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Precursor B-lymphoblastic lymphoma refractory – Trials in Disease

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Ongoing Clinical Trials for Precursor B-lymphoblastic Lymphoma Refractory

There are currently 3 clinical trials investigating new treatment options for children with precursor B-lymphoblastic lymphoma that has not responded to standard treatment. These studies are testing combinations of targeted therapies designed to work against specific genetic changes in cancer cells, and are being conducted across multiple European countries.

Clinical trial locations

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

This study is testing two medications, Venetoclax (also known as ABT-199) and Dasatinib, in children whose disease has returned or not responded to previous treatment. Both medications are given by mouth as tablets or liquid and are designed to stop cancer cells from growing by targeting specific genetic changes in the cells.

Who can join: Children aged 1 to 18 years at first diagnosis and under 21 years when joining the study can participate. They must be able to swallow tablets and have a certain level of daily activity, measured by performance scores. Before joining, patients must have had advanced testing showing specific genetic changes in their cancer cells, particularly in pathways called MAPK or SRC. Examples include changes in genes like NUP214-ABL1, ABL1, or PDGFRβ. The child’s organs, especially kidneys, liver, and heart, must be working well enough to safely receive the medications.

Who cannot join: Children 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, and those who have received another experimental treatment within the last 4 weeks cannot participate. Children who cannot follow study procedures due to any reason are also excluded.

Main goal: The study has two phases. The first phase determines the safest dose of the medications. The second phase evaluates how well the medications work in treating the cancer. Researchers will track whether the cancer responds to treatment, how long before it might return, and the quality of life of participants using a special questionnaire for children with cancer.

Investigational drugs: Venetoclax and Dasatinib are both anti-cancer medications that work by interfering with processes cancer cells need to survive and multiply. They specifically target genetic changes in the MAPK/SRC signaling pathway.

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

This trial is investigating two medications, Venetoclax (ABT-199) and Ruxolitinib (INCB018424), for children whose blood cancer has returned or not responded to treatment. The medications target specific genetic changes in a cell communication system called the IL-7R/JAK-STAT pathway, which can affect cancer growth. Both medications are taken by mouth as tablets or liquid.

Who can join: Children between 1 and 18 years old at first diagnosis and under 21 years when joining can participate. They must be able to swallow tablets and have adequate energy levels for daily activities. Before joining, patients must have undergone detailed testing showing specific genetic changes such as alterations in genes like CRLF2, EPOR, JAK1/2/3, IL-7R, or STAT5B. The child’s kidneys, liver, and heart must be functioning properly to safely tolerate the treatment.

Who cannot join: Children with different types of cancer, those outside the specified age range, those unable to follow study procedures, pregnant or breastfeeding patients, those with serious health conditions that might interfere, those who had recent major surgery, those currently in another trial, those allergic to study drugs, those with certain heart problems, and those with active infections requiring treatment cannot participate.

Main goal: The study is divided into two phases. Phase one focuses on finding the safest dose that can be given to patients. Phase two evaluates how effective the medications are in treating cancers with specific genetic changes in the IL-7R/JAK-STAT pathway. Throughout the study, participants are closely monitored for safety and response to treatment.

Investigational drugs: Venetoclax and Ruxolitinib are targeted therapies designed to work against cancer cells with specific genetic changes. They aim to stop cancer cell growth by interfering with molecular pathways essential for cancer cell survival.

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

This clinical trial tests a combination of four medications: Trametinib, Dexamethasone, Cyclophosphamide, and Cytarabine in children whose blood cancer has returned or not responded to treatment. The study aims to determine both the safety and effectiveness of this combination therapy.

Who can join: Children aged 1 to 18 years at first diagnosis and under 21 years when joining can participate. They must be able to swallow tablets. Children under 6 years must weigh at least 26 kg, and those over 6 years must weigh at least 33 kg. Participants must have adequate energy for daily activities. Before joining, patients must have undergone molecular testing showing specific genetic changes called RAS pathway activating mutations, which include changes in genes like KRAS, NRAS, HRAS, FLT3, or PTPN11. The child’s kidneys, liver, and heart must be working well enough to safely receive the treatments.

Who cannot join: Children with different types of cancer, those outside the age range, those unable to follow study procedures, those with other serious health conditions, pregnant or breastfeeding patients, those recovering from recent major surgery, those currently in another trial, those with allergies to study drugs, those with certain heart problems, and those with active infections requiring treatment cannot participate.

Main goal: The trial has two phases. The first phase determines the maximum safe dose of the medications that can be given while monitoring for side effects. The second phase evaluates the effectiveness of the treatment at the doses determined in phase one. Medications are given in various forms including oral tablets, injections into the spinal fluid, and intravenous infusions. Throughout the study, patients are closely monitored with regular blood tests, imaging studies, and other evaluations to assess response and manage any side effects.

Investigational drugs: This combination includes Trametinib (oral tablets), Dexamethasone (oral and intravenous forms), Cyclophosphamide (intravenous), and Cytarabine (intravenous). These medications work by targeting specific genetic changes in cancer cells and interfering with pathways that cancer cells need to survive and grow.

Summary

All three clinical trials focus on children with blood cancers that have either returned after treatment or have not responded to standard therapies. A notable feature is that each trial targets specific genetic changes in the cancer cells, representing a shift toward personalized medicine based on the molecular characteristics of each patient’s disease.

The trials are widely distributed across Europe, with all three studies available in countries including Italy, Germany, Sweden, Finland, Spain, Norway, Denmark, Netherlands, and Austria. Some trials are also available in Belgium and France. This broad geographic distribution increases access for families across the continent.

Common to all studies is Venetoclax, which appears in two of the three trials combined with different partner medications (Dasatinib or Ruxolitinib). Each trial requires patients to have undergone advanced molecular testing before joining to identify the specific genetic changes that make them suitable candidates for the particular medications being studied.

All trials are long-term studies expected to continue until 2030 or 2031, with recruitment starting in 2024. Each study follows a two-phase approach: first determining the safest dose, then evaluating how well the treatment works. This structured approach helps ensure patient safety while gathering important information about treatment effectiveness.

Ongoing Clinical Trials on Precursor B-lymphoblastic lymphoma refractory

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