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Haploidentical Transplantation in Severe Aplastic Anemia

W

Wu Xiaoxiong

Status

Unknown

Conditions

Severe Aplastic Anemia

Treatments

Other: HFD-HSCT
Other: MSD-HSCT

Study type

Interventional

Funder types

Other

Identifiers

NCT03246178
2016QX-KS008

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

MSD-HSCT
Other group
Description:
This group received treatment of matched sibling donor - hematopoietic stem cell transplantation (MSD-HSCT).
Treatment:
Other: MSD-HSCT
HFD-HSCT
Experimental group
Description:
This group received treatment of haploid family donor - hematopoietic stem cell transplantation (HFD-HSCT).
Treatment:
Other: HFD-HSCT

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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