Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 3 to 65

Modified stem cell transplantation for severe aplastic anemia

Official title: A Prospective, Multi-center, Single-arm Clinical Study to Evaluate the Safety and Efficacy of a Modified Allogeneic Hematopoietic Stem Cell Transplantation Regimen for Severe Aplastic Anemia

Run by Hematology department of the 920th hospital · NCT06378060 · Data updated 2026-11-12

This study is testing a new way of doing stem cell transplants for people with severe aplastic anemia to see if it can help them live longer and reduce complications.

Quick facts

PhasePhase 2
Study typeInterventional
Ages3 Years to 65 Years
SexAll
Enrollment30 (estimated)
SponsorHematology department of the 920th hospital
Academic / other
Locations1 site (Kunming, Yunnan)
StatusRecruiting
StartedMarch 1, 2024
Main results expectedApril 1, 2026
Study endsApril 1, 2027
Registry record updatedApril 22, 2024
Trial IDNCT06378060 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are patients aged 3-65 years with severe aplastic anemia or other hematological diseases requiring allogeneic stem cell transplantation.

Probably not a fit

Patients with non-hematologic diseases or those with an expected survival of less than one month may not benefit from this study.

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

What this trial studies

This clinical study evaluates the safety and efficacy of a modified allogeneic hematopoietic stem cell transplantation regimen specifically for patients with severe aplastic anemia. The study aims to enhance the success rate of the transplantation process by improving the conditioning regimen and optimizing measures to prevent graft-versus-host disease (GVHD). A total of 30 patients aged 3 to 65 years with various hematological diseases will be enrolled to assess the outcomes of this modified approach. The goal is to prolong patient survival while minimizing complications associated with the procedure.

Why it matters

Potential benefit: If successful, this study could significantly improve survival rates and quality of life for patients with severe aplastic anemia.

How similar studies have gone: Other studies have shown promising results with modified transplantation regimens, indicating potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Patients with benign or malignant hematological diseases such as leukemia, lymphoma, thalassemia, aplastic anemia, etc. diagnosed by NCCN guidelines, and requiring allogeneic hematopoietic stem cell transplantation as determined by the researchers;
2. Age 3-65 years old;
3. Weight 10Kg-100Kg;
4. Eastern Cooperative Oncology Group (ECOG) score ≤3;
5. No major organ injury (ECG ejection fraction \>45%; bilirubin \< 2 times the upper limit of normal value; AST and ALT \< 3 times the upper limit of normal value; serum creatinine \< 2 times the upper limit of normal value);
6. No severe infection;
7. Subjects voluntarily participated in this clinical trial and signed the informed consent.

Exclusion Criteria:

1. patients with nonhematologic diseases who are not eligible for transplantation or who do not wish to receive transplantation;
2. patients with an expected survival of less than 1 month;
3. patients with previous autologous or allogeneic hematopoietic stem cell transplantation;
4. pregnant patients;
5. patients with severe mental or neurological disorders that would affect the ability to provide informed consent and/or to report or observe adverse events;
6. other conditions that the investigator determines to be inappropriate for enrollment.

Where it's running

  • 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
    Kunming, Yunnan, China
    Recruiting

Study contacts

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

  • Bone marrow transplant for severe aplastic anemia

    This study is testing if bone marrow transplants from partially matched or unrelated donors can help people aged 3 to 75 with severe aplastic anemia who haven't had treatment before.

    Recruiting at 25 sites Phase 2 Medical College of Wisconsin · Birmingham, Alabama and 24 other locations · NCT06517641

  • Hematopoietic cell transplant for severe blood disorders

    This study is testing a new way to prepare patients with severe blood disorders for a stem cell transplant to see if it can improve their recovery and reduce complications.

    Recruiting Phase 2 Masonic Cancer Center, University of Minnesota · Minneapolis, Minnesota · NCT06412497

  • Using Rituximab to treat severe aplastic anemia with platelet transfusion issues

    This study is testing if rituximab can help people with severe aplastic anemia who have trouble getting enough platelets from transfusions.

    Recruiting Phase 2 Institute of Hematology & Blood Diseases Hospital, China · Tianjin, Tianjin Municipality · NCT06254560

  • Understanding long-term effects of bone marrow failure syndromes

    This study is looking at how bone marrow failure syndromes affect people over time to see how the disease and treatments change, focusing on individuals aged 2 and older.

    Recruiting National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT05012111

  • Haploidentical stem cell transplant for treating blood disorders in children

    This study is testing a new way to use stem cell transplants from partially matched family members to help children with serious blood disorders feel better when other treatments haven't worked.

    Recruiting Phase 2 Johns Hopkins All Children's Hospital · St. Petersburg, Florida · NCT04356469

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.