NCT06130579 Interferon-α for TP53 Myeloid Malignancy Post Allo-HSCT
| NCT ID | NCT06130579 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Peking University People's Hospital |
| Condition | Myeloid Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2025-12-31 |
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 35 participants in total. It began in 2024-01-01 with a primary completion date of 2025-12-31.
⚠ 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
To investigate the efficacy of interferon-α prophylaxis in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) with TP53 mutation who were negative for minimal residual disease (MRD) by flow cytometry within 2 months after allogeneic hematopoietic stem cell transplantation. To explore the efficacy of interferon-α in reducing the relapse rate of AML/MDS patients with TP53 mutation after allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Eligibility Criteria
Inclusion Criteria: 1. Myelodysplastic syndrome (MDS) diagnosed according to the 2022 International Consensus Classification of Myeloid Neoplasms and Acute Leukemia (2022ICC) criteria, acute myeloid leukemia (AML) with TP53 mutation (unrestricted remission status), minimal residual disease (MRD) monitored by flow cytometry within 2 months after receiving the first allogeneic hematopoietic stem cell transplantation Negative patients 2. Male or female, aged 12-65 years 3. Karnofsky score \>60, estimated survival time \>3 months 4. No history of severe graft-versus-host disease (GVHD), uncontrolled GVHD, or severe systemic organ dysfunction: 1. Absolute neutrophil count (ANC) greater than 0.5×109/L 2. Creatinine \< 1.5mg/dL 3. Cardiac ejection index \>55% 5. Signed informed consent. Exclusion Criteria: 1. severe cardiac, renal, or liver dysfunction 2. combined with other malignant tumors requiring treatment 3. inability to understand or adhere to the study protocol due to clinical symptoms of brain dysfunction or severe mental illness 4. patients who are unable to complete the necessary treatment plan and follow-up observation 5. patients with severe acute anaphylaxis 6. clinically uncontrolled severe life-threatening infections 7. patients enrolled in other clinical trials 8. other reasons considered by the investigator to be inappropriate for clinical trial participants.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06130579 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 65 Years, studying Myeloid Leukemia. 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 NCT06130579 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 NCT06130579 currently recruiting?
Yes, NCT06130579 is actively recruiting participants. Contact the research team at ywyw3172@sina.com for enrollment information.
Where is the NCT06130579 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06130579 clinical trial?
NCT06130579 is sponsored by Peking University People's Hospital. The trial plans to enroll 35 participants.
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