Risk Stratification Directed Conditioning Regimen for Haploidentical HSCT in SAA

Not Applicable

• Conditions: Engraft Failure; Aplastic Anemia; Stem Cell Transplant Complications
• Interventions: Drug: Fludarabine

• Registration Number: NCT03821987
• Lead Sponsor: Peking University People's Hospital

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.

Study Timeline

• Study Start: 2018-12-17
• Study First Submitted: 2019-01-23
• Study First Submitted QC: 2019-01-26
• Study First Posted: 2019-01-30
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-10
• Primary Completion: 2021-12-30
• Study Completion: 2022-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BFCA regimen	Fludarabine	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.

Primary Outcome Measures

Name	Time	Method
1 year cumulative incidence overall survival	1 year post HSCT	Tne cumulative incidence of overall survival at 1 year post HSCT

Secondary Outcome Measures

Name	Time	Method
Engraftment	1 month post HSCT	Tne cumulative incidence of engraftment at 1 moths post HSCT
0ne month regimen-related toxicity	1 month post HSCT	Tne cumulative incidence of regimen related toxicity at 1 month post HSCT
one month Transplantation related mortality	1 month post HSCT	Tne cumulative incidence of transplantation related motality at 1 month post HSCT
failure-free survival	1 year post HSCT	The cumulative incidence of failure-free survival at 1year post HSCT
aGVHD	100 days post HSCT	Tne cumulative incidence of acute GVHD at Day 100 post HSCT

Trial Locations

Locations (1)

Peking University Institute of Hematology,People's hospital Peking University; 🇨🇳 Beijing, Beijing, China