Haploidentical Transplantation in Severe Aplastic Anemia

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Brief Title

Haploidentical Transplantation in Severe Aplastic Anemia

Official Title

A Research on Haploidentical Transplantation in Severe Aplastic Anemia Using Reduced-intensity Fludarabine-based Conditioning

Brief Summary

      This is a prospective case-control study on SAA patients treated with HSCT, order to further
      discuss and assess the safety, feasibility and effectiveness of HFD-HSCT which performed with
      reduced-intensity fludarabine-based conditioning regimen.Our findings would indicate that SAA
      patients who lack MSD benefited most if HFD-HSCT was performed with reduced-intensity
      fludarabine-based conditioning regimen, and our improved outcomes with HFD-HSCT may lead to a
      salvaged therapy and an expanded direct role for SAA in the future.

Study Type

Interventional

Primary Outcome

Engraftment

Condition

Severe Aplastic Anemia

Intervention

MSD-HSCT

Study Arms / Comparison Groups

 MSD-HSCT
Description:  This group received treatment of matched sibling donor - hematopoietic stem cell transplantation (MSD-HSCT).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Other

Estimated Enrollment

60

Start Date

July 10, 2017

Completion Date

December 1, 2020

Primary Completion Date

July 1, 2020

Eligibility Criteria

        Inclusion Criteria:

        (i) Diagnosis of SAA, very SAA or SAA and paroxysmal nocturnal hemoglobinuria (PNH)
        according to the International Aplastic Anemia Study Group; (ii) SAA patients no response
        to previous IST; (iii) adequate performance status [Eastern Cooperative Oncology Group
        (ECOG) score 0-2].

        Exclusion Criteria:

        (i) Congenital forms of aplastic anemia; (ii)Patients with any severe pulmonary, cardiac,
        liver, or renal diseases or active infection.

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Xiaoxiong WU, PhD, ,

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT03246178

Organization ID

2016QX-KS008

Responsible Party

Sponsor-Investigator

Study Sponsor

Wu Xiaoxiong

Study Sponsor

Xiaoxiong WU, PhD, Study Director, The First Affiliated Hospital of General Hospital of PLA

Verification Date

August 2017