Ongoing Clinical Trials for Adult T-cell Lymphoma/Leukaemia
Currently, there are 2 ongoing clinical trials investigating treatment options for adult T-cell lymphoma/leukaemia. These trials are exploring different combinations of medications aimed at improving outcomes for patients with various forms of this disease. Both studies are being conducted in Italy and involve innovative treatment approaches combining targeted therapies with established chemotherapy regimens.
Clinical trial locations
- Italy
Study on Acalabrutinib and R-CHOP for Patients with Diffuse Large B-Cell Lymphoma (DLBCL)
This trial is investigating a combination treatment approach for patients with Diffuse Large B-Cell Lymphoma, a type of aggressive non-Hodgkin lymphoma. The study focuses on combining a targeted medication called Acalabrutinib with the standard R-CHOP chemotherapy regimen.
Main inclusion criteria: Participants must be at least 18 years old with a confirmed diagnosis of previously untreated DLBCL that is suitable for R-CHOP treatment. The disease must be measurable and at a certain stage of progression. Patients need to have adequate blood clotting, bone marrow, liver, kidney, and heart function. Those who can have children must agree to use effective birth control during the study and for 12 months afterward. Participants must be able to swallow the study medication whole and be willing to provide samples for research purposes. Previous cancer treatment is acceptable if it was completed at least 2 years ago with no evidence of disease, or less than 2 years for cancers with low risk of returning.
Main exclusion criteria: The trial excludes patients with other types of cancer that are not DLBCL, those who don’t show a molecular response after two courses of R-CHOP treatment, patients with positive PET/CT scans showing inadequate response, and those unable to follow study procedures or attend required visits.
Focus and goal: The study aims to evaluate how well Acalabrutinib works when combined with R-CHOP, particularly in patients with specific genetic changes such as MYD88 L265P and CD79A/B mutations. These genetic alterations can affect how the cancer behaves and responds to treatment. The trial will assess treatment effectiveness through imaging tests like PET/CT scans and blood tests measuring cancer DNA fragments. Different patient groups may receive varying treatment approaches based on their initial response, with treatment potentially lasting up to 18 months. The study will monitor disease progression, overall survival, and any side effects experienced during treatment.
Investigational drugs: Acalabrutinib is the main investigational drug being tested. It works by blocking a specific protein called Bruton’s tyrosine kinase, which helps cancer cells grow and survive. This targeted therapy is being combined with R-CHOP, a standard chemotherapy combination that includes rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone. These medications work together to kill cancer cells and prevent them from multiplying.
Study of Selinexor, Ifosfamide, Etoposide, and Dexamethasone for Patients with Relapsed or Refractory Peripheral T-cell Lymphomas
This trial focuses on testing a four-drug combination for patients whose Peripheral T-cell Lymphoma has either returned after treatment or hasn’t responded to previous therapies. The study combines Selinexor with three other established cancer medications.
Main inclusion criteria: Eligible participants must be between 18 and 75 years old with a confirmed diagnosis of specific types of T-cell lymphomas according to WHO 2016 classification. The disease must have relapsed or not responded to at least one previous treatment that included an anthracycline drug. Patients need measurable disease visible on CT or MRI scans and a life expectancy of at least 3 months. Normal organ function is required, including proper kidney, heart, and liver function. Laboratory values for blood cells, liver, and kidney function must meet specific requirements. Tumor tissue samples must be available either from past tests or newly collected. Those of childbearing potential must use effective birth control or abstain from sexual activity during the study and for 90 days after the last dose. Participants must be willing to meet all study requirements and attend follow-up appointments.
Main exclusion criteria: The study excludes patients younger than 18 or older than 65 years, those who are pregnant or breastfeeding, patients with central nervous system involvement at enrollment, those with a history of psychiatric disease, and individuals unable to safely take the study medications. Patients with other serious health conditions that could interfere with the study or make participation unsafe are also excluded, as are those currently participating in another clinical trial.
Focus and goal: The trial aims to determine how effective this four-drug combination is in treating relapsed or refractory Peripheral T-cell Lymphomas. After completing four treatment cycles, researchers will evaluate the overall response rate, looking for both complete disappearance of cancer and partial reduction in tumor size. The study will monitor participants closely throughout each treatment cycle to assess response and manage side effects. Long-term follow-up will track progression-free survival and overall survival, with adverse events recorded according to established guidelines.
Investigational drugs: Selinexor is the primary investigational drug, taken orally as film-coated tablets. It works by blocking proteins that help cancer cells grow and survive, potentially leading to cancer cell death. Ifosfamide, administered through infusion, interferes with cancer cell DNA to prevent growth and division. Etoposide, given as a concentrated solution for infusion, damages cancer cell DNA to stop their growth. Dexamethasone, a steroid medication provided as an injection, helps reduce inflammation and suppress the immune system while managing side effects and potentially improving treatment effectiveness.
Summary
Both ongoing clinical trials for adult T-cell lymphoma/leukaemia are being conducted in Italy, indicating a concentration of research activity in this region. The trials represent different approaches to treating lymphomas: one focuses on previously untreated patients with a specific type of B-cell lymphoma using targeted therapy combined with standard chemotherapy, while the other addresses patients whose disease has returned or not responded to treatment, testing a novel four-drug combination for T-cell lymphomas.
The studies reflect current trends in cancer research, combining newer targeted medications with established chemotherapy regimens to potentially improve treatment outcomes. Both trials emphasize careful patient selection based on specific disease characteristics and previous treatment history, and both require comprehensive monitoring throughout the treatment process to assess effectiveness and safety.
