Clinical trial NCT06130579: Interferon-α for TP53 Myeloid Malignancy Post Allo-HSCT
Official title: Interferon-α for Preventing Relapse in TP53+ Myeloid Malignancy Post Allo-HSCT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Myeloid Leukemia
Myelodysplastic Syndromes
Keywords: IFN-α
Preventing relapse
allo-HSCT
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2023-11-14
Enrollment: 35
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: The incidence of relapse
timeFrame: 1 year post HSCT
Secondary outcomes:
measure: The incidence of positive minimal residual disease post allo-HSCT
timeFrame: 1 year post HSCT
measure: The incidence of acute and chronic graft versus host disease (GvHD)
timeFrame: aGvHD within 100 days and cCvHD within 1 year
measure: The incidence of non-relapse mortality
timeFrame: 1 year post HSCT.
measure: The probability of progression free survival
timeFrame: 1 year post HSCT.
measure: The probability of overall survival (OS)
timeFrame: 1 year post HSCT.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Deparment of Hematology, Peking University People's Hospital
state: Beijing
Study officials:
References: