RecruitingPhase 1NCT07297173

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

Phase 1 Study of Chemotherapy Combining With HLA-mismatched G-CSF Mobilized Peripheral Blood Mononuclear Cell Infusion as a Bridge to Allogeneic Hematopoietic Stem Cell Transplantation for Relapsed and Refractory Leukemia

Sponsor

Beijing 302 Hospital

Enrollment

5 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

Relapsed Leukemia Refractory Leukemia

Summary

This is a Phase 1 clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of chemotherapy combining with HLA-mismatched G-CSF mobilized peripheral blood mononuclear cell (GPBMC) infusion as a bridging therapy to allogeneic hematopoietic stem cell transplantation (allo-HSCT) in patients with relapsed and refractory (R/R) leukemia.

Eligibility

Min Age: 15 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether giving chemotherapy combined with an infusion of donor blood stem cells (from a partially matched donor) can prepare patients with relapsed or treatment-resistant leukemia for a full stem cell transplant. **You may be eligible if...** - You are 15 years or older - You have leukemia that has returned or is not responding to treatment - Your liver and kidney function meet the required levels - You are willing to proceed toward a stem cell transplant **You may NOT be eligible if...** - You have an active, uncontrolled infection - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding - You have had a prior stem cell transplant recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREChemotherapy

Available chemotherapy regimens include but not limited to FLAG (fludarabine, cytarabine, G-CSF), DAV (daunorubicin, cytarabine, venetoclax), IAV (idarubicin, cytarabine, venetoclax), VDCP (vincristine, daunorubicin, cyclophosphamide, prednisone), hyper-CVAD A (cyclophosphamide, vincristine, doxorubicin, dexamethasone), FC (fludarabine and cyclophosphamide), et al.

BIOLOGICALHLA-mismatched GPBMC infusion

HLA-mismatched GPBMCs are infused following chemotherapy.

PROCEDUREAllogeneic Stem Cell Transplantation

Patients receive conditioning including but not limited to fludarabine, cyclophosphamide, antithymocyte globulin (ATG), and total body irradiation (TBI). HLA-matched sibling/haploidentical/unrelated GPBMCs are infused at day 0. Post-transplant cyclophosphamide, tacrolimus/cyclosporin, and mycophenolate mofetil are administered as graft-versus-host disease prophylaxis.

Locations(1)

Department of Hematology, the Fifth Medical Center of Chinese PLA General Hospital

Beijing, China

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NCT07297173

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