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Precursor B-lymphoblastic lymphoma recurrent – Trials in Disease

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Ongoing Clinical Trials for Precursor B-lymphoblastic Lymphoma Recurrent

There are currently 3 clinical trials investigating new treatment options for children and young adults with precursor B-lymphoblastic lymphoma that has returned after treatment. These studies are being conducted across multiple European countries and focus on testing combinations of targeted medications that 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, for children whose blood cancer has returned after treatment or has not responded to previous therapies. Both medications are designed to target specific changes in cancer cells related to the MAPK/SRC signaling pathway, which is involved in cancer cell growth.

Main inclusion criteria: Children between 1 and 18 years old at first diagnosis and under 21 years when joining the study are eligible. They must be able to swallow tablets and have a performance score of at least 50%, which measures their ability to carry out daily activities. The child’s cancer must show specific genetic changes identified through advanced molecular testing. Adequate organ function is required, including proper kidney, liver, and heart function, measured through various blood tests and heart scans.

Main exclusion criteria: Children with other types of cancer not being studied, those with severe allergic reactions to similar treatments, pregnant or breastfeeding patients, those with severe heart problems or uncontrolled infections, and those who received another experimental treatment within the last four weeks cannot participate. Children who cannot follow study procedures are also excluded.

Focus and goal: The study is divided into two phases. The first phase aims to find the safest dose of the medications, while the second phase evaluates how well they work in treating the cancer. Researchers will track various outcomes, including overall response to treatment and the time it takes for cancer to return. The trial will also assess quality of life using a questionnaire designed for children with cancer.

Investigational drugs: The trial tests Venetoclax, available as oral suspension and tablets, and Dasatinib, available as tablets and powder for oral suspension. Both are anti-neoplastic agents that work to stop cancer cell growth by targeting specific molecular pathways in cancer cells.

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 Venetoclax and Ruxolitinib for children whose blood cancer has returned or hasn’t responded to treatment. The medications target specific genetic changes in the IL-7R/JAK-STAT signaling pathway, which affects how cancer cells communicate and grow.

Main inclusion criteria: Eligible children must be between 1 and 18 years old at diagnosis and under 21 when joining. They must be able to swallow tablets and have a Karnofsky or Lansky performance score of at least 50%. The patient’s tumor must show specific changes in pathways like IL-7R and JAK-STAT, including rearrangements or mutations in genes such as CRLF2, EPOR, JAK1/2/3, and others. Adequate kidney, liver, and heart function is required, with specific limits on blood test results and heart function measurements.

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

Focus and goal: The trial has two phases: the first determines the safest dose of the medications while monitoring for side effects, and the second evaluates treatment effectiveness at the determined doses. Regular monitoring throughout the trial assesses response to treatment and any side effects through blood tests, imaging studies, and other evaluations.

Investigational drugs: Both Venetoclax and Ruxolitinib are administered orally as tablets or suspensions. These investigational agents are designed to target specific genetic alterations in cancer cells, aiming to provide more precise treatment options for children with these challenging conditions.

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. The study focuses on children with blood cancer that has returned after treatment or is resistant to previous therapies, particularly when there are specific genetic changes in cancer cells.

Main inclusion criteria: Children aged 1 to 18 years at first diagnosis and under 21 when joining must be able to swallow tablets. Children under 6 years must weigh at least 26 kg, while those over 6 must weigh at least 33 kg. A performance score of at least 50% is required. Written permission from parents or legal representatives and the patient must be obtained. Patients must have specific RAS pathway activating mutations in their tumor, including changes in genes like KRAS, NRAS, HRAS, FLT3, and others. Adequate kidney, liver, and heart function is required, with specific limits on test results.

Main exclusion criteria: Patients with different cancer types, those outside the age range, those unable to follow study procedures, those with serious interfering health conditions, pregnant or breastfeeding patients, those recovering from recent major surgery, those currently in another trial, patients allergic to study drugs, those with certain heart problems, and those with active infections requiring treatment cannot participate.

Focus and goal: The trial is divided into two phases. Phase I focuses on determining the maximum tolerated dose by administering drugs in increasing doses while monitoring side effects. Phase II evaluates treatment effectiveness at the doses determined in Phase I. Throughout the trial, regular monitoring assesses response to treatment and any complications. At the conclusion, a final assessment evaluates overall outcomes and any long-term effects.

Investigational drugs: The trial uses Dexamethasone (oral tablets), Methotrexate (injected into spinal fluid), Dexamethasone sodium phosphate (intravenous), Cyclophosphamide (intravenous infusion), Cytarabine (intravenous infusion), Hydrocortisone (injected into spinal fluid), Prednisolone sodium succinate (injected into spinal fluid), and Trametinib (oral tablets). These targeted cancer therapies aim to interfere with molecular pathways crucial for cancer cell survival and growth.

Summary

All three clinical trials focus on children and young adults with blood cancers that have returned after treatment or haven’t responded to standard therapies. A notable feature is that all studies require patients to have specific genetic changes in their cancer cells, reflecting a move toward personalized medicine based on molecular profiling.

The trials are widely distributed across Europe, with all three studies active in Italy, Germany, Sweden, Finland, Spain, Norway, Denmark, Netherlands, and Austria. This broad geographical coverage suggests strong European collaboration in pediatric cancer research. Belgium and France participate in two of the three trials.

Venetoclax appears in two of the three trials, combined with different partner medications depending on the specific genetic pathway being targeted. All studies follow a two-phase approach: first determining the safest dose, then evaluating treatment effectiveness. The trials are expected to run through 2030 or 2031, with recruitment beginning in 2024, indicating long-term commitment to understanding these treatment approaches.

These studies represent important research efforts to find better treatments for children whose cancers are difficult to treat with standard therapies, focusing on targeting the specific molecular changes that drive their cancer’s growth.

Ongoing Clinical Trials on Precursor B-lymphoblastic lymphoma recurrent

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