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Trial Title:
Interferon-α for TP53 Myeloid Malignancy Post Allo-HSCT
NCT ID:
NCT06130579
Condition:
Myeloid Leukemia
Myelodysplastic Syndromes
Conditions: Official terms:
Myelodysplastic Syndromes
Conditions: Keywords:
IFN-α
Preventing relapse
allo-HSCT
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
IFN-Α
Description:
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 group label:
IFN-α application in TP53+ myeloid malignancy
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).
Criteria for 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.
Gender:
All
Minimum age:
12 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Deparment of Hematology, Peking University People's Hospital
Address:
City:
Beijing
Zip:
100044
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaojun Huang, doctor
Phone:
8601088326666
Email:
xjrm@medmail.com.cn
Start date:
January 1, 2024
Completion date:
June 30, 2025
Lead sponsor:
Agency:
Peking University People's Hospital
Agency class:
Other
Source:
Peking University People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06130579
