Phase 1 Study of Chemotherapy Combined With HLA-mismatched GPBMC Infusion as a Bridge to Allogeneic Stem Cell Transplantation for Relapsed or Refractory Leukemia

What this Trial Is About

Researchers are evaluating a combination treatment involving chemotherapy and infusion of HLA-mismatched granulocyte colony-stimulating factor G-CSF mobilized peripheral blood mononuclear cells GPBMCs as a bridge to allogeneic hematopoietic stem cell transplantation allo-HSCT for patients with relapsed or refractory leukemia. This Phase 1 study aims to assess the safety, tolerability, and early effectiveness of this approach, with a focus on reducing leukemia burden before transplantation. The study is sponsored by Beijing 302 Hospital and will follow patients for outcomes related to adverse events and survival. Participants will first receive chemotherapy regimens that may include drugs such as fludarabine, cytarabine, venetoclax, and others, combined with infusion of HLA-mismatched GPBMCs from a sibling or unrelated donor. After this initial step, patients will undergo allo-HSCT using stem cells from an HLA-matched sibling, haploidentical, or unrelated donor. The transplantation process includes conditioning treatments and medications to prevent graft-versus-host disease GVHD. During the study, participants will be closely monitored for treatment-related side effects including GVHD, infections, organ dysfunction, and blood-related toxicities up to two years after transplant. Researchers will also assess survival outcomes and disease progression for up to four years. The study includes regular evaluations such as clinical exams and laboratory tests to track participants health and response to therapy throughout the treatment and follow-up periods.

Phase 1 Study of Chemotherapy Plus HLA-mismatched GPBMC Infusion Bridging to Allo-HSCT for R/R Leukemia