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Ongoing Clinical Trials for Anaplastic Large Cell Lymphoma T- and Null-Cell Types

There are currently 7 clinical trials testing new treatments for anaplastic large cell lymphoma T- and null-cell types. These studies are evaluating different medications including targeted therapies, immunotherapy, and chemotherapy options. The trials are taking place across Europe, with most concentrated in Denmark, France, Germany, Italy, and the Netherlands. Patients can participate in trials testing single medications or combination treatments at various stages of the disease.

Clinical trial locations

Study of Brigatinib for Children and Young Adults with ALK+ Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors, or Other Solid Tumors

This trial is testing brigatinib, a targeted therapy taken as a tablet, in children and young adults with ALK-positive cancers. The study focuses on patients between 1 and 26 years old who can swallow tablets and weigh at least 10 kilograms.

Who can participate: Patients must have confirmed ALK-positive cancer shown through specific tests. For those in Phase 1, the cancer should have returned or not responded to at least one round of standard chemotherapy. Patients need to have reasonable physical functioning, with performance scores of at least 40-50% depending on age and cancer type. They must not be taking other experimental medications or herbal therapies.

What the study excludes: Patients without these specific cancer types, those outside the age range, and those who cannot be classified as male or female cannot join.

Study focus: The trial aims to find the best dose of brigatinib for young patients and understand how the body processes the medication. It will measure how effectively brigatinib shrinks tumors and evaluate treatment responses. For ALK-positive lymphoma patients, treatment may continue for up to two years if they benefit without significant side effects.

Treatment medication: Brigatinib is available in 30 mg, 90 mg, and 180 mg tablets. It works by blocking the ALK protein that helps cancer cells grow and spread.

Study of Crizotinib and Temsirolimus for Children with ALK, ROS1, or MET Positive Cancers, Including Neuroblastoma and Rhabdomyosarcoma

This study examines crizotinib, used alone or combined with temsirolimus, for children with cancers that have specific genetic markers. The trial is for patients between 1 and 21 years old with cancers that have returned or not responded to standard treatments.

Who can participate: Patients must have confirmed diagnoses of neuroblastoma, rhabdomyosarcoma, or anaplastic large cell lymphoma with ALK, ROS1, or MET genetic changes. They need a performance status score above 60%, life expectancy of at least 12 weeks, and measurable disease visible on medical imaging. Previous cancer treatments must have been completed at least 2 weeks before starting this medication, and patients must not have had previous treatments targeting these specific genes.

What the study excludes: Patients with different cancer types, those outside the age range, those unable to follow study procedures, those with medical conditions interfering with treatment, pregnant or breastfeeding patients, those in other trials, recent surgery patients, those allergic to study medications, those with certain heart conditions, uncontrolled infections, or history of substance abuse cannot participate.

Study focus: The trial will determine the best dose of crizotinib combined with temsirolimus and assess safety and effectiveness. Treatment begins with crizotinib as capsules or granules, sometimes combined with intravenous temsirolimus. Regular monitoring includes measuring tumor size and evaluating overall health.

Treatment medications: Crizotinib targets specific proteins in cancer cells to stop their growth and spread. Temsirolimus blocks a protein that helps cancer cells grow. Both are tyrosine kinase inhibitors, a type of targeted cancer therapy.

Study of Nivolumab for Children and Adults with Relapsed or Refractory ALK+ Anaplastic Large Cell Lymphoma

This trial evaluates nivolumab, an immunotherapy medication, for patients whose lymphoma has returned or not responded to previous treatments. The study is divided into two groups: one for patients with active disease and another for those in complete remission after a relapse.

Who can participate: Patients must be older than 6 months with confirmed ALK-positive lymphoma. They need adequate organ function, including healthy levels of blood cells, kidney function, and liver enzymes. Performance status must be at least 40%, and patients must have recovered from previous treatment side effects. For the first group, patients need measurable disease visible on scans and must have had prior chemotherapy and ALK inhibitor treatment. For the second group, patients must have achieved complete response with ongoing treatment and be eligible for stem cell transplant.

What the study excludes: Patients with different cancer types, those whose cancer hasn’t returned or worsened, those outside the specified age range, those unable to follow study procedures, those with serious health conditions, pregnant or breastfeeding patients, those with recent infections, those in other trials, and those allergic to the medication cannot join.

Study focus: The study evaluates nivolumab given through intravenous infusion. For the first group, the focus is on response within 24 weeks. For the second group, nivolumab is used as consolidation therapy. Regular monitoring includes imaging tests and laboratory assessments, with long-term follow-up extending up to 5 years.

Treatment medication: Nivolumab is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells by blocking the PD-1 protein on immune cells.

Study on Vinblastine for Children and Adolescents with Standard Risk ALK-Positive Anaplastic Large Cell Lymphoma

This clinical trial tests whether vinblastine sulfate alone can effectively treat children and adolescents newly diagnosed with standard risk ALK-positive lymphoma for 24 months.

Who can participate: Patients must be younger than 18 years old with ALK-positive lymphoma classified as standard risk (Stage I not completely surgically removed, or Stage II or III with no minimal disease detected). Parents or guardians must provide informed consent, and patients must be able to be followed for at least 3 years. Sexually active participants must use highly effective birth control. Before starting the main treatment, patients receive one dose of intrathecal triple therapy with methotrexate, cytarabine, and prednisolone directly into the spinal fluid.

What the study excludes: Patients without ALK-positive lymphoma, those not at standard risk, those outside the age range, and those unable to follow the 24-month treatment plan cannot participate.

Study focus: After initial screening and consent, patients receive a pre-treatment procedure involving three medications delivered into the spinal fluid. The main treatment involves vinblastine sulfate given through a vein for 24 months, followed by at least 3 years of follow-up monitoring.

Treatment medication: Vinblastine sulfate is a chemotherapy drug given by injection that interferes with cancer cell growth. It’s a vinca alkaloid that works by preventing cancer cells from dividing and multiplying.

Study of dapagliflozin to prevent heart complications during lymphoma treatment in patients receiving first-line therapy

This study examines whether dapagliflozin can protect the heart from damage during standard lymphoma treatment. The medication is typically used for diabetes but is being tested for cardioprotective effects during cancer therapy.

Who can participate: Patients must be 18 to 80 years old, diagnosed with diffuse large B-cell lymphoma, follicular lymphoma, or T-cell lymphoma not requiring immediate stem cell transplant, and planning to receive 6 cycles of standard chemotherapy. They must have heart function with ejection fraction of 50% or higher, be able to read Danish, provide written consent, use effective birth control, and attend all study visits.

What the study excludes: Patients under 18 or over 75 years old, those with type 1 diabetes, history of diabetic ketoacidosis, severe kidney disease, pregnancy or breastfeeding, allergies to SGLT2 inhibitors, active infections, severe heart problems, frequent urinary infections, poor compliance history, or low blood pressure cannot join.

Study focus: Patients are randomly assigned to receive either dapagliflozin or placebo tablets taken orally once daily for 6 months while receiving standard lymphoma treatment. Heart function is monitored through regular tests including heart scans, blood tests, and electrocardiograms. The study measures heart muscle strain and other cardiac indicators throughout treatment and during follow-up.

Treatment medications: Dapagliflozin is an SGLT2 inhibitor that helps kidneys remove sugar through urine and may protect heart cells during chemotherapy. Standard lymphoma treatment includes R-CHOP or R-CHOEP chemotherapy combinations, which are effective against cancer but can potentially affect heart function.

Study of Lorlatinib for Patients with ALK+ Anaplastic Large Cell Lymphoma After Ineffective ALK Inhibitor Treatment

This trial studies lorlatinib for patients whose ALK-positive lymphoma has returned or not responded to previous ALK inhibitor treatments.

Who can participate: Patients must be at least 18 years old with confirmed ALK-positive lymphoma by specific tests. The disease must be refractory or relapsed after at least one chemotherapy regimen and one ALK inhibitor, with measurable disease visible on examination or scans. Previous treatments must have been completed at least 14 days before starting the study. Patients must be able to take oral medication, have performance status between 0 and 3, and have adequate organ and bone marrow function. Those able to have children must use two effective forms of contraception during the study and for 90 days after.

What the study excludes: Patients with different cancer types, those whose cancer responded to ALK inhibitors, those under 18 years old, and vulnerable populations cannot participate.

Study focus: Lorlatinib is taken as oral tablets. The study monitors response through regular visits including physical examinations, blood tests, and imaging studies. The primary goal is determining objective response rates, with secondary evaluations including progression-free survival, overall survival, side effects, and quality of life.

Treatment medication: Lorlatinib is a tyrosine kinase inhibitor that targets and blocks the ALK protein activity, helping to slow or stop cancer cell growth.

Study of Romidepsin and Drug Combination for Young Patients with Peripheral T-Cell Lymphomas Before Stem Cell Transplantation

This trial tests a combination of romidepsin and CHOEP chemotherapy as first-line treatment before stem cell transplantation for specific types of peripheral T-cell lymphomas.

Who can participate: Patients must be between 18 and 65 years old with diagnosed peripheral T-cell lymphoma (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), or ALK-negative anaplastic large cell lymphoma (ALCL). They need cancer stage between II and IV, no previous lymphoma treatment, and no brain or spinal cord involvement. Patients must have adequate organ function including heart ejection fraction greater than 50%, kidney clearance greater than 60 ml/min, and lung function with DLCO greater than 50%. They must be HIV negative, have no active hepatitis C, and be negative for hepatitis B or receiving preventive treatment. Tissue samples must be available for review.

What the study excludes: Patients with ALK-negative anaplastic large T-cell lymphoma, angioimmunoblastic T-cell lymphoma, or peripheral T-cell lymphoma NOS as the exclusion criteria appear to contradict the inclusion criteria in the source data.

Study focus: Phase I determines the maximum tolerated dose of romidepsin combined with CHOEP chemotherapy. Phase II evaluates effectiveness in preventing disease progression. Treatment involves romidepsin given intravenously combined with CHOEP chemotherapy. Regular monitoring tracks health and side effects throughout the trial, with final assessment at the end.

Treatment medications: Romidepsin is a histone deacetylase inhibitor given intravenously that interferes with cancer cell growth by affecting gene expression. CHOEP is a chemotherapy combination including cyclophosphamide, doxorubicin, vincristine, etoposide, and prednisone, each working differently to stop cancer cell growth.

Summary

The 7 ongoing clinical trials for anaplastic large cell lymphoma T- and null-cell types show a strong focus on targeted therapies, particularly ALK inhibitors. Denmark appears most frequently as a trial location, hosting 5 of the 7 studies, followed by France, Germany, Italy, and the Netherlands. Several trials specifically target pediatric and young adult populations, with age ranges typically starting from 1 year old up to 26 years.

A notable pattern is the concentration on ALK-positive lymphoma subtypes, with medications like brigatinib, crizotinib, lorlatinib, and nivolumab being tested at various disease stages. Three trials focus on newly diagnosed standard-risk patients, while others target relapsed or refractory disease. The studies employ different treatment strategies: some test single agents, others combine targeted therapies with chemotherapy, and one investigates cardioprotective measures during standard treatment.

Treatment durations vary significantly, from 6-month interventions to 24-month protocols, with follow-up periods extending up to 5 years. Most trials require specific genetic testing to confirm ALK-positive status and exclude patients with certain organ function limitations or those who cannot follow study procedures.

Ongoing Clinical Trials on Anaplastic large cell lymphoma T- and null-cell types

  • Study of Nivolumab for Children and Adults with Relapsed or Refractory ALK+ Anaplastic Large Cell Lymphoma

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark France

  • Study of Crizotinib and Temsirolimus for Children with ALK, ROS1, or MET Positive Cancers, Including Neuroblastoma and Rhabdomyosarcoma

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark Finland France Germany Italy The Netherlands +3

  • Study on Vinblastine for Children and Adolescents with Standard Risk ALK-Positive Anaplastic Large Cell Lymphoma

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Denmark Finland France Germany +2

  • Study of Lorlatinib for Patients with ALK+ Anaplastic Large Cell Lymphoma After Ineffective ALK Inhibitor Treatment

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study of Romidepsin and Drug Combination for Young Patients with Peripheral T-Cell Lymphomas Before Stem Cell Transplantation

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Italy

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