Conditioning Regimen Containing Low Dose ATG for The Treatment of Acquired Severe Aplastic Aplasia Receiving Single Cord Blood Transplant: A Multi-center, Single-arm Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

To evaluate the safety and efficacy of Single Umbilical Cord blood transplantation (sUCBT) containing low dose ATG based conditioning regimen in the treatment of acquired Severe Aplastic Anemia (SAA).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 50
Healthy Volunteers: f
View:

• Patients diagnosed with severe aplastic anemia who do not respond to initial diagnosis or immunosuppressive therapy;

• Patients meet diagnostic criteria for severe aplastic anemia (Camitta criteria);

• Age from 1 to 50 years old, male or female;

• Patients without HLA-matched sibling or unrelated donors avaliable;

• Patients who have undergone unrelated cord blood transplantation need to have HLA high-resolution matching、TNC (before cord blood freezing)≥3.0×107/kg、CD34+(before cord blood freezing)≥1.5×107/kg、tubule recovery rate≥80%;

• patients and their family members or guardians agreed to the study and signed informed consent;

• No severe organ failure;

• ECOG score≤2 and HCT-CI≤2;

• serum ferritin (SF)\<1000ug/L;

• women of reproductive agemust have a negative pregnancy test and agree to use effective contraception during treatment and for one year thereafter.

Locations
Other Locations
China
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
RECRUITING
Hefei
Contact Information
Primary
Xiaoyu Zhu, ph.D
xiaoyuz@ustc.edu.cn
15255456091
Backup
Baolin Tang, M.D
zwcrystalbl@163.com
13856901277
Time Frame
Start Date: 2023-10
Estimated Completion Date: 2025-05-31
Participants
Target number of participants: 72
Treatments
ATG group
Patients in the ATG group will be treated with conditioning regimen containing ATG 2mg/kg on day -7 prior to transplant.
Related Therapeutic Areas
Sponsors
Leads: Anhui Provincial Hospital

This content was sourced from clinicaltrials.gov

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