---
title: Risk Stratification Directed Conditioning Regimen for Haploidentical HSCT in SAA
nct_id: NCT03821987
overall_status: UNKNOWN
phase: NA
sponsor: "Peking University People's Hospital"
study_type: INTERVENTIONAL
primary_condition: Aplastic Anemia
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03821987.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03821987"
ct_last_update_post_date: 2020-03-10
last_seen_at: "2026-05-12T07:26:15.313Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Risk Stratification Directed Conditioning Regimen for Haploidentical HSCT in SAA

**NCT ID:** [NCT03821987](https://clinicaltrials.gov/study/NCT03821987)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 55
- **Lead Sponsor:** Peking University People's Hospital
- **Conditions:** Aplastic Anemia, Stem Cell Transplant Complications, Engraft Failure
- **Start Date:** 2018-12-17
- **Completion Date:** 2022-03-30
- **CT.gov Last Update:** 2020-03-10

## Brief Summary

The haplotype HSCT system including Bu(0.8mg/kg Q6hx2d)CTX(50mg/kgx4d)rATG(2.5mg/kgx4d) , established in Institute of Hematology of Peking University ,has been evaluated to be effective for acquired SAA.But some patients with high risk factors may not tolerate CTX 200mg/kg,alternative conditioning regimen including Bu/Fludarabine/dercreased CTX was studied in this trial.

## Detailed Description

Patients enrolled in this study would receive Bu (IV)0.8mg/kg Q6hx2d,Fludarabine 30mg/m2x5d ,CTX(cyclophosphamide) 25mg/kg/dx4d,rATG (thymoglobulin,Sang Stat,France) 2.5mg/kg/dx4d.

BM or Blood samples from patients were obtained to assess engraftment and chimerism after HSCT. The time point that investigators monitor BM or blood samples at 1 month,2 months, 3 months,6 months, 9 months and 1year,2years,3years 5 years after HSCT.

## Eligibility

- **Minimum age:** 3 Years
- **Maximum age:** 55 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
A：inclusion criteria

1. Patients diagnosed as acquired severe aplastic anemia(SAA) /very vSAA
2. patients with age 3-55 years
3. patients have no matched sibling donor
4. Patients have no matched unrelated donor
5. patients have no severe infection
6. Patients have no severe organ dysfunction
7. patients have risk factors of potential intolerance to previous condition regimen including BuCy(200mg/kg)and ATG
8. Consent form signed

B. Exclusion criteria ：

1. patients with congenital SAA/vSAA
2. patients with age\< 3years or \>55 years
3. patients with matched sibling donor
4. patients with matched URD
5. patients with severe infection
6. patients with severe organ dysfunction
7. pregnancy women
8. no Consent form signed
```

## Arms

- **BFCA regimen** (EXPERIMENTAL) — Detail: Patients enrolled in this study would receive Busulfan(B) (IV)0.8mg/kg Q6hx2d,Fludarabine(F) 30mg/m2x5d ,cyclophosphamide(C) 25mg/kg/dx4d,thymoglobulin (A :rATG ,Sang Stat,France) 2.5mg/kg/dx4d.

BM or Blood samples from patients were obtained to assess engraftment and chimerism after HSCT. The time point that we monitored BM or blood samples included at 1 month,2 months, 3 months,6 months, 9 months and 1year,2years,3years 5 years after HSCT.

## Interventions

- **Fludarabine** (DRUG) — Patients enrolled in this study would receive Bu (IV)0.8mg/kg Q6hx2d,Fludarabine 30mg/m2x5d ,CTX (cyclophosphamide) 25mg/kg/dx4d,rATG (thymoglobulin,Sang Stat,France) 2.5mg/kg/dx4d.

## Primary Outcomes

- **1 year cumulative incidence overall survival** _(time frame: 1 year post HSCT)_ — Tne cumulative incidence of overall survival at 1 year post HSCT

## Secondary Outcomes

- **one month Transplantation related mortality** _(time frame: 1 month post HSCT)_
- **Engraftment** _(time frame: 1 month post HSCT)_
- **0ne month regimen-related toxicity** _(time frame: 1 month post HSCT)_
- **aGVHD** _(time frame: 100 days post HSCT)_
- **failure-free survival** _(time frame: 1 year post HSCT)_

## Locations (1)

- Peking University Institute of Hematology,People's hospital Peking University, Beijing, Beijing Municipality, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `outcomes.secondary` — added _(2026-05-12)_
- `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.phases` — 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.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.peking university institute of hematology,people's hospital peking university|beijing|beijing municipality|china` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT03821987*  
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