Clinical trial · Interventional
Clinical Study of rATG Individualized Administration in Haploidentical Hematopoietic Stem Cell Transplantation
Clinical Study of rATG Individualized Administration for Prevention of GVHD and Maintenance of GVL in Haploidentical Hematopoietic Stem Cell Transplantation.
NCT05634915CI-TRIAL-00063964unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this prospective, open-label, pairing design, single-center study is to evaluate the effect of individualized rATG dosing vs traditional weight-based rATG dosing regimen（10mg/kg）for patients with acute leukemia undergoing a myeloablative conditioning regimen and haploidentical hematopoietic stem cell transplantation (haplo-HSCT).
Conditions
Conditions (2)
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 |
| Hematopoietic Stem Cell Transplantation | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ATG | Drug | — | UNRESOLVED |
| Individual ATG | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Individual dose of ATG
- description
- The total individual ATG dose was calculated based on population pharmacokinetic modeling. ATG was intravenously infused every day from day -5 to day -2.
- interventionNames
- Drug: Individual ATG
- type
- ACTIVE_COMPARATOR
- label
- ATG 10mg/kg
- description
- The total ATG dose was 10mg/kg. ATG was intravenously infused every day from day -5 to day -2.
- interventionNames
- Drug: ATG
Primary outcomes (3)
- measure
- Cumulative incidences of aGVHD
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. All patients were diagnosed with acute leukemia. 2. All patients should have the indication of Haploidentical hematopoietic stem cell transplant and receive the myeloablative conditioning regimen. 3. All patients should sign an informed consent document indicating that they understand the purpose of and procedures required for the study and be willing to participate in the study. Exclusion Criteria: Patients with any conditions not suitable for the trial (investigators' decision).
References
Publications (0)
Data not yet available
No reference posted for this study.