Interferon-α for TP53 Myeloid Malignancy Post Allo-HSCT

NCT06130579 | Recruiting Phase 2

• 1 other identifier: IFN-α for preventing relapse
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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).

Conditions

Myeloid Leukemia; Myelodysplastic Syndromes

Keywords

IFN-α; Preventing relapse; allo-HSCT

Outcome Measures

Primary Outcomes (1)

• The incidence of relapse

  Disease relapse was defined as blasts ≥ 5% post transplantation.

  1 year post HSCT

Secondary Outcomes (5)

• The incidence of positive minimal residual disease post allo-HSCT

  1 year post HSCT

• The incidence of acute and chronic graft versus host disease (GvHD)

  aGvHD within 100 days and cCvHD within 1 year

• The incidence of non-relapse mortality

  1 year post HSCT.

• The probability of progression free survival

  1 year post HSCT.

• The probability of overall survival (OS)

  1 year post HSCT.

Study Arms (1)

IFN-α application in TP53+ myeloid malignancy

EXPERIMENTAL

Drug: IFN-Α

Interventions

IFN-Α DRUG

Leukemia-associated immunophenotyping (LAIPs) was performed by flow cytometry at +1 month and +2 month after HSCT. If MRD was negative on two consecutive flow cytometry assays, interferon-α prophylaxis was initiated on day +75 after transplantation, and cyclosporine was tapered on day +100 after transplantation. The dose of interferon-α was 3 million units/time, subcutaneously injected twice a week. Cycles were given every 4 weeks until hematologic relapse or up to 6 cycles.

IFN-α application in TP53+ myeloid malignancy

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• patients who are unable to complete the necessary treatment plan and follow-up observation
• patients with severe acute anaphylaxis
• clinically uncontrolled severe life-threatening infections
• patients enrolled in other clinical trials
• other reasons considered by the investigator to be inappropriate for clinical trial participants.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Deparment of Hematology, Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid; Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

Central Study Contacts

Yu Wang

CONTACT

86-13552647384; ywyw3172@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 14, 2023
• Study Start: January 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)