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.

88 results found

Title
Status

 

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.

BT016C - HIFU - A Safety and Feasibility Study to Evaluate Blood Brain Barrier Disruption Using Exablate MR Guided Focused Ultrasound in Combination With Doxorubicin in Treating Pediatric Patients With Diffuse Intrinsic Pontine Gliomas (DIPG)

Open

BT016C - HIFU - A Safety and Feasibility Study to Evaluate Blood Brain Barrier Disruption Using Exablate MR Guided Focused Ultrasound in Combination With Doxorubicin in Treating Pediatric Patients With Diffuse Intrinsic Pontine Gliomas (DIPG)

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DiagnosisBrain TumorStudy StatusOpen
PhaseI/II
Age5 Years to 18 YearsRandomisationNO
Line of treatmentFirst line treatment
Routes of Treatment AdministrationDevice: Exablate Model 4000 Type 2.0/2.1 Drug: Doxorubicin
Last Posted Update2023-06-26
ClinicalTrials.gov #NCT05615623
International Sponsor
InSightec
Principal Investigators for Canadian Sites
The Hospital for Sick Children (SickKids) - Dr. James Rutka
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 purpose of this study is to evaluate the safety and efficacy of combining Focused Ultrasound (Exablate Model 4000 Type 2.0/2.1) with Doxorubicin therapy for the treatment of DIPG in pediatric patients.

Inclusion Criteria
  • Age between 5 and 18 years, inclusive
  • Patient diagnosed with DIPG
  • Must be between 4-12 weeks from completion of radiation therapy
  • Able to attend all study visits
  • Able and willing to give consent and/or assent or have a legal guardian who is able and willing to do so
  • If brain surgery occurred, at least 14 days passed since last brain surgery and the patient is fully recovered and neurologically stable

Additional inclusion and exclusion criteria may be discussed with you by the study team.

NANT2015-02 - Phase 1 Study of Lorlatinib (PF-06463922), an Oral Small Molecule Inhibitor of ALK/ROS1, for Patients With ALK-Driven Relapsed or Refractory Neuroblastoma

Closed to enrollment

NANT2015-02 - Phase 1 Study of Lorlatinib (PF-06463922), an Oral Small Molecule Inhibitor of ALK/ROS1, for Patients With ALK-Driven Relapsed or Refractory Neuroblastoma

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DiagnosisNeuroblastomaStudy StatusClosed to enrollment
PhaseI
AgeChild, Adult, Older Adult - (1 Year to 90 Years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationLorlatinib: Oral (tablet) Cyclophosphamide: IV Topotecan: IV
Last Posted Update2023-06-05
ClinicalTrials.gov #NCT03107988
International Sponsor
New Approaches to Neuroblastoma Therapy Consortium
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr.Daniel Morgenstern
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

Some neuroblastoma have a specific genetic change or mutation called an ALK aberration.  ALK, or anaplastic lymphoma kinase, has been found in several adult and pediatric cancers.  ALK aberrations are present in about 14% of newly diagnosed patients with high-risk neuroblastoma, and can be found more frequently at the time of relapse.  Lorlatinib is a drug called an ALK inhibitor. It is expected to slow or stop the growth of cancer cells which have the ALK aberration. The aim of this phase I/II study is to evaluate the dose, safety, and tolerability of lorlatinib, including the effect it has on the cancer.  Lorlatinib will be given alone or in combination with chemotherapy in children with refractory, relapsed or progressive neuroblastoma with ALK alterations.

Inclusion Criteria
  • Patients must have a diagnosis of neuroblastoma either by histologic verification (looking at a sample of the tumour under a microscope) of neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamines (HVA/VMA).
  • Patients are required to have an activating ALK aberration in their tumor, which is identified through genetic testing.
  • Patients must have high risk neuroblastoma. Patients who were initially considered low or intermediate risk, but then reclassified as high risk are also eligible.
  • Patients must have at least ONE of the following: 1) Recurrent/progressive disease at any time prior to study enrollment, 2) Refractory disease, 3) Persistent disease

 

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