Interferon-α for TP53 Myeloid Malignancy Post Allo-HSCT

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

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).

Study Overview

• Status: Recruiting
• Conditions: Myelodysplastic Syndromes; Myeloid Leukemia
• Intervention / Treatment: Drug: IFN-Α

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yu Wang; Phone Number: 86-13552647384; Email: ywyw3172@sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Recruiting
      • Deparment of Hematology, Peking University People's Hospital
      • Contact: Xiaojun Huang, doctor; Phone Number: 8601088326666; Email: xjrm@medmail.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: IFN-α application in TP53+ myeloid malignancy

Drug: IFN-Α; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of relapse	Disease relapse was defined as blasts ≥ 5% post transplantation.	1 year post HSCT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of non-relapse mortality	The incidence of non-relapse mortality	1 year post HSCT.
The incidence of positive minimal residual disease post allo-HSCT	Positive MRD was defined as leukemia-associated immunophenotyping (LAIPs) by flow cytometry.	1 year post HSCT
The incidence of acute and chronic graft versus host disease (GvHD)	The severity of acute GvHD (aGvHD) and chronic GvHD (cGvHD) was evaluated according to standard criteria.	aGvHD within 100 days and cCvHD within 1 year
The probability of progression free survival	Survival without disease progression	1 year post HSCT.
The probability of overall survival (OS)	OS was defined as the time from transplantation to death from any cause or to the last follow-up.	1 year post HSCT.

Collaborators and Investigators

• Sponsor: Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: November 8, 2023
• First Submitted That Met QC Criteria: November 8, 2023
• First Posted (Actual): November 14, 2023

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: allo-HSCT; IFN-α; Preventing relapse
• Additional Relevant MeSH Terms: Bone Marrow Diseases; Hematologic Diseases; Myelodysplastic Syndromes
• Other Study ID Numbers: IFN-α for preventing relapse

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No