Liasny

Researchers are evaluating the effectiveness of immunotherapy using ex vivo expanded haploidentical natural killer NK cells as a consolidation treatment for children and young adults with intermediate risk acute myeloid leukemia AML. This study focuses on improving outcomes by using high doses or multiple infusions of NK cells after chemotherapy. It is a Phase 1 and Phase 2 clinical trial sponsored by the Belarusian Research Center for Pediatric Oncology, Hematology and Immunology. The treatment involves a chemotherapy cycle using cyclophosphamide and fludarabine, followed by two intravenous infusions of expanded haploidentical NK cells. These NK cells are grown in the lab with a special feeder cell line to increase their number and effectiveness. Patients receive two doses of these NK cells, ranging from 30 to 100 million cells per kilogram of body weight, after chemotherapy. Participants will be monitored for relapse-free survival and overall survival over two years. Additional assessments include tracking the persistence of donor NK cells 21 days after the first infusion and measuring various immune cells 28 days post-infusion. Throughout the study, researchers will evaluate immune response and safety, with participation lasting through these follow-up periods.

Researchers are evaluating the effectiveness of immunotherapy using ex vivo expanded haploidentical natural killer NK cells in children and young adults with primary high risk, refractory, or relapsed acute myeloid leukemia AML. This study aims to improve treatment outcomes by using high doses or multiple infusions of NK cells. The trial is a Phase 12 interventional study sponsored by the Belarusian Research Center for Pediatric Oncology, Hematology and Immunology. The immunotherapy involves expanding donor NK cells with a specific feeder cell line before infusion. For patients with high-risk primary AML, treatment includes chemotherapy with HD-ARA-C and IDA, followed by three intravenous infusions of expanded haploidentical NK cells. Patients with refractory or relapsed AML receive chemotherapy with fludarabine, cytarabine, and G-CSF FLAG, followed by the same NK cell infusion schedule. If eligible, a second therapy cycle may be given. Participants will be monitored for responses 30 days after each NK cell immunotherapy course, including measuring objective response rate, leukemia-free survival, and overall survival at one year. Additional assessments include the duration of NK cell persistence and immune cell counts after infusion. The study involves written consent and performance status evaluation, with treatment and follow-up extending up to a year to assess long-term outcomes.

Researchers are evaluating the effects of different extents of lymph node dissection performed alongside radical prostatectomy in men with localized or locally advanced prostate cancer. This randomized controlled study aims to compare outcomes between limited or no lymph node removal and extended lymph node removal during surgery. The goal is to optimize the volume of lymph node removal in these patients to better understand its impact on long-term survival and complications. Participants will be randomly assigned to receive either radical prostatectomy with limited or no lymph node dissection or radical prostatectomy with extended lymph node dissection. The extent of lymph node removal depends on the patients prostate cancer risk category, with extended dissection including more lymph nodes for higher-risk patients. The study tracks surgical details such as blood loss and surgery duration, as well as postoperative complications and length of hospital stay. During the study, participants will be followed for up to 5 to 7 years after surgery. Researchers will monitor metastasis-free survival as the primary outcome, along with secondary outcomes including biochemical recurrence-free survival, prostate cancer-specific survival, overall survival, and perioperative events. Follow-up visits will assess recovery, complications, and hospital stay length. The study involves careful evaluation of long-term cancer outcomes and surgical safety in men undergoing radical prostatectomy.

This research aims to estimate the safety and effectiveness of CD19 CAR-T cell immunotherapy in children and young adults with relapsed or refractory B-cell acute lymphoblastic leukemia or lymphoblastic B-cell lymphoma. The study focuses on patients aged 1 to 30 years and is sponsored by the Belarusian Research Center for Pediatric Oncology, Hematology and Immunology. It is a phase 1 interventional trial designed to evaluate this promising immunotherapy approach in this patient population. Participants receive a cycle of lymphodepleting chemotherapy using fludarabine and cyclophosphamide, followed by a single intravenous infusion of locally produced autologous CD19 CAR-T cells. Before the CAR-T cell infusion, patients are given tocilizumab as premedication to help manage immune responses. The treatment process includes close monitoring during and after infusion. Throughout the study, participants undergo regular assessments to monitor treatment-emergent adverse events within one month, and responses are evaluated 28 days after CAR-T cell infusion. Researchers also track overall survival, event-free survival, and leukemia-free survival over one year. Safety monitoring, laboratory tests, and clinical evaluations support participant care during the trial, which aims to provide comprehensive data on this therapys impact and safety over time.

Researchers are evaluating the use of academic anti-CD19 CAR-T cell therapy for patients with relapsed or refractory large B-cell lymphoma LBCL. This observational study aims to assess the effectiveness and safety of a CAR-T cell product made using a lentiviral vector encoding the anti-CD19 CAR in a real-world clinical setting. The study is conducted at the NN Alexandrov National Cancer Centre of Belarus and focuses on patients who have already received prior anti-tumor therapy. The academic CAR-T cell therapy studied encodes an anti-CD19 CAR construct with a specific antibody fragment FMC63 linked to several components for activation and safety, including a safety switch marker. This therapy is administered to patients with confirmed CD19 expression in their tumor tissue. The study observes the treatment as it is given in routine practice without altering the approach. Participants are monitored for response 30 days after CAR-T infusion, focusing on the overall response rate. Secondary outcomes include event-free survival and overall survival measured over five years. Patient evaluations include confirming eligibility based on disease status and prior treatment history. The study tracks safety and outcomes over a long-term period up to five years, with participation lasting from treatment through extended follow-up.