Canadian clinical trial registry

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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

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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

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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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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.

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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. 

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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

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Study Description

In this study, researchers are trying to learn more about how safe the study medicine called Alectinib is, and how well they work for children and young people with certain solid or brain cancers where previous treatment has not worked or is not available.

Inclusion Criteria

• Patients must have a confirmed diagnosis of a brain tumour or solid tumor with a specific gene change called "ALK fusion"
• Patients must have a cancer that has come back (relapsed) or has no standard treatment available
• Patients must be 17 years old or younger to participate 
• Patients must be able to walk and do routine activities for more than half of their normal waking hours
• Patients must have a willingness to complete clinical assessments throughout the study (electronic, paper and/or interviewer methods)

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

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Study Description

MEKTOVI (binimetinib) is a medicine taken by mouth that helps block certain signals in the body that make some tumors grow. In this Phase II study, the drug will be used to treat children diagnosed with Adamantinomatous Craniopharyngioma (ACP), a type of brain tumor. This tumor can be very challenging to treat, and current options like surgery and radiation can affect the patient's quality of life, especially when the tumor comes back.

Recent research shows that ACP might respond to medicines like binimetinib that block specific pathways in the body.

Up to 38 children will take binimetinib in pill form, twice a day for 4 weeks (1 cycle), and treatment could continue for up to two years. The trial will include children aged 1 to 25, some of whom have already had radiation therapy.

The goal is to see if this medicine can help control the tumor and improve their quality of life.

Inclusion Criteria

• Patients must be between 1 and 25 years old.
• Must have a confirmed Adamantinomatous Craniopharyngioma (ACP), either from a solid tumor or cyst fluid.
• Must have a measurable tumor that can be seen on scans:
  • Stratum 1: Patients whose tumor came back or got worse at least 6 months after finishing radiation therapy.
  • Stratum 2: Patients who have had surgery but have not had radiation (they may have had other treatments before).
• Patients must be able to do at least half of their usual activities, even if they use a wheelchair.
• Must have recovered from any side effects of previous treatments.
• Previous Treatments:
  • At least 7 days since the last dose of any biologic treatment (anti-tumor therapy).
  • At least 42 days since any immunotherapy (e.g. cancer vaccines).
  • At least 21 days since a monoclonal antibody treatment.
  • At least 6 months since focused radiation and no history of radiation to the whole brain/spine.
  • Corticosteroids: If on dexamethasone, the dose must be stable or reducing for at least 1 week.
  • Chemotherapy: At least 21 days since the last round of chemotherapy.
  • Surgery: At least 6 weeks since any surgery.
• Blood counts and organ function requirements must meet certain safety levels before treatment.
• Patient and/or their parent/guardian must agree to join the study by signing a consent form.

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

Publications

• Foreman NK, Faestel PM, Pearson J, Disabato J, Poole M, Wilkening G, Arenson EB, Greffe B, Thorne R. Health status in 52 long-term survivors of pediatric brain tumors. J Neurooncol. 1999 Jan;41(1):47-53. doi: 10.1023/a:1006145724500.
• Goldman S, Pollack IF, Jakacki RI, Billups CA, Poussaint TY, Adesina AM, Panigrahy A, Parsons DW, Broniscer A, Robinson GW, Robison NJ, Partap S, Kilburn LB, Onar-Thomas A, Dunkel IJ, Fouladi M. Phase II study of peginterferon alpha-2b for patients with unresectable or recurrent craniopharyngiomas: a Pediatric Brain Tumor Consortium report. Neuro Oncol. 2020 Nov 26;22(11):1696-1704. doi: 10.1093/neuonc/noaa119.
• Apps JR, Carreno G, Gonzalez-Meljem JM, Haston S, Guiho R, Cooper JE, Manshaei S, Jani N, Holsken A, Pettorini B, Beynon RJ, Simpson DM, Fraser HC, Hong Y, Hallang S, Stone TJ, Virasami A, Donson AM, Jones D, Aquilina K, Spoudeas H, Joshi AR, Grundy R, Storer LCD, Korbonits M, Hilton DA, Tossell K, Thavaraj S, Ungless MA, Gil J, Buslei R, Hankinson T, Hargrave D, Goding C, Andoniadou CL, Brogan P, Jacques TS, Williams HJ, Martinez-Barbera JP. Tumour compartment transcriptomics demonstrates the activation of inflammatory and odontogenic programmes in human adamantinomatous craniopharyngioma and identifies the MAPK/ERK pathway as a novel therapeutic target. Acta Neuropathol. 2018 May;135(5):757-777. doi: 10.1007/s00401-018-1830-2. Epub 2018 Mar 14.
• Haston S, Pozzi S, Carreno G, Manshaei S, Panousopoulos L, Gonzalez-Meljem JM, Apps JR, Virasami A, Thavaraj S, Gutteridge A, Forshew T, Marais R, Brandner S, Jacques TS, Andoniadou CL, Martinez-Barbera JP. MAPK pathway control of stem cell proliferation and differentiation in the embryonic pituitary provides insights into the pathogenesis of papillary craniopharyngioma. Development. 2017 Jun 15;144(12):2141-2152. doi: 10.1242/dev.150490. Epub 2017 May 15.
• Bendell JC, Javle M, Bekaii-Saab TS, Finn RS, Wainberg ZA, Laheru DA, Weekes CD, Tan BR, Khan GN, Zalupski MM, Infante JR, Jones S, Papadopoulos KP, Tolcher AW, Chavira RE, Christy-Bittel JL, Barrett E, Patnaik A. A phase 1 dose-escalation and expansion study of binimetinib (MEK162), a potent and selective oral MEK1/2 inhibitor. Br J Cancer. 2017 Feb 28;116(5):575-583. doi: 10.1038/bjc.2017.10. Epub 2017 Feb 2.
• Watanabe K, Otsu S, Hirashima Y, Morinaga R, Nishikawa K, Hisamatsu Y, Shimokata T, Inada-Inoue M, Shibata T, Takeuchi H, Watanabe T, Tokushige K, Maacke H, Shiaro K, Ando Y. A phase I study of binimetinib (MEK162) in Japanese patients with advanced solid tumors. Cancer Chemother Pharmacol. 2016 Jun;77(6):1157-64. doi: 10.1007/s00280-016-3019-5. Epub 2016 Apr 12.
• Patel K, Allen J, Zagzag D, Wisoff J, Radmanesh A, Gindin T, Nicolaides T. Radiologic response to MEK inhibition in a patient with a WNT-activated craniopharyngioma. Pediatr Blood Cancer. 2021 Mar;68(3):e28753. doi: 10.1002/pbc.28753. Epub 2020 Oct 19. No abstract available.