NCT06130579RecruitingPhase 2
Interferon-α for TP53 Myeloid Malignancy Post Allo-HSCT
Interferon-α for Preventing Relapse in TP53+ Myeloid Malignancy Post Allo-HSCT
Source: ClinicalTrials.gov · Last updated 3 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 35 (estimated)
- First submitted
- 8 Nov 2023
- Start date
- 1 Jan 2024
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Peking University People's Hospital
- NCT number
- NCT06130579
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 35
- From 1 Jan 2024 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- severe cardiac, renal, or liver dysfunction
- combined with other malignant tumors requiring treatment
- inability to understand or adhere to the study protocol due to clinical symptoms of brain dysfunction or severe mental illness
- clinically uncontrolled severe life-threatening infections
Other
- patients who are unable to complete the necessary treatment plan and follow-up observation
- patients with severe acute anaphylaxis
- patients enrolled in other clinical trials
- other reasons considered by the investigator to be inappropriate for clinical trial participants.
Who the study is looking for
- 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
- Male or female, aged 12-65 years
- Karnofsky score \>60, estimated survival time \>3 months
- No history of severe graft-versus-host disease (GVHD), uncontrolled GVHD, or severe systemic organ dysfunction:
- Absolute neutrophil count (ANC) greater than 0.5×109/L
- Creatinine \< 1.5mg/dL
- Cardiac ejection index \>55%
- Signed informed consent.
Age in the registry: 12 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Deparment of Hematology, Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.