Clinical trial · Observational
Haploidentical Peripheral Blood Stem Cell Transplantation for Acute Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Allogeneic stem cell transplantation (Allo-HSCT) is the effective and even the only treatment for hematological malignancies. The "GIAC" protocol established by our center has successfully crossed the HLA barrier in HLA-mismatched/haploidentical HSCT. The protocol entails the following: treating donors with granulocyte colony-stimulating factor (G-CSF) to induce donor immune tolerance, intensified immunologic suppression to both promote engraftment and to prevent GVHD, antithymocyte globulin (ATG) was included for the prophylaxis of GVHD and graft rejection, and combination of G-CSF-primed bone marrow harvest (G-BM) and G-CSF-mobilized peripheral blood stem cell harvest (G-PB) as the source of stem cell grafts. But peripheral blood transplantation is still prevalent. Compared with BM, G-PB is more convenient to collect, and the number of T lymphocytes and CD34+ cells is higher. It is reported that G-PB has a higher implantation rate and even a higher disease-free survival rate in sibiling-identical transplantation compared with BM transplantation, whereas there were also reports with different conclusions. This prospective, one-arm clinical cohort study aims to evaluate the safety and efficacy of haplotype peripheral blood stem cell transplantation (PBSCT) in the treatment of acute leukemia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Leukemia | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| haplotype PBSCT | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- haplotype PBSCT group
- description
- Subjects in this group will receive haplotype peripheral blood stem cell transplantation (PBSCT) of "GIAC" system in the treatment of acute leukemia.
- interventionNames
- Other: haplotype PBSCT
Primary outcomes (1)
- measure
- engraftment rate
- timeFrame
- one year after transplantation
- description
- Neutrophil recovery was defined as an absolute neutrophil count(ANC) of 0.5×10\^9/L or more for three consecutive days and platelet recovery, as 20×10\^9/L or more for seven consecutive days without transfusion.
Secondary outcomes (5)
- measure
- cumulative incidence of acute graft-versus-host disease(GVHD)
- timeFrame
- one year after transplantation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * 2-60 years old, all genders; * the first complete remission phase (CR1) of acute leukemia; * planning to receive haplotype PBSCT; * no uncontrolled current infections (new infections, body temperature still above 38 ℃ after treatment with broad-spectrum antibiotics for 72h, except for other non-infectious factors); * no organ failure. Exclusion Criteria: * with poor compliance; * with uncontrolled current infections; * pregnancy; * donors with contraindications of mobilization and collection of peripheral blood stem cells; * with mental sickness
References
Publications (3)
- DERIVEDShen MZ, Hong SD, Lou R, Chen RZ, Zhang XH, Xu LP, Wang Y, Yan CH, Chen H, Chen YH, Han W, Wang FR, Wang JZ, Liu KY, Huang XJ, Mo XD. A comprehensive model to predict severe acute graft-versus-host disease in acute leukemia patients after haploidentical hematopoietic stem cell transplantation. Exp Hematol Oncol. 2022 May 3;11(1):25. doi: 10.1186/s40164-022-00278-x. PMID 35505384
- DERIVEDShen MZ, Hong SD, Wang J, Zhang XH, Xu LP, Wang Y, Yan CH, Chen H, Chen YH, Han W, Wang FR, Wang JZ, Liu KY, Huang XJ, Mo XD. A Predicted Model for Refractory/Recurrent Cytomegalovirus Infection in Acute Leukemia Patients After Haploidentical Hematopoietic Stem Cell Transplantation. Front Cell Infect Microbiol. 2022 Mar 22;12:862526. doi: 10.3389/fcimb.2022.862526. eCollection 2022. PMID 35392613
- DERIVEDMa YR, Zhang X, Xu L, Wang Y, Yan C, Chen H, Chen Y, Han W, Wang F, Wang J, Liu K, Huang X, Mo X. G-CSF-Primed Peripheral Blood Stem Cell Haploidentical Transplantation Could Achieve Satisfactory Clinical Outcomes for Acute Leukemia Patients in the First Complete Remission: A Registered Study. Front Oncol. 2021 Mar 15;11:631625. doi: 10.3389/fonc.2021.631625. eCollection 2021. PMID 33791217