Interferon-α for TP53 Myeloid Malignancy Post Allo-HSCT

Phase 2

Recruiting

• Conditions: Myeloid Leukemia; Myelodysplastic Syndromes
• Interventions: Drug: IFN-Α

• Registration Number: NCT06130579
• Lead Sponsor: Peking University People's Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-08
• Study First Submitted QC: 2023-11-08
• Study First Posted: 2023-11-14
• Study Start: 2024-01-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-21
• Primary Completion: 2024-12-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IFN-α application in TP53+ myeloid malignancy	IFN-Α	-

Primary Outcome Measures

Name	Time	Method
The incidence of relapse	1 year post HSCT	Disease relapse was defined as blasts ≥ 5% post transplantation.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Deparment of Hematology, Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China