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Ongoing Clinical Trials for Precursor T-lymphoblastic Lymphoma/Leukaemia Refractory

There are currently 3 ongoing clinical trials investigating new treatment options for children with precursor T-lymphoblastic lymphoma/leukaemia that has not responded to standard treatment or has returned after treatment. These trials are being conducted across multiple European countries and are testing combinations of targeted medications designed to work against specific genetic changes in cancer cells.

Clinical trial locations

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

This trial is testing two medications, Venetoclax and Dasatinib, in children whose blood cancer has either returned after treatment or has not responded to standard therapies. Both medications are taken by mouth and work by targeting cancer cells in different ways to stop their growth.

Who can join this trial:

  • Children aged 1 to 18 years at first diagnosis, and under 21 years when joining the study
  • Able to swallow tablets (or use liquid forms if available)
  • Have a reasonable level of daily activity, measured by performance scores
  • Must have had advanced testing of their cancer cells that shows specific genetic changes in the MAPK/SRC pathway
  • Kidneys, liver, and heart must be working well enough based on blood tests and heart scans

Who cannot join this trial:

  • Children with other types of cancer not being studied
  • Those who have had severe allergic reactions to similar treatments
  • Pregnant or breastfeeding patients
  • Those with severe heart problems or uncontrolled infections
  • Patients who received another experimental treatment within the last 4 weeks
  • Those with drug or alcohol abuse issues that could interfere with the study

What the trial aims to do: The main goal is to find the safest dose of these medications and to see how well they work in stopping cancer growth in children with specific genetic changes in their cancer cells. The study will track how patients respond to treatment, how long it takes for the cancer to return (if it does), and the quality of life of the children during treatment.

Investigational drugs: The trial uses Venetoclax (also called ABT-199) and Dasatinib, both classified as anti-cancer medications that target specific proteins in cancer cells to prevent their growth and spread.

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

This clinical trial examines the combination of Ruxolitinib and Venetoclax in children whose blood cancer has either come back or not responded to previous treatments. The study focuses on patients with specific genetic changes in the IL-7R/JAK-STAT pathway, which is involved in cell growth and can contribute to cancer development.

Who can join this trial:

  • Children between 1 and 18 years old at initial diagnosis, and under 21 when joining the study
  • Must be able to swallow tablets
  • Have adequate energy levels for daily activities based on performance scores
  • Must have had molecular testing showing specific genetic changes in the IL-7R/JAK-STAT pathway
  • Kidneys, liver, and heart must function properly according to blood tests and heart evaluations

Who cannot join this trial:

  • Children with different cancer types not included in the study
  • Those outside the specified age range
  • Unable to follow study procedures
  • Those with other serious health conditions that could interfere
  • Pregnant or breastfeeding patients
  • Those allergic to the study drugs
  • Patients with poorly controlled infections or certain heart problems

What the trial aims to do: The study will determine the safest dose that can be given to patients and evaluate how effectively the medications work against the cancer. It will measure response rates, track any side effects, and monitor patients’ overall health throughout treatment.

Investigational drugs: The trial tests Ruxolitinib (also known as INCB018424) and Venetoclax (ABT-199), both taken orally. These medications are designed to target specific molecular pathways that cancer cells use to survive and multiply.

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

This trial investigates a combination of four medications—Trametinib, Dexamethasone, Cyclophosphamide, and Cytarabine—for children whose blood cancer has returned or has not responded to standard treatment. The medications are given in different forms, including tablets and injections.

Who can join this trial:

  • Children aged 1 to 18 years at first diagnosis, and under 21 when entering the study
  • Must be able to swallow tablets
  • Minimum weight requirements: at least 26 kg for children under 6 years, and 33 kg for those over 6 years
  • Must have performance scores showing reasonable activity levels
  • Must have specific genetic changes in the RAS pathway, identified through molecular testing
  • Adequate kidney, liver, and heart function based on laboratory tests and heart scans

Who cannot join this trial:

  • Children with cancer types not included in the study
  • Those outside the specified age range
  • Unable to follow study procedures
  • Those with other serious medical conditions
  • Pregnant or breastfeeding patients
  • Recent major surgery patients
  • Those currently in another clinical trial
  • Patients allergic to the study medications
  • Those with heart problems or active infections requiring treatment

What the trial aims to do: The study has two phases. The first phase determines the safest dose of the medication combination. The second phase evaluates how well the treatment works in children with specific genetic changes in their cancer cells. Throughout the study, patients are closely monitored for safety and effectiveness.

Investigational drugs: The trial uses a combination of targeted therapies and chemotherapy drugs. Trametinib targets specific molecular pathways in cancer cells, while Dexamethasone, Cyclophosphamide, and Cytarabine work through different mechanisms to stop cancer cell growth.

Summary

All three ongoing clinical trials share a similar approach: they target children with blood cancers that have proven difficult to treat with standard therapies. Each trial focuses on specific genetic changes within the cancer cells, using this information to select medications that are most likely to be effective for each patient.

The trials are widely distributed across Europe, with all three studies being conducted in Austria, Denmark, Finland, Germany, Italy, Netherlands, Norway, Spain, and Sweden. This broad geographic coverage increases access to these experimental treatments for families across multiple countries.

A notable feature of these studies is their use of targeted therapy—medications designed to attack cancer cells based on their specific genetic characteristics rather than using a one-size-fits-all approach. Venetoclax appears in two of the three trials, suggesting it is an important medication being tested for these conditions.

All trials are expected to continue until at least 2030 or 2031, reflecting the long-term commitment needed to fully understand the safety and effectiveness of these treatments. The studies are divided into phases, with initial phases focusing on finding safe doses and later phases evaluating how well the treatments actually work.

These trials represent hope for families dealing with blood cancers that have not responded to conventional treatment, offering access to cutting-edge therapies that may not otherwise be available.

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

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