Canadian clinical trial registry

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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. 

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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

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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

 This study is eligible for STEP-1 funding. Find more information here. 

This is an early-phase clinical trial testing a new kind of treatment called CLIC-2201. It uses a patient’s own immune cells, which are specially modified to better recognize and fight certain types of cancer that affect B cells. This treatment is being offered to patients whose cancer has come back or has not responded to other treatments.

Inclusion Criteria

Cohort A (B cell lymphoma):

• Must be 18 years of age or older of age at time of consent
• You have B cell lymphoma that has come back or hasn’t gotten better with other treatments
• You’ve already tried at least two treatments, or had a stem cell transplant, or CAR-T therapy before
• You meet the necessary organ function and bloodwork requirements 
• You must be up and about at least half of your waking hours 
• If you could become pregnant or get someone pregnant, you agree to use birth control for a year after the treatment

Cohort B (B-ALL):

• Must be between 1 and 21 years old, and you (and/or your parent or guardian) agree to join the study
• You have B-cell acute lymphoblastic leukemia (B-ALL) that has come back or hasn’t gotten better with other treatments.
• You’ve already tried at least two treatments, or had a stem cell transplant, or CAR-T therapy before
• If you had a treatment that targeted CD22, your cancer must still show signs of that marker
• You meet the necessary organ function and bloodwork requirements 
• You must be up and about at least half of your waking hours 
• If you could become pregnant or get someone pregnant, you agree to use birth control for a year after the treatment
• You are okay with a bone marrow biopsy before starting the study

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

Publications

Both Cohorts A and B

• Any uncontrolled or serious active infection at the time of enrolment.
• Active autoimmune disease requiring immunosuppressive therapy within 4 weeks of enrolment.
• Live vaccine ≤6 weeks prior to enrolment
• Active Graft Versus Host Disease (GVHD) requiring systemic immunosuppressive therapy within 4 weeks of enrolment.
• Treatment with any of the following in the specified time period before leukapheresis:
  • Allogeneic HCT within 3 months,
  • Autologous HCT within 3 months,
  • CD19 CAR-T cell infusion within 3 months,
  • Donor lymphocyte infusion (DLI) within 3 months,
  • Bendamustine within the last 6 months,
  • Any investigational agent within 30 days or 5 half-lives (whichever is shorter),
  • Systemic administration of therapeutic dose corticosteroids (>20 mg/day prednisone or equivalent for adults and ≥ 12 mg/m2/day for paediatric participants) within 7 days prior to leukapheresis.
  • Immunosuppressive therapies (i.e., calcineurin inhibitors, methotrexate, mycophenolate, rapamycin) within 4 weeks.
  • Oral chemotherapy agents (i.e., venetoclax) within 5 half-lives. An exception to this is that bruton tyrosine kinase (BTK) inhibitors like ibrutinib can be continued in participants with mantle cell lymphoma throughout the trial period.
• Other concurrent malignancy or a prior malignancy treated within the past 2 years, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease.
• Concomitant genetic syndrome associated with bone marrow failure such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure or immunodeficiency syndrome.
• Active (confirmed by PCR) hepatitis B or hepatitis C at time of screening confirmed by PCR.
• Any Human Immunodeficiency Virus (HIV) infection at time of screening.
• Hypersensitivity to fludarabine or cyclophosphamide.
• Any allergy to gentamycin or its derivatives
• Pregnant or nursing participants.

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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.