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Clinical Trials for Recurrent Precursor T-lymphoblastic Lymphoma/Leukaemia

There are currently 5 ongoing clinical trials investigating new treatments for patients with recurrent precursor T-lymphoblastic lymphoma/leukaemia. These studies focus on testing innovative therapies including targeted medications and modified immune cell treatments for patients whose cancer has returned or has not responded to previous treatments. The trials are being conducted across multiple European countries and Spain.

Clinical trial locations

Study of Dasatinib and Venetoclax for Children with Relapsed or Refractory Leukemia or Lymphoma with MAPK/SRC Pathway Mutation

This clinical trial is investigating a combination of two targeted medications, Venetoclax and Dasatinib, for children whose cancer has returned or not responded to previous treatments. The study focuses specifically on patients with particular genetic changes in their cancer cells related to the MAPK/SRC signaling pathway.

Main inclusion criteria: Children between 1 and 18 years old at first diagnosis, and under 21 years at study entry, can participate. Participants must be able to swallow tablets and have a performance score of at least 50% on either the Karnofsky or Lansky scale. Their cancer must show specific genetic changes such as NUP214-ABL1 fusion, other ABL1 fusions, ABL1 amplification, or PDGFRβ-fusion. Adequate kidney, liver, and heart function is required, with specific blood test results and cardiac measurements within acceptable ranges.

Main exclusion criteria: Patients with other types of cancer not related to the study, those with severe allergic reactions to similar treatments, pregnant or breastfeeding patients, those with severe heart problems or uncontrolled infections, patients who received experimental treatment within 4 weeks, and those with substance abuse history or inability to follow study procedures cannot participate.

Focus and goal: The trial is divided into two phases. The first phase aims to determine the safest dose of the medications, while the second phase evaluates how effectively the medications work in treating the cancer. The study tracks various outcomes including overall response to treatment, time until cancer returns, and quality of life for participants. Expected to continue until 2031, with recruitment starting in 2024.

Investigational drugs: The study uses Venetoclax, available as oral suspension and film-coated tablets, and Dasatinib, available as film-coated tablets and powder for oral suspension. Both medications are anti-neoplastic agents designed to target and stop the growth of cancer cells.

Study of Ruxolitinib and Venetoclax for Children with Relapsed or Refractory Leukemia or Lymphoma with IL-7R/JAK-STAT Pathway Mutations

This trial examines the combination of Venetoclax and Ruxolitinib for children with blood cancers that have either returned or not responded to treatment. The study specifically targets cases with genetic changes in the IL-7R/JAK-STAT signaling pathway, which affects cancer cell communication and growth.

Main inclusion criteria: Eligible children must be between 1 and 18 years old at first diagnosis and under 21 at study entry, with the ability to swallow tablets. A performance score of at least 50% on the Karnofsky or Lansky scale is required. Participants must have undergone molecular profiling and flow-cytometric analysis of their disease. Their cancer must show specific changes in pathways including rearrangements, mutations, or overexpression in genes like CRLF2, EPOR, JAK1/2/3, IL-7R, and others. Adequate organ function is essential, with specific requirements for kidney, liver, and heart function.

Main exclusion criteria: Patients with different cancer types, those outside the specified age range, pregnant or breastfeeding individuals, those with uncontrolled infections, certain heart problems, allergies to study drugs, or who received recent cancer treatments cannot participate. Those unable to follow study procedures are also excluded.

Focus and goal: The study consists of two phases: the first determines the safest medication dose, and the second assesses treatment effectiveness. Throughout the trial, participants receive either Venetoclax, Ruxolitinib, or both in oral form, with some possibly receiving a placebo for comparison. Close monitoring by healthcare professionals ensures patient safety and tracks condition changes. The study runs until 2031, beginning recruitment in 2024.

Investigational drugs: Both Venetoclax and Ruxolitinib are administered orally as tablets or suspensions. These medications specifically target genetic alterations in cancer cells within the IL-7R/JAK-STAT pathway.

Study on the Safety and Effectiveness of OC-1 Therapy for Patients with Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia or Lymphoma

This trial investigates a novel treatment called hCD1a-CAR T (OC-1) for patients with aggressive forms of blood cancer that have returned or not responded to previous treatments. The therapy uses the patient’s own immune cells, modified outside the body to better recognize and attack cancer cells when reintroduced into the bloodstream.

Main inclusion criteria: Both children older than 2 years and adults can participate. Patients must have CD1a antigen present in at least 20% of their cancer cells, confirmed by flow cytometry or tissue examination. Eligible patients include those with cancer relapse after stem cell transplant, primary refractoriness after two standard treatments, refractory first relapse, or second or further relapse. Participants must either be unable to have children or agree to use highly effective birth control during the study.

Main exclusion criteria: Patients with different cancer types, those outside the age range, pregnant or breastfeeding individuals, those with serious health conditions interfering with the study, recent clinical trial participants, those with allergies to study medication, and those unable to provide consent cannot participate.

Focus and goal: The study assesses the safety of this new treatment in patients with CD1a-positive cancer. Participants receive the therapy through intravenous infusion and are monitored for side effects and treatment effectiveness. The research evaluates remission rates, overall survival, and how long modified immune cells remain active in the body.

Investigational drug: The hCD1a-CAR T (OC-1) therapy involves T-cells genetically modified to recognize the CD1a marker on cancer cells, enhancing the immune system’s ability to target and destroy these cells.

Study on Trametinib, Dexamethasone, Cyclophosphamide, and Cytarabine for Children with Relapsed or Refractory Blood Cancer

This clinical trial examines a combination of medications including Trametinib, Dexamethasone, Cyclophosphamide, and Cytarabine for children with blood cancers that are either in relapse or resistant to treatment. The study explores both the safety and effectiveness of these medications in treating cancers with specific genetic changes.

Main inclusion criteria: Children between 1 and 18 years old at first diagnosis, and under 21 at study entry, can participate. They must be able to swallow tablets, with weight requirements of at least 26 kg for those under 6 years and 33 kg for those over 6 years. A performance score of at least 50% on the Karnofsky or Lansky scale is required. Patients must have undergone molecular profiling and flow-cytometric analysis. Their cancer must show RAS pathway activating mutations in genes like KRAS, NRAS, HRAS, FLT3, and others. Adequate organ function is essential, with specific requirements for kidney, liver, and heart health.

Main exclusion criteria: Patients with different cancer types, those outside the age range, pregnant or breastfeeding individuals, those with serious interfering health conditions, recent major surgery recipients, current participants in other trials, those with allergies to study drugs, individuals with certain heart problems, and those with active infections requiring treatment cannot participate.

Focus and goal: The trial has two phases: determining the safest medication dose and evaluating treatment effectiveness in patients with specific genetic changes. Medications are administered in various forms including tablets and injections over time. The study closely monitors health and progress through regular check-ups and tests, continuing until 2030.

Investigational drugs: The combination includes Dexamethasone (oral tablets), Methotrexate (spinal fluid injection), Dexamethasone sodium phosphate (intravenous), Cyclophosphamide (intravenous infusion), Cytarabine (intravenous infusion), Hydrocortisone (spinal fluid injection), Prednisolone sodium succinate (spinal fluid injection), and Trametinib (oral tablets).

Long-term Follow-up Study for Patients with Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia/Lymphoma Treated with OC-1 Cells

This study focuses on long-term monitoring of patients who have already received OC-1 cell therapy. The treatment involves modifying a patient’s own T-cells outside the body using a lentiviral vector, enabling them to develop a chimeric antigen receptor that specifically targets the CD1a protein on cancer cells. The modified cells are then infused back into the patient’s bloodstream.

Main inclusion criteria: Patients must have previously received at least one fraction of OC-1 cell investigational product. Both male and female patients from vulnerable populations can participate. The patient or their legal representative must provide signed and dated informed consent, demonstrating understanding of the study. Participants must be able to comply with all study requirements, including procedures and visits.

Main exclusion criteria: Patients with cancer types other than T-cell acute lymphoblastic lymphoma or leukemia cannot participate. Those whose cancer has not returned or is not treatment-resistant, those not positive for CD1a marker, patients who have not received OC-1 cells, and those unwilling to be monitored for 15 years after treatment are excluded.

Focus and goal: The study monitors patients for up to 15 years to check for any delayed side effects or adverse events following OC-1 cell therapy. This long-term follow-up ensures treatment safety and helps understand potential risks over time. Researchers assess various outcomes including serious side effects, development of new health issues, and overall patient survival, while checking how long the modified T-cells remain in the body and their impact on the immune system.

Investigational drug: OC-1 cells are a form of CAR-T cell therapy involving specially modified cells designed to find and attack cancer cells. The therapy is delivered through intravenous infusion directly into the bloodstream.

Summary

The five ongoing clinical trials for recurrent precursor T-lymphoblastic lymphoma/leukaemia represent different therapeutic approaches to treating this challenging condition. Three trials focus on targeted oral medications that address specific genetic mutations in cancer cells, while two trials investigate innovative CAR-T cell therapy using OC-1 cells.

Most trials are conducted across multiple European countries, with particularly strong representation in Germany, Italy, Spain, Sweden, Finland, Norway, Denmark, Netherlands, Austria, Belgium, and France. Spain stands out as the sole location for both OC-1-related trials, suggesting a concentration of expertise in this particular immunotherapy approach.

The trials primarily target pediatric patients, though some accept young adults up to age 21. All studies require participants to have specific genetic markers or mutations, emphasizing the move toward personalized medicine in treating blood cancers. Common requirements across trials include adequate organ function, ability to swallow oral medications, and sufficient performance status.

A notable feature is the extended timeline of these studies, with several expected to continue until 2030 or 2031, and one follow-up study monitoring patients for up to 15 years. This long-term approach reflects the serious nature of the condition and the need for comprehensive safety data on these novel treatments.

Ongoing Clinical Trials on Precursor T-lymphoblastic lymphoma/leukaemia recurrent

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