Interferon-α for TP53 Myeloid Malignancy Post Allo-HSCT

Myelodysplastic Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06130579
• Other study ID #: IFN-a for preventing relapse
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: March 2024
• Source: Peking University People's Hospital
• Contact: Yu Wang
• Phone: 86-13552647384
• Email: ywyw3172[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Myeloid Leukemia

Intervention

Drug:
• IFN-?
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-a prophylaxis was initiated on day +75 after transplantation, and cyclosporine was tapered on day +100 after transplantation. The dose of interferon-a was 3 million units/time, subcutaneously injected twice a week. Cycles were given every 4 weeks until hematologic relapse or up to 6 cycles.

Locations

Country	Name	City	State
China	Deparment of Hematology, Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of relapse	Disease relapse was defined as blasts = 5% post transplantation.	1 year post HSCT
Secondary	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
Secondary	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
Secondary	The incidence of non-relapse mortality	The incidence of non-relapse mortality	1 year post HSCT.
Secondary	The probability of progression free survival	Survival without disease progression	1 year post HSCT.
Secondary	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.