Ongoing Clinical Trials for T-cell Lymphoma
Currently, there are 6 clinical trials investigating new treatments for T-cell lymphoma across Europe. These trials are testing various approaches, including CAR T-cell therapy, antibody treatments, and novel drug combinations to help patients with different forms of this blood cancer.
Clinical trial locations
- Denmark
- France
- Study of Mogamulizumab and Total Skin Electron Beam Therapy for Patients with Stage IB-IIB Cutaneous T-Cell Lymphoma
- Study on the Safety and Effectiveness of LIS1 for Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma (PTCL)
- Study of Tolinapant with Decitabine and Cedazuridine for Patients with Relapsed or Refractory Peripheral T-cell Lymphoma
- Germany
- Greece
- Hungary
- Italy
- Study of CD7-CART01, Cyclophosphamide, and Fludarabine Phosphate for Children and Young Adults with Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia/Lymphoma
- Study of Mogamulizumab and Total Skin Electron Beam Therapy for Patients with Stage IB-IIB Cutaneous T-Cell Lymphoma
- Study on the Safety and Effectiveness of LIS1 for Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma (PTCL)
- Study of Tolinapant with Decitabine and Cedazuridine for Patients with Relapsed or Refractory Peripheral T-cell Lymphoma
- Poland
- Spain
- Study of Mogamulizumab and Total Skin Electron Beam Therapy for Patients with Stage IB-IIB Cutaneous T-Cell Lymphoma
- Study of Fadraciclib in Adults with Advanced Solid Tumors (Including Breast, Colorectal, Endometrial, Ovarian, Biliary Tract, and Liver Cancer) and Lymphoma
- Study of Tolinapant with Decitabine and Cedazuridine for Patients with Relapsed or Refractory Peripheral T-cell Lymphoma
Study of CD7-CART01, Cyclophosphamide, and Fludarabine Phosphate for Children and Young Adults with Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia/Lymphoma
This trial is testing a specialized treatment called CD7-CART01 for children and young adults with T-cell acute lymphoblastic leukemia or lymphoma that has returned or not responded to previous treatments. The study focuses on patients aged 6 months to 25 years.
Main inclusion criteria: Participants must have CD7-expressing cancer (more than 98% of cancer cells showing the CD7 marker), be between 6 months and 25 years old, and have adequate blood vessel access for a procedure called apheresis. The cancer must be measurable using tests, and there should be a potential stem cell donor available. Participants must have a performance status of at least 60% on the appropriate scale.
Main exclusion criteria: Patients with unrelated cancers, active infections that could worsen with treatment, severe allergic reactions to similar treatments, pregnancy or breastfeeding, and those unable to follow study procedures are excluded. Patients who have received certain recent treatments that might interfere with the study are also not eligible.
Focus and goal: The trial aims to evaluate the safety of CD7-CART01 and find the best dose to use. It is divided into two phases: the first focuses on safety and dose-finding, while the second examines how well the treatment works at the chosen dose. The treatment involves collecting T cells from the patient’s blood, modifying them to target CD7, and then infusing them back after conditioning therapy with cyclophosphamide and fludarabine phosphate.
Investigational drug: CD7-CART01 uses genetically modified T cells that express a chimeric antigen receptor targeting the CD7 protein on cancer cells. This CAR T-cell therapy is designed to specifically recognize and destroy cancer cells carrying the CD7 marker.
Study of Mogamulizumab and Total Skin Electron Beam Therapy for Patients with Stage IB-IIB Cutaneous T-Cell Lymphoma
This international trial is testing a combination treatment for cutaneous T-cell lymphoma, which primarily affects the skin. The study focuses on two subtypes: Mycosis Fungoides and Sézary Syndrome at stages IB to IIB.
Main inclusion criteria: Participants must be 18 years or older with confirmed Mycosis Fungoides at stages IB, IIA, or IIB. They must have tried at least one previous systemic treatment (excluding PUVA therapy). Participants need adequate blood cell counts and organ function, and must provide informed consent. Women of childbearing age must use adequate contraception.
Main exclusion criteria: Patients with other types of cancer, uncontrolled serious infections, history of severe allergies to similar treatments, pregnancy or breastfeeding, recent participation in other trials, unstable heart conditions, severe liver or kidney problems, and those unable to follow study procedures are excluded.
Focus and goal: The study evaluates combining mogamulizumab with Total Skin Electron Beam therapy. The primary goal is to assess progression-free survival at 48 weeks. Secondary outcomes include overall safety, response rates, overall survival, time to disease progression, and quality of life. Regular monitoring helps track both treatment effectiveness and any side effects.
Investigational drugs: Mogamulizumab is a monoclonal antibody that targets the CCR4 protein on cancer cells, administered through intravenous infusion. Total Skin Electron Beam therapy uses specialized radiation to treat the entire skin surface, targeting cancer cells while minimizing damage to deeper tissues.
Study on the Safety and Effectiveness of LIS1 for Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma (PTCL)
This trial studies LIS1, a glyco-humanized polyclonal antibody, for treating peripheral T-cell lymphoma that has returned or not responded to previous treatments. The study is conducted in France and Italy.
Main inclusion criteria: Participants must be 18 years or older with an ECOG performance status of 0 or 1, indicating they can perform daily activities. They need a life expectancy exceeding 3 months and adequate organ and blood function. Participants must have confirmed PTCL, received at least one previous appropriate treatment, experienced disease progression, and have measurable tumors. Tissue samples and bone marrow aspirate must be available for review.
Main exclusion criteria: Patients with cancer types other than PTCL, those outside the specified age range, vulnerable populations requiring special protection, and those not meeting specific health and safety requirements are excluded from participation.
Focus and goal: The study has two parts: dose escalation to find the safest maximum tolerated dose, and dose expansion to evaluate treatment effectiveness. LIS1 is given through intravenous infusion in 28-day cycles. The trial aims to determine if LIS1 can effectively reduce tumor size or slow disease progression while monitoring safety and side effects.
Investigational drug: LIS1 is a glyco-humanized polyclonal antibody designed to target and attack tumoral T cells. It is administered as a concentrate for solution for infusion directly into the bloodstream.
Study of dapagliflozin to prevent heart complications during lymphoma treatment in patients receiving first-line therapy
This Danish study investigates whether dapagliflozin can protect the heart from potential damage during standard cancer treatment for various types of lymphoma, including diffuse large B-cell lymphoma, follicular lymphoma, and T-cell lymphomas.
Main inclusion criteria: Participants must be 18 to 80 years old with diagnosed lymphoma planning to receive 6 cycles of standard chemotherapy. They must have a heart ejection fraction of at least 50%, be able to read and understand Danish, and use effective birth control methods. Participants need to be able to attend all study visits and follow instructions.
Main exclusion criteria: Excluded are those under 18 or over 75 years old, people 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 tract infections, medication interactions, inability to provide consent, recent participation in other trials, poor compliance history, and low blood pressure.
Focus and goal: The study examines whether taking dapagliflozin alongside standard lymphoma treatment can prevent heart-related side effects. Participants receive either dapagliflozin or placebo tablets for 6 months while undergoing cancer treatment. Doctors monitor heart function using various tests, including examining heart muscle movement and blood markers indicating heart health.
Investigational drugs: Dapagliflozin is an SGLT2 inhibitor taken once daily by mouth. While typically used for diabetes, this study investigates its potential cardioprotective effects. Standard treatment includes R-CHOP or R-CHOEP chemotherapy combinations given intravenously.
Study of Fadraciclib in Adults with Advanced Solid Tumors (Including Breast, Colorectal, Endometrial, Ovarian, Biliary Tract, and Liver Cancer) and Lymphoma
This Spanish trial studies fadraciclib in people with various advanced cancers, including B-cell lymphoma and T-cell lymphoma, along with several types of solid tumors. The medication is taken by mouth in tablet form.
Main inclusion criteria: Participants must be 18 years or older with confirmed advanced cancer that has progressed despite standard treatment, or for which no standard treatment exists. They need an ECOG performance status of 0 or 1, meaning they can carry out normal activities with minimal restrictions. Laboratory tests must meet specific requirements. Women of childbearing potential need negative pregnancy tests and must use effective birth control, as must men who can father children. Participants must be able to swallow medications and follow study requirements.
Main exclusion criteria: Excluded are those who received CDK inhibitors within 14 days before the study, have active brain metastases or spinal cord compression, had major surgery within 4 weeks, have serious heart conditions, uncontrolled infections, known HIV or active hepatitis, other active cancers requiring treatment, pregnancy or breastfeeding, serious medical conditions interfering with participation, inability to swallow oral medications, or known allergies to study components.
Focus and goal: The study aims to find the best dose of fadraciclib and determine how well it works in treating different cancer types. Participants take the medication once or twice daily in 28-day cycles, continuing as long as it helps and side effects remain manageable. Regular monitoring tracks health status and cancer response to treatment.
Investigational drug: Fadraciclib (CYC065) is a CDK2/9 inhibitor that blocks proteins helping cancer cells grow. It is an oral medication designed for patients whose cancer has returned or not responded to standard therapies.
Study of Tolinapant with Decitabine and Cedazuridine for Patients with Relapsed or Refractory Peripheral T-cell Lymphoma
This multi-country trial tests a new treatment combination for peripheral T-cell lymphoma that has returned or not responded to previous treatments. The study includes participants from Spain, France, Italy, Poland, and Hungary.
Main inclusion criteria: Participants must be 18 years or older with a life expectancy exceeding 12 weeks and confirmed relapsed or refractory PTCL. They must have evidence of disease progression, received at least two previous treatments, and have measurable disease on CT scan. If the disease is CD30-positive, participants must have received, be ineligible for, or unable to tolerate brentuximab vedotin. An ECOG performance status of 0, 1, or 2 is required, along with acceptable organ function. Women of childbearing potential must have negative pregnancy tests and use effective birth control.
Main exclusion criteria: Excluded are those without relapsed or refractory PTCL, those outside the specified age range, those unable to follow study procedures or take medications as required, those with serious health conditions interfering with the study, pregnant or breastfeeding women, recent participants in other trials, those with allergies to study medications, and those unable to provide informed consent.
Focus and goal: The trial has two phases: determining the safest dose of tolinapant combined with decitabine/cedazuridine, and evaluating treatment effectiveness. Participants receive either the combination therapy or decitabine/cedazuridine alone, with some receiving placebo for comparison. All medications are taken orally, and regular monitoring assesses health and any side effects.
Investigational drugs: Tolinapant is an inhibitor of apoptosis proteins being studied in combination with decitabine/cedazuridine. Decitabine helps stop cancer cells from growing, while cedazuridine prevents decitabine from breaking down too quickly in the body, improving its effectiveness.
Summary
The 6 ongoing clinical trials for T-cell lymphoma represent diverse approaches to treating this challenging disease. Italy appears most frequently as a trial location, hosting 4 studies, followed by France and Spain with 3 each. Several trials focus specifically on relapsed or refractory disease, reflecting the need for better treatment options when standard therapies fail.
Treatment approaches vary considerably. Some trials investigate innovative immunotherapies like CD7-CART01 and LIS1, while others test combination strategies using antibodies like mogamulizumab with radiation therapy. Novel drug combinations such as tolinapant with decitabine/cedazuridine offer alternative mechanisms for attacking cancer cells. Notably, one trial takes a unique cardioprotective approach, studying whether dapagliflozin can prevent heart damage during standard chemotherapy.
Most trials focus on adults, though one specifically targets children and young adults aged 6 months to 25 years. The studies examine various subtypes including cutaneous T-cell lymphoma, peripheral T-cell lymphoma, and T-cell acute lymphoblastic leukemia/lymphoma, reflecting the disease’s heterogeneous nature.
These trials represent important steps toward improving outcomes for patients with T-cell lymphoma, particularly those whose disease has not responded to existing treatments or has returned after initial therapy.
