Interferon-α for TP53 Myeloid Malignancy Post Allo-HSCT

Sponsor

Peking University People's Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06130579

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Myeloid Leukemia Myelodysplastic Syndromes	Drug: IFN-Α	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

35 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Jun 30, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

The incidence of relapse [1 year post HSCT]
Disease relapse was defined as blasts ≥ 5% post transplantation.

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Peking University People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xiao-Jun Huang, Professor, Peking University People's Hospital

ClinicalTrials.gov Identifier:

NCT06130579

Other Study ID Numbers:

IFN-α for preventing relapse

First Posted:

Nov 14, 2023

Last Update Posted:

Nov 18, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Xiao-Jun Huang, Professor, Peking University People's Hospital

IFN-α

Preventing relapse

allo-HSCT

Additional relevant MeSH terms:

Myelodysplastic Syndromes

Study Results

No Results Posted as of Nov 18, 2023