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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Fase 2
Contacten en locaties
Studiecontact
- Naam: Yuanjie Ding
- Telefoonnummer: 010-88325948
- E-mail: rmkyc@163.com
Studie Contact Back-up
- Naam: Fei-fei Tang
- Telefoonnummer: 86-13521893860
- E-mail: bjmugirl@163.com
Studie Locaties
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Beijing, China
- Werving
- Peking University People's Hospital
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Contact:
- Fei-fei Tang
- Telefoonnummer: 86-13581671687
- E-mail: bjmugirl@163.com
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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. -
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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2-Year Cumulative Incidence of Relapse
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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2-Year Event-Free Survival (EFS)
Tijdsspanne: 2 years after enrollment
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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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
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Medewerkers en onderzoekers
Onderzoekers
- Studie stoel: Xiangyu Zhao, Peking University People's Hospital
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IFN-α in AML Maintenance
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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