Interferon-α for TP53 Myeloid Malignancy Post Allo-HSCT
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-65
SponsorPeking University People's Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Absolute neutrophil count (ANC) greater than 0.5×109/L
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
IFN-Α
DrugLeukemia-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.
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: IFN-α application in TP53+ myeloid malignancyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The incidence of relapse
Disease relapse was defined as blasts ≥ 5% post transplantation.
Time frame
1 year post HSCTSecondary outcomes
1
The incidence of positive minimal residual disease post allo-HSCT
Positive MRD was defined as leukemia-associated immunophenotyping (LAIPs) by flow cytometry.
Time frame
1 year post HSCT2
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.
Time frame
aGvHD within 100 days and cCvHD within 1 year3
The incidence of non-relapse mortality
The incidence of non-relapse mortality
Time frame
1 year post HSCT.4
The probability of progression free survival
Survival without disease progression
Time frame
1 year post HSCT.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov