Interferon-α Maintenance in Favorable-Risk AML
Interferon-α as Maintenance Therapy for Favorable-Risk Acute Myeloid Leukemia: A Prospective, Single-Arm Study
Acute myeloid leukemia (AML) is a blood cancer with a substantial risk of relapse after initial treatment. Although patients with favorable-risk AML generally have better outcomes, relapse remains a major concern. Interferon-alpha (IFN-α) may help prevent relapse, but its effectiveness as maintenance therapy has not been confirmed in prospective studies.
This prospective, single-arm study aims to evaluate the efficacy and safety of IFN-α as maintenance therapy in patients with favorable-risk AML. Participants will receive IFN-α maintenance treatment and will be followed for disease relapse, survival, and treatment-related adverse events.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
Kontakter og lokationer
Studiekontakt
- Navn: Yuanjie Ding
- Telefonnummer: 010-88325948
- E-mail: rmkyc@163.com
Undersøgelse Kontakt Backup
- Navn: Fei-fei Tang
- Telefonnummer: 86-13521893860
- E-mail: bjmugirl@163.com
Studiesteder
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-
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Beijing, Kina
- Rekruttering
- Peking University People's Hospital
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Kontakt:
- Fei-fei Tang
- Telefonnummer: 86-13581671687
- E-mail: bjmugirl@163.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
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Age 18-70 years, inclusive.
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Newly diagnosed favorable-risk acute myeloid leukemia (AML) according to the 2022 European LeukemiaNet (ELN) risk classification.
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Achieved first complete remission (CR1) after 1-2 courses of standard chemotherapy.
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Completed 4-6 courses of consolidation chemotherapy, including at least 2 courses of high-dose cytarabine (HiDAC).
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Bone marrow examination at the end of consolidation therapy confirms continued CR1, with flow cytometric measurable residual disease (MRD) <0.1% and/or a >3-log reduction in molecular disease burden.
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Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
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Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal (ULN), and total bilirubin ≤2 times ULN, based on laboratory tests performed within 2 weeks before enrollment.
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Renal function: serum creatinine ≤1.5 times ULN, based on laboratory tests performed within 2 weeks before enrollment.
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Exclusion Criteria:
- Acute promyelocytic leukemia (APL).
- Patients who strongly prefer transplantation, or who have an indication for transplantation but are unable to undergo transplantation.
- Uncontrolled active infection.
- Severe organ failure.
- Pregnancy.
- Unwillingness to receive interferon therapy.
- History of hyperthyroidism or hypothyroidism.
- Participation in another clinical study within 1 month before enrollment. -
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Peginterferon Alfa-2b Maintenance Therapy
Eligible patients with favorable-risk acute myeloid leukemia (AML) in first complete remission (CR1) after consolidation chemotherapy will receive peginterferon alfa-2b injection at a dose of 135 μg once weekly by subcutaneous injection for 6 months. Participants will be monitored for disease relapse, measurable residual disease (MRD), survival, and treatment-related adverse events, with follow-up for 2 years after enrollment. |
Pegylated interferon alfa-2b injection, administered at a dose of 135 μg once weekly by subcutaneous injection for 6 months as maintenance therapy in patients with favorable-risk acute myeloid leukemia (AML) in first complete remission (CR1) after consolidation chemotherapy. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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2-Year Cumulative Incidence of Relapse
Tidsramme: 2 years after enrollment
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The proportion of patients who experience disease relapse within 2 years after enrollment. Relapse is defined as bone marrow blasts ≥5%, detection of leukemic cells in peripheral blood, or extramedullary leukemia. |
2 years after enrollment
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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2-Year Event-Free Survival (EFS)
Tidsramme: 2 years after enrollment
|
Event-free survival is defined as the time from enrollment to the first occurrence of molecular progression, hematologic relapse, or death from any cause. |
2 years after enrollment
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2-Year Overall Survival (OS)
Tidsramme: 2 years after enrollment
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Overall survival is defined as the time from enrollment to death from any cause. Participants who are alive at the last follow-up will be censored. |
2 years after enrollment
|
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MRD Conversion Rate Among Patients With MRD-Positive Disease at Enrollment
Tidsramme: Up to 2 years after enrollment
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The proportion of patients with measurable residual disease (MRD)-positive status at enrollment who achieve MRD-negative status during follow-up, assessed by multiparameter flow cytometry and/or quantitative PCR. |
Up to 2 years after enrollment
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Number of Participants With Grade 3 or Higher Adverse Events
Tidsramme: During the 6-month maintenance treatment period
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The number of participants experiencing grade 3 or higher adverse events during peginterferon alfa-2b maintenance therapy, including hematologic and hepatic toxicities. Adverse events will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. |
During the 6-month maintenance treatment period
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studiestol: Xiangyu Zhao, Peking University People's Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IFN-α in AML Maintenance
Plan for individuelle deltagerdata (IPD)
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