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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03821987
Other study ID # PUIH-SAA
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 17, 2018
Est. completion date March 30, 2022

Study information

Verified date March 2020
Source Peking University People's Hospital
Contact Xiaojun Huang, Prof.
Phone 861088326006
Email lpxu_0415@sina.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 55
Est. completion date March 30, 2022
Est. primary completion date December 30, 2021
Accepts healthy volunteers No
Gender All
Age group 3 Years to 55 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Fludarabine
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.

Locations

Country Name City State
China Peking University Institute of Hematology,People's hospital Peking University Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 1 year cumulative incidence overall survival Tne cumulative incidence of overall survival at 1 year post HSCT 1 year post HSCT
Secondary one month Transplantation related mortality Tne cumulative incidence of transplantation related motality at 1 month post HSCT 1 month post HSCT
Secondary Engraftment Tne cumulative incidence of engraftment at 1 moths post HSCT 1 month post HSCT
Secondary 0ne month regimen-related toxicity Tne cumulative incidence of regimen related toxicity at 1 month post HSCT 1 month post HSCT
Secondary aGVHD Tne cumulative incidence of acute GVHD at Day 100 post HSCT 100 days post HSCT
Secondary failure-free survival The cumulative incidence of failure-free survival at 1year post HSCT 1 year post HSCT
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