Ongoing Clinical Trials for Peripheral T-cell Lymphoma Unspecified
There are currently 6 ongoing clinical trials investigating new treatments for peripheral T-cell lymphoma unspecified. These studies are taking place across multiple European countries and are testing various drug combinations, including novel targeted therapies and chemotherapy regimens, aimed at improving outcomes for patients with this rare and aggressive form of non-Hodgkin lymphoma.
Clinical trial locations
- Belgium
- France
- Study of Lacutamab, Gemcitabine, and Oxaliplatin for Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma
- Study on the Benefits of Autologous Stem Cell Transplantation for Patients with Peripheral T-cell Lymphoma Using Etoposide and Drug Combination
- Study on Brentuximab Vedotin and Drug Combination for Patients with Peripheral T-cell Lymphoma with Less Than 10% CD30 Expression
- Germany
- Hungary
- Italy
- Study on the Effectiveness and Safety of Belinostat and Pralatrexate with Drug Combination for Newly Diagnosed Peripheral T-Cell Lymphoma Patients
- Study of Romidepsin and Drug Combination for Young Patients with Peripheral T-Cell Lymphomas Before Stem Cell Transplantation
- Study on Brentuximab Vedotin and Drug Combination for Patients with Peripheral T-cell Lymphoma with Less Than 10% CD30 Expression
- Study on the Safety and Effects of Tolinapant in Patients with Advanced Solid Tumors and Lymphomas
- Poland
- Spain
- Study of Lacutamab, Gemcitabine, and Oxaliplatin for Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma
- Study on the Effectiveness and Safety of Belinostat and Pralatrexate with Drug Combination for Newly Diagnosed Peripheral T-Cell Lymphoma Patients
- Study on Brentuximab Vedotin and Drug Combination for Patients with Peripheral T-cell Lymphoma with Less Than 10% CD30 Expression
- Study on the Safety and Effects of Tolinapant in Patients with Advanced Solid Tumors and Lymphomas
Study of Lacutamab, Gemcitabine, and Oxaliplatin for Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma
This trial is evaluating a new treatment approach for patients whose disease has returned or has not responded to previous treatments. The study combines a monoclonal antibody called Lacutamab with two chemotherapy drugs, Gemcitabine and Oxaliplatin, known together as GemOx.
Main inclusion criteria: Patients must have confirmed peripheral T-cell lymphoma that has relapsed or is refractory to treatment. The cancer cells must show a specific marker called KIR3DL2 in at least 1% of cells. Patients should be at least 18 years old, have a life expectancy of at least 3 months, and be able to perform daily activities with an ECOG performance status of 0 to 3 before pre-treatment and 0 to 2 before randomization. The disease must be measurable with at least one tumor or lymph node measuring 1.5 cm or larger on a CT scan. Patients must have received at least one prior chemotherapy treatment and can have had a maximum of two previous treatments, including autologous stem cell transplantation. For patients with ALCL subtype, prior treatment with brentuximab vedotin is required.
Main exclusion criteria: Patients who have not experienced disease progression after previous treatment, those without confirmed peripheral T-cell lymphoma, those lacking the KIR3DL2 protein on their cancer cells, patients outside the specified age range, vulnerable populations, and those unable to receive the study treatment plan are excluded.
Focus and goal: The trial aims to compare the effectiveness of adding Lacutamab to standard GemOx chemotherapy versus GemOx alone. Participants are randomly assigned to receive either the combination treatment or GemOx alone. The study monitors how the cancer responds to treatment and assesses safety and potential side effects. Treatment is given in cycles through intravenous infusion, with a maintenance phase for those receiving Lacutamab.
Investigational drugs: Lacutamab is a monoclonal antibody that targets the KIR3DL2 protein on cancer cells, potentially helping the immune system recognize and destroy these cells. Gemcitabine and Oxaliplatin are chemotherapy medications that work by interfering with cancer cell growth and damaging their DNA.
Study on the Benefits of Autologous Stem Cell Transplantation for Patients with Peripheral T-cell Lymphoma Using Etoposide and Drug Combination
This study investigates whether autologous stem cell transplantation can help prolong the time patients remain free from cancer progression after achieving a complete response to initial chemotherapy.
Main inclusion criteria: Patients must be between 18 and 70 years old and have newly diagnosed nodal-type peripheral T-cell lymphoma that has not been previously treated. They must be fit enough to receive an autologous stem cell transplant and have adequate blood health, including hemoglobin greater than 8g/dL, neutrophil count greater than 0.5 G/L, and platelet count greater than 50 G/L. Patients must have Ann Arbor staging I-IV and be covered by a social security system. Both males and females must agree to use effective birth control methods during and after the study.
Main exclusion criteria: Patients who have not achieved a complete response after 6 cycles of induction chemotherapy, those who have not undergone a PET-CT or CT scan to confirm their response, those not diagnosed with the specific lymphoma type, patients outside the age range, and those unable to provide informed consent are excluded.
Focus and goal: The trial consists of an induction chemotherapy phase with six cycles of treatment using medications including Etoposide, Methylprednisolone, Prednisone, Brentuximab vedotin, Doxorubicin, Vincristine, and Cyclophosphamide. After achieving a complete response, patients undergo autologous stem cell transplantation, where their own stem cells are collected and reintroduced after intensive chemotherapy. The goal is to extend progression-free survival and evaluate overall survival rates.
Investigational drugs: Autologous Stem Cell Transplantation is the primary therapy being studied. This procedure involves collecting a patient’s own stem cells and giving them back after high-dose chemotherapy to help the body recover and produce healthy blood cells.
Study on the Effectiveness and Safety of Belinostat and Pralatrexate with Drug Combination for Newly Diagnosed Peripheral T-Cell Lymphoma Patients
This trial evaluates the safety and effectiveness of adding Belinostat or Pralatrexate to standard chemotherapy for newly diagnosed patients.
Main inclusion criteria: Patients must be at least 18 years old with newly diagnosed peripheral T-cell lymphoma that has not been previously treated. They must have measurable disease and an ECOG performance status of 2 or less. Adequate blood, liver, and kidney function is required, and the patient’s UGT1A1 genotype must be known. Patients must be willing to provide written consent and agree to use two forms of birth control. Women of childbearing potential must have a negative pregnancy test within four weeks before starting treatment.
Main exclusion criteria: Patients with a different type of cancer, those outside the specified age range, those not newly diagnosed, patients who cannot safely receive the study medications, and vulnerable populations that cannot be safely included are excluded.
Focus and goal: The study is conducted in two parts. Part one focuses on finding the best dose levels for Belinostat and Pralatrexate when combined with the CHOP chemotherapy regimen. Part two compares the effectiveness and safety of Bel-CHOP and Fol-COP combinations against CHOP alone. The primary goal is to improve progression-free survival. Treatment consists of up to six cycles delivered intravenously.
Investigational drugs: Beleodaq (Belinostat) is a histone deacetylase inhibitor combined with CHOP chemotherapy. Folotyn (Pralatrexate) is an antifolate chemotherapy agent combined with COP regimen. CHOP is a standard chemotherapy combination, and COP is similar but excludes one drug found in CHOP.
Study of Romidepsin and Drug Combination for Young Patients with Peripheral T-Cell Lymphomas Before Stem Cell Transplantation
This study evaluates the safety and effectiveness of combining Romidepsin with CHOEP chemotherapy as first-line treatment before stem cell transplantation.
Main inclusion criteria: Patients must be between 18 and 65 years old with newly diagnosed PTCL-NOS, AITL, or ALK negative ALCL at cancer stage II to IV. They must have no previous lymphoma treatment and adequate organ function, including heart function with ejection fraction greater than 50%, kidney function with creatinine clearance greater than 60 ml/min, and lung function with DLCO greater than 50%. Blood tests must show bilirubin, alkaline phosphatase, and transaminases less than twice the upper normal limit unless disease-related. Patients must be HIV negative, have no active HCV infection, and be HBV negative or meet specific conditions. Tissue samples must be available for review, and patients must provide signed informed consent.
Main exclusion criteria: Patients with other types of lymphoma, those with psychiatric illness preventing understanding of the trial, patients with significant heart problems, uncontrolled infections, or disease affecting the brain or spinal cord are excluded.
Focus and goal: The trial is divided into two phases. Phase I determines the maximum tolerated dose of Romidepsin combined with CHOEP chemotherapy. Phase II evaluates the effectiveness in preventing disease progression. The study monitors progression-free survival, overall survival, and objective response rates.
Investigational drugs: Romidepsin is a histone deacetylase inhibitor administered intravenously that interferes with cancer cell growth. CHOEP is a combination chemotherapy regimen including Cyclophosphamide, Doxorubicin, Vincristine, Etoposide, and Prednisone, each working through different mechanisms to stop cancer cell growth.
Study on Brentuximab Vedotin and Drug Combination for Patients with Peripheral T-cell Lymphoma with Less Than 10% CD30 Expression
This trial investigates a treatment combination including Brentuximab Vedotin for patients whose cancer cells have less than 10% CD30 expression.
Main inclusion criteria: Patients must be 18 years or older with peripheral T-cell lymphoma (excluding sALCL subtype) and have CD30 expression less than 10% in tumor samples. Eligible subtypes include PTCL-NOS, AITL, ATLL (acute and lymphoma types only, HTLV-1 positive), EATL, hepatosplenic T-cell lymphoma, MEITCL, indolent T-LPD of the GI tract, follicular T-cell lymphoma, and nodal PTCL with TFH phenotype. Patients must have disease visible on PET scan and measurable by CT scan (at least 1.5 cm). ECOG performance status must be 2 or less, with specific blood test requirements for bilirubin, liver enzymes, creatinine, and blood cell counts. HIV-positive patients must meet additional criteria including CD4+ count at least 350 cells/µL, no AIDS-defining infections in the past 12 months, and stable HIV treatment with viral load less than 400 copies/mL. Both males with partners who can become pregnant and females of childbearing potential must agree to use effective birth control.
Main exclusion criteria: Patients with other cancer types, those who have had another cancer within the last 5 years (except certain skin cancers), patients who received other cancer treatment within 4 weeks, those with uncontrolled infections, significant heart problems, pregnant or breastfeeding patients, those with known allergies to study medication, patients who participated in another clinical trial within 4 weeks, and those with conditions deemed unsafe by study doctors are excluded.
Focus and goal: The trial evaluates the effectiveness and safety of combining Brentuximab Vedotin with CHP chemotherapy. Treatment is given in cycles over six months through intravenous infusion (for Doxorubicin, Cyclophosphamide, and Brentuximab Vedotin) and oral tablets (for Prednisone). The study monitors cancer response, progression-free survival, and overall survival.
Investigational drugs: Brentuximab Vedotin is an antibody-drug conjugate that attaches to the CD30 protein on cancer cells and releases a substance to kill them. CHP is a combination of three chemotherapy drugs (Cyclophosphamide, Doxorubicin, and Prednisone) that work together to stop cancer cell growth.
Study on the Safety and Effects of Tolinapant in Patients with Advanced Solid Tumors and Lymphomas
This study evaluates the safety and effectiveness of Tolinapant in patients with advanced cancers, including peripheral T-cell lymphoma.
Main inclusion criteria: Patients must be 18 years or older with advanced solid tumors or lymphoma that cannot be surgically removed or has spread to other parts of the body, and for which no standard treatments are available. For certain study groups, patients must have specific types of T-cell lymphoma confirmed by pathology report and show evidence of disease progression after receiving at least two previous treatments. Patients must have measurable disease according to specific criteria and an ECOG performance status of 0, 1, or 2. Acceptable organ function must be demonstrated through laboratory tests including liver enzymes, bilirubin, blood cell counts, and kidney function. Women of childbearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test. Both women and men must agree to use two effective methods of birth control during the study and for at least three months after treatment ends.
Main exclusion criteria: Patients with other cancer types not included in the study, those who have not recovered from previous cancer treatments, patients with serious heart problems, uncontrolled infections, pregnant or breastfeeding patients, those who had another cancer within 3 years (except certain exceptions), patients with known allergies to study drug, those who received another investigational drug within 4 weeks, patients with serious medical conditions that could interfere with the study, and those unable to follow study procedures are excluded.
Focus and goal: The study aims to determine the safety, best dose, and dosing schedule of Tolinapant. Participants receive the medication as oral capsules. The trial monitors tumor response, including whether the medication can reduce tumor size or slow growth. Some participants may receive a placebo for comparison purposes. The study is expected to continue until the end of 2025.
Investigational drugs: ASTX660 (Tolinapant) is a small molecule inhibitor that works by blocking specific proteins that help cancer cells survive, thereby promoting cancer cell death. It is administered orally and is currently in early stages of research.
Summary
The six ongoing clinical trials for peripheral T-cell lymphoma unspecified represent diverse approaches to treating this challenging disease. The studies are primarily concentrated in Western European countries, with Italy, Spain, and France hosting the most trials. Several trials focus on newly diagnosed patients, evaluating combinations of novel agents with standard chemotherapy regimens, while others target relapsed or refractory disease.
A notable pattern is the investigation of targeted therapies such as monoclonal antibodies (Lacutamab, Brentuximab Vedotin) and histone deacetylase inhibitors (Belinostat, Romidepsin), often combined with established chemotherapy protocols like CHOP. The role of autologous stem cell transplantation as a consolidation strategy is also being evaluated. These trials reflect ongoing efforts to improve outcomes for patients with this rare and aggressive lymphoma through innovative treatment combinations and personalized approaches based on disease markers such as KIR3DL2 and CD30 expression.
