Risk Stratification Directed Conditioning Regimen for Haploidentical HSCT in SAA

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03821987
• Date of registration: 23/01/2019
• Prospective Registration: No
• Primary sponsor: Peking University People's Hospital
• Public title: Risk Stratification Directed Conditioning Regimen for Haploidentical HSCT in SAA
• Scientific title: Risk Stratification Directed Conditioning Regimen for Haploidentical HSCT in SAA
• Date of first enrolment: December 17, 2018
• Target sample size: 55
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03821987
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

China

Contacts

• Name: Lanping Xu, Prof.

• Name: Xiaojun Huang, Prof.

• Name: Xiaojun Huang, Prof.
• Affiliation: Peking Universiy Institute of Hematology,People's Hospital Pekiking Universiyy

Key inclusion & exclusion criteria

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



Age minimum: 3 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Aplastic Anemia

Engraft Failure

Stem Cell Transplant Complications

Intervention(s)

Drug: Fludarabine

Primary Outcome(s)

1 year cumulative incidence overall survival [Time Frame: 1 year post HSCT]

Secondary Outcome(s)

Engraftment [Time Frame: 1 month post HSCT]

failure-free survival [Time Frame: 1 year post HSCT]

0ne month regimen-related toxicity [Time Frame: 1 month post HSCT]

aGVHD [Time Frame: 100 days post HSCT]

one month Transplantation related mortality [Time Frame: 1 month post HSCT]

Secondary ID(s)

PUIH-SAA

Source(s) of Monetary Support

Please refer to primary and secondary sponsors