---
title: Effect of Donor Chose on the Outcomes of GVHD Prophylaxis Underwent the Combined Treatment of ATG/PTCy for Haplo-HSCT
nct_id: NCT06686173
overall_status: NOT_YET_RECRUITING
sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
study_type: OBSERVATIONAL
primary_condition: High-Risk Acute Myeloid Leukemia
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06686173.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06686173"
ct_last_update_post_date: 2025-01-07
last_seen_at: "2026-05-12T07:05:08.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Effect of Donor Chose on the Outcomes of GVHD Prophylaxis Underwent the Combined Treatment of ATG/PTCy for Haplo-HSCT

**Official Title:** The Effect of the Parous Female and Young Male Donor on the Outcomes of GVHD Prophylaxis Underwent the Combined Treatment of ATG and PTCy for Haplo-HSCT: a Prospective, Multi-center, Cohort Study

**NCT ID:** [NCT06686173](https://clinicaltrials.gov/study/NCT06686173)

## Key Facts

- **Status:** NOT_YET_RECRUITING
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 114
- **Lead Sponsor:** Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- **Conditions:** High-Risk Acute Myeloid Leukemia, Relapse And/or Refractory AML
- **Start Date:** 2025-02-01
- **Completion Date:** 2028-02-01
- **CT.gov Last Update:** 2025-01-07

## Brief Summary

This is a prospective, multicenter, cohort study. The high-risk, relapse and refractory AML patients were enrolled in this study. And the goal of this study is to study the effect of the parous female donor and young male donor on the outcomes of graft-versus-host disease (GVHD) prophylaxis underwent the combination of ATG and PTCy for haploidentical peripheral blood stem cell transplantation

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 55 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

1\. Acute myeloid leukemia was diagnosed according to the 2016ELN criteria with any of the following:

1. ELN prognostic stratification high-risk group (see Appendix for criteria)
2. Non-remission (NR) AML: including primary refractory AML and NR patients after relapse.

2\. Patients must have a suitable hematopoietic stem-cell donor.

1. Patients had to have a qualified haploidentical young male (≤30 years old) or female with a history of pregnancy;
2. Related donors had to be related donors matched 5/10-7/10 for HLA-A, -B, -C, -DQB1 and -DRB1 3. All the enrolled patients received a unified GVHD prevention regimen based on ATG and PTCy

Exclusion Criteria:

1. Intermediate-low risk AML patients (ELN criteria);
2. Patients with extramedullary active lesions at the time of transplantation;
3. Haploidentical collateral donors;
4. Patients who refused allogeneic hematopoietic stem cell transplantation;
```

## Interventions

- **None-placebo** (OTHER) — This is one kind descriptive study. The different donor groups made the cohorts different: the parous female donor and young male donor
- **non-intervention study** (OTHER) — This study is one kind of non intervention study
- **donor selection** (OTHER) — the intervention of this study was the different donor groups: the parous female donor and young male donor. All the patients involved in this study were treated by the combination of ATG and PTCy

## Primary Outcomes

- **RFS** _(time frame: one year)_ — 1-year RFS after transplantation

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06686173.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06686173*  
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