Haplo‑cord versus haplo hematopoietic stem cell transplant for aplastic anemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, open‑label multicenter study compares haplo‑cord hematopoietic stem cell transplantation with standard haploidentical transplantation in patients with aplastic anemia. Participants are adults and adolescents aged 14 years or older who are eligible for allogeneic transplantation and meet performance and comorbidity criteria. The trial measures safety and efficacy outcomes, with particular attention to graft failure, graft‑versus‑host disease, and other adverse events. Sites are located in Jiangsu province, China, and the protocol will collect factors associated with treatment outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria: (1)Aged ≥14 years. (2) Patients diagnosed with aplastic anemia meeting the diagnostic criteria of the Chinese Guidelines for the Diagnosis and Management of Aplastic Anemia (2024 Edition). (3) Patients who were eligible for allogeneic bone marrow or peripheral blood hematopoietic stem cell transplantation in accordance with the Clinical Application and Management Specifications for Allogeneic Hematopoietic Stem Cell Transplantation Technology (2022 Edition). (4) The patient understands the study protocol and voluntarily signs the informed consent form. (5) Life expectancy of ≥3 months; (6) Pre-transplant assessment meets the following criteria: Karnofsky Performance Status (KPS) score≥70, Eastern Cooperative Oncology Group Performance Status (ECOG PS) score≤2, and Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) score≤2.

Exclusion Criteria: (1)Patients with aplastic anemia secondary to malignancy treatment or those with concurrent active malignancy. (2) Women who are pregnant or lactating. (3) Patients with psychiatric or psychological disorders that preclude adequate compliance with the treatment protocol. (4) Patients with positive serologic testing for any of the four major infectious diseases (hepatitis B, hepatitis C, syphilis, HIV). (5) Patients with systemic infection or localized severe infection requiring active antimicrobial therapy. (6) Patients with significant dysfunction of major organs (e.g., heart, lung, liver, kidney). (7) Patients with a known allergy or hypersensitivity to any drug or component used in this study. (8) Patients who are currently participating in or plan to participate in any other clinical trial. (9) Any other condition deemed by the investigator to render the patient unsuitable for study participation.

Where it's running

• Hematology Department, The First Affiliated Hospital of Soochow University
  Suzhou, Jiangsu, China Recruiting
• Suzhou Hongci Hematology Hospital
  Suzhou, Jiangsu, China Recruiting
• The Affiliated Hospital of Xuzhou Medical University
  Xuzhou, Jiangsu, China Recruiting
• The First Affiliated Hospital of Zhejiang Chinese Medical University
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Xiaojin Wu
• Email: wuxiaojin@suda.edu.cn
• Phone: +8613057493105

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• BFCA conditioning for Haplo-HSCT in older adults with severe aplastic anemia

  This study tests the BFCA conditioning regimen in adults aged 40–60 with severe aplastic anemia undergoing haploidentical stem cell transplant to see if it’s safe and effective.

  Recruiting Peking University People's Hospital · Beijing, Beijing Municipality · NCT07586735

• Adverse effects of ATG/ALG treatment in aplastic anemia

  This project will see what side effects people with aplastic anemia experience when they receive ATG or ALG therapy.

  Recruiting Institute of Hematology & Blood Diseases Hospital, China · Tianjin · NCT07461116

• Sirolimus with or without cyclosporin A for Chinese adults with aplastic anemia who are refractory or intolerant to CsA

  This trial will test whether adding cyclosporin A to sirolimus helps Chinese adults with aplastic anemia who did not respond to or could not tolerate cyclosporin A.

  Recruiting Phase 2 Peking Union Medical College Hospital · Beijing, Beijing Municipality · NCT06802055

• Lower-dose immunosuppression plus hetrombopag for severe aplastic anemia in people 65 and older

  This study tests whether a lower-dose immunosuppressive regimen combined with hetrombopag can improve blood counts and safety for people aged 65 and older with severe or very severe aplastic anemia.

  Recruiting Phase 2 Institute of Hematology & Blood Diseases Hospital, China · Tianjin, Tianjin Municipality · NCT07010237

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.