NCT06378060 Clinical Study on Modified Allogeneic Hematopoietic Stem Cell Transplantation Regimen for Severe Aplastic Anemia
| NCT ID | NCT06378060 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Hematology department of the 920th hospital |
| Condition | Severe Aplastic Anemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2026-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2024-03-01 with a primary completion date of 2026-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of this study was to evaluate the safety and efficacy of a modified allogeneic hematopoietic stem cell transplantation regimen for aplastic anemia.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06378060 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 65 Years, studying Severe Aplastic Anemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06378060 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06378060 currently recruiting?
Yes, NCT06378060 is actively recruiting participants. Contact the research team at Wangsanbin2022@126.com for enrollment information.
Where is the NCT06378060 trial being conducted?
This trial is being conducted at Kunming, China.
Who is sponsoring the NCT06378060 clinical trial?
NCT06378060 is sponsored by Hematology department of the 920th hospital. The trial plans to enroll 30 participants.