Interferon-α for Preventing Relapse in TP53+ Myeloid Malignancy Post Allo-HSCT

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Deparment of Hematology, Peking University People's Hospital
RECRUITING
Beijing
Contact Information
Primary
Yu Wang
ywyw3172@sina.com
86-13552647384
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 35
Treatments
Experimental: IFN-α application in TP53+ myeloid malignancy
Sponsors
Leads: Peking University People's Hospital

This content was sourced from clinicaltrials.gov

Similar Clinical Trials