Canadian clinical trial registry

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Study Description

(As seen on the Australian & New Zealand Childrens Haematology/Oncology Group website - https://anzchog.org/clinic-trails/connect-1903-a-pilot-and-surgical-study-of-larotrectinib-for-treatment-of-children-with-newly-diagnosed-high-grade-glioma-with-ntrk-fusion/ )

Recent research shows that a new oral tablet drug, larotrectinib, has produced promising results by shrinking some solid tumours that have an abnormal or mutated NTRK gene in adults and children.

High grade gliomas (HGG) are fast growing, aggressive brain cancers and if they recur after initial treatment, there are no effective treatment options. This study will investigate if larotrectinib alone as well as Larotrectinib  in combination with chemotherapy or radiotherapy can  be of benefit in children with high grade gliomas with the mutated NTRK gene. This international trial will study how well the drug is tolerated and its effectiveness to shrink these tumours when used alone or when given with standard chemotherapy or after radiation.

Inclusion Criteria

(As seen on the Australian & New Zealand Childrens Haematology/Oncology Group website - https://anzchog.org/clinic-trails/connect-1903-a-pilot-and-surgical-study-of-larotrectinib-for-treatment-of-children-with-newly-diagnosed-high-grade-glioma-with-ntrk-fusion/ )

• Patient must be 21 years old or younger and newly diagnosed with high grade glioma (HGG)
• The tumour must have a genetic anomaly called an NTRK fusion for the patient to qualify
• 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 test the safety of a cancer drug called repotrectinib in children. The cancer must have a change in a particular gene (ALK, ROS1 or NTRK). Those gene changes lead to abnormal proteins which may cause cancer cells to grow. Repotrectinib blocks the actions of these genes in cancer cells and can therefore be used to treat cancer.

The first study part (Phase 1) is done to determine what dose level of repotrectinib is safe for children, how the drug is absorbed. This phase is now closed.

The main purpose of the second study part (Phase 2) is to investigate how well and how long different cancer types respond to the treatment with repotrectinib.

This study is divided into 2 stages/phases.

The first stage or phase evaluates the safety and tolerability of the drug (repotrectinib) in patients with advanced cancers. This allows researchers to determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) which can then be used to select the recommended dose for patients. This phase is now closed.

The second stage or phase will determine the effectiveness of the drug (repotrectinib) in treating advanced cancers.

Inclusion Criteria

For the first phase:

• Age <12 years
• Patients with advanced or metastatic cancer, including brain tumours or certain types of lymphoma
• The tumour must have a change in one of the following genes: ALK, ROS1 or NTRK
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

For the second phase:

• Age 12 to less than 25 years
• Patients with advanced or metastatic cancer, including brain tumours or certain types of lymphoma
• The tumour must have a change in one of the following genes: ALK, ROS1 or NTRK
• Some patients may be eligible even if they have already received another drug blocking NTRK in the past
• 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 find out what effects new combinations of treatment will help in treating a cancer called lymphoma. New promising treatment strategies will be added to this study as they are available to be compared against the standard treatment.

Inclusion Criteria

• Participants must be between 16 to 65 years old to participate
• Participants must have one of the following diagnoses: 
  • Diffuse large cell lymphoma, B-cell (includes primary mediastinal B-cell lymphoma, T-cell rich B-cell lymphoma)
  • Previous indolent lymphoma with transformation to diffuse large B-cell lymphoma at most recent relapse
  • Unclassifiable B-cell lymphoma with indeterminate features between diffuse large B-cell lymphoma and Burkitt lymphoma
• Participants must have the presence of a protein called CD20
• Must meet all bloodwork requirements
• Participants who can bare children must have a negative pregnancy test prior to starting 
• Participants must be willing to sign a consent form and agree to the study schedule

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

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Study Description

This clinical trial studies the side effects of a medication called CLR131. This medication is a targeted radiopharmaceutical, which means it acts like radiation therapy, but is given intravenously as an infusion. 

CLR 131 is designed to target cells with cancer rather than cells without cancer. The main goal of this study is to determine what is the safe amount of medication to give to children with cancer that has come back or is not responding to treatment.

Inclusion Criteria

• Age between 10 and 25 years
• High Grade Glioma that has come back (relapse) or not improved despite treatment (progression)
• Must meet all bloodwork requirements
• Patient must be up and about at least 60% of their waking hours
• Patient must be willing to comply with study visit requirements and sign a consent form 

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

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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.

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Study Description

This study evaluates how effective a drug called plixorafenib is in participants with solid tumors or central nervous system (CNS) tumors with a genetic mutation called a BRAF fusion/BRAF V600E mutation that have progressed or come back.

Inclusion Criteria

• Male and female, ≥10 years of age, and weighing ≥30 kg.
• Diagnosis of a solid tumor or primary CNS tumor that has previously been treated with other standard therapies
• Documentation of BRAF gene fusion in tumor
• Willingness to provide informed consent and comply with study requirements 

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

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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

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Study Description

This is a phase 3 study for patients with newly diagnosed diffuse glioma. To be eligible for this study, the participant's cancer must have a mutation called H3 K27M. This study explores whether adding treatment with the experimental drug called ONC201 after radiotherapy is effective in patients with this type of cancer. 

Inclusion Criteria

• Able to understand the study procedures and agree to participate in the study by providing written informed consent and assent when applicable.
• Body weight ≥ 10 kg
• A new diagnosis of diffuse glioma with a H3 K27M mutation 
• Received frontline radiotherapy (radiation) within 2-6 weeks of starting this study
• Patient must be capable of self-care but may be unable to engage in normal activities or perform active work

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