 18 Years RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: Olaparib (Oral)
Last Posted Update2023-09-28
ClinicalTrials.gov #NCT04236414
International Sponsor
AstraZeneca
Principal Investigators for Canadian Sites
Montreal Children's Hospital - Dr. Sharon Abish
Centres
Medical contact
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 

 

 

Study Description

This is a study to find out whether a drug called olaparib (also called a PARP inhibitor) is safe and well tolerated when administered to children and adolescents with solid tumours or brain tumours, when they have come back or are not improving with treatment.

Inclusion Criteria
  • Patients are ≥ 6 months to <18 years of age 
  • Patients have a solid tumour or brain tumour that has come back (relapsed) or is not improving with treatment (refractory)  
  • There is a gene change in the tumour or in the normal cells of the patient that can be called "homologous recombination repair gene mutation"
  • The patient can swallow tablets
  • Multiple other inclusion criteria could apply and will be reviewed by your treating team.

ARST2031 - A Randomized Phase 3 Trial of Vinorelbine, Dactinomycin, and Cyclophosphamide (VINO-AC) Plus Maintenance Chemotherapy With Vinorelbine and Oral Cyclophosphamide (VINO-CPO) vs Vincristine, Dactinomycin and Cyclophosphamide (VAC) Plus VINO-CPO Maintenance in Patients With High Risk Rhabdomyosarcoma (HR-RMS)

Open

ARST2031 - A Randomized Phase 3 Trial of Vinorelbine, Dactinomycin, and Cyclophosphamide (VINO-AC) Plus Maintenance Chemotherapy With Vinorelbine and Oral Cyclophosphamide (VINO-CPO) vs Vincristine, Dactinomycin and Cyclophosphamide (VAC) Plus VINO-CPO Maintenance in Patients With High Risk Rhabdomyosarcoma (HR-RMS)

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DiagnosisRhabdomyosarcomaStudy StatusOpen
PhaseIII
Ageup to 50 YearsRandomisationYES
Line of treatmentFirst line treatment
Routes of Treatment AdministrationChemotherapy medications (Cyclophosphamide, Dactinomycin, Vincristine, Vinorelbine), all given intravenously, except for cyclophosphamide that will be taken by mouth too Patients will also receive radiation therapy when participating to this study.
Last Posted Update2023-09-28
ClinicalTrials.gov #NCT04994132
International Sponsor
Children's Oncology Group
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Paul Nathan
Hamilton Health Sciences Centre - Dr. Uma H. Athale
Children’s Hospital of Eastern Ontario (CHEO) - Dr. Donna L. Johnston
Children's Hospital of Western Ontario – Dr. Shayna Zelcer

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. Carol Portwine
 
Social worker/patient navigator contact
Jane Cassano 
 
Clinical research contact
Sabrina Millson
 
 
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. Alexandra Zorzi
Dr. Shayna Zelcer
 
Social worker/patient navigator contact
Cindy Milne Wren
Jessica Mackenzie Harris
 
Clinical research contact
Mariam Mikhail

 

 

Study Description

This phase III trial compares the effect of two chemotherapy drug pathways (vinorelbine with vincristine, dactinomycin, and cyclophosphamide (VAC) followed by vinorelbine and cyclophosphamide versus VAC followed by vinorelbine and cyclophosphamide) for the treatment of high risk rhabdomyosarcoma.

Chemotherapy drugs, such as vinorelbine, vincristine, dactinomycin, and cyclophosphamide, 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.

Giving vinorelbine and VAC may kill more tumor cells and adding maintenance therapy after VAC therapy may help get rid of the cancer and/or lower the chance that the cancer comes back.

Inclusion Criteria
  • Patients must be =< 50 years of age 
  • Study is open to all genders
  • Patients with newly diagnosed rhabdomyosarcoma (RMS) of any subtype, meeting "high risk" criteria
  • Various bloodwork (bilirubin, creatinine, etc) must be within an acceptable range
  • Patients must not be pregnant during the duration of the trial
  • Additional inclusion and exclusion criteria may apply and will be reviewed by the study team

PLAT-05 - Pediatric and Young Adult Leukemia Adoptive Therapy (PLAT)-05: A Phase 1 Feasibility and Safety Study of Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy for CD19+CD22+ Leukemia

Open

PLAT-05 - Pediatric and Young Adult Leukemia Adoptive Therapy (PLAT)-05: A Phase 1 Feasibility and Safety Study of Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy for CD19+CD22+ Leukemia

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DiagnosisLeukemia, ALL, Acute Lymphoblastic LeukemiaStudy StatusOpen
PhaseI
AgeChild, Adult - (up to 30 Years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationIV
Last Posted Update2023-09-28
ClinicalTrials.gov #NCT03330691
International Sponsor
Seattle Children's Hospital
Principal Investigators for Canadian Sites
BC Children's Hospital – Dr. Kirk Schultz
Centres
Medical contact
Rebecca Deyell

 

Social worker/patient navigator contact
Ilana Katz 

 

Clinical research contact
Hem/Onc/BMT Clinical Trials Unit

 

 

 

Study Description

Patients with relapsed or refractory leukemia often develop resistance to chemotherapy and some patients who relapse following CD19 directed therapy relapse with CD19 negative leukemia. For this reason, the investigators are attempting to use T-cells obtained directly from the patient, which can be genetically modified to express two chimeric antigen receptors (CARs). One is to recognize CD19 and the other is to recognize CD22, both of which are proteins expressed on the surface of the leukemic cell in patients with CD19+CD22+ leukemia. The CAR enables the T-cell to recognize and kill the leukemic cell through recognition of CD19 and CD22. This is a phase 1 study designed to determine the safety of the CAR+ T-cells and the feasibility of making enough to treat patients with CD19+CD22+ leukemia.

Inclusion Criteria
  • First 2 subjects: male and female subjects age ≥18 and < 27 years (as of 2/16/18 the first 2 subjects were enrolled and treated); subsequent subjects: male and female subjects age ≥12 months of age and <27 years.
  • Diagnosis of CD19+22+ leukemia relapsed or refractory
  • Asymptomatic from CNS involvement
  • Free from active GVHD and off immunosuppressive GVHD therapy for 4 weeks prior to enrollment
  • Recovered from acute toxic effects of all prior chemotherapy, immunotherapy, and radiotherapy
  • No prior genetically modified cell therapy that is still detectable or virotherapy
  • Willing to participate in long-term follow-up for up to 15 years, if enrolled in the study and receive T cell infusion

Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.