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.
연구 개요
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Yuanjie Ding
- 전화번호: 010-88325948
- 이메일: rmkyc@163.com
연구 연락처 백업
- 이름: Fei-fei Tang
- 전화번호: 86-13521893860
- 이메일: bjmugirl@163.com
연구 장소
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Beijing, 중국
- 모병
- Peking University People's Hospital
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연락하다:
- Fei-fei Tang
- 전화번호: 86-13581671687
- 이메일: bjmugirl@163.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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. -
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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2-Year Cumulative Incidence of Relapse
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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2-Year Event-Free Survival (EFS)
기간: 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)
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 연구 의자: Xiangyu Zhao, Peking University People's Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- IFN-α in AML Maintenance
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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