A Phase 2 Study of MAX-40279 Combined With Venetoclax and Azacitidine in Unfit Newly Diagnosed Acute Myeloid Leukemia
연구 개요
상세 설명
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Jing Wang
- 전화번호: 8621-61009600
- 이메일: jwang@maxinovel.com
연구 장소
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Tianjin, 중국
- 모병
- Institute of Institute of Hematology & Blood Diseases Hospital ( Chinese Academy of Medical Sciences)
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연락하다:
- jianxiang Wang, MD
- 전화번호: 86-22-23909278
- 이메일: wangjx@ihcams.ac.cn
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
1. Patients meeting the World Health Organization (WHO) 2016 diagnostic criteria for newly diagnosed acute myeloid leukemia (AML) patients unfit for intensive chemotherapy:
- Age ≥65 years, or
- Age >18 years and ineligible for standard-dose chemotherapy, defined by ≥1 of the following:
ECOG performance status 2 or 3；History of chronic heart failure (CHF) requiring treatment or left ventricular ejection fraction (LVEF) ≤50% DLCO ≤65% or FEV1 ≤65%Creatinine clearance ≥30 mL/min but ≤45 mL/min (Cockcroft-Gault)、Any other condition deemed incompatible with standard chemotherapy (requires PI approval) 2. No prior AML therapy, except:Hydroxyurea. 3. ECOG performance status ≤3 4. Laboratory requirements: WBC≤3×10*9/L、AST/ALT/ALP ≤3×ULN (except: due to leukemic involvement)、Total bilirubin ≤1.5×ULN、Serum creatinine clearance ≥30 mL/min (measured or calculated) 5. Life expectancy ≥3 months 6. Contraception requirements: Negative pregnancy test for women of childbearing potential；Agreement to use effective contraception during treatment and for 6 months after therapy
Exclusion Criteria:
- AML with BCR::ABL1 fusion、Acute promyelocytic leukemia (APL).
- Secondary AML, including:Therapy-related AML (per WHO classification)、AML with prior history of myelodysplastic syndrome (MDS) or myeloproliferative neoplasm (MPN).
- Use of strong/moderate CYP3A4 inducers within 3 days prior to treatment initiation.
- Hypersensitivity to any study drugs.
- Active malignancy in other organs (requiring treatment).
- Active cardiac disease, defined as ≥1 of the following:Myocardial infarction within 6 months before enrollment；History of symptomatic arrhythmia requiring medication；Uncontrolled/symptomatic congestive heart failure (NYHA Class >2)
- Active infections, including:Untreated tuberculosis or any aspergillosis.
- Known HIV, active hepatitis B (HBV), or hepatitis C (HCV).
- Central nervous system (CNS) leukemia at baseline.
- Conditions limiting oral drug absorption (e.g., malabsorption syndrome).
- Medical history of:Epilepsy requiring medication、Dementia or psychiatric disorders impairing protocol compliance.
- Investigator's discretion for ineligibility.
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: MAX-40279 Combined with Venetoclax and Azacitidine in unfit newly diagnosed AML
Patients in dose escalation stage received oral MAX-40279 at 40 mg, 50 mg, and 60 mg twice daily (BID), in combination with VEN (100 mg on day 1, 200 mg on day 2, and 400 mg daily thereafter) and AZA (75 mg/m2 days 1-7) in 28-day cycles. Patients in dose expansion stage received RP2D MAX-40279 plus VEN (100 mg on day 1, 200 mg on day 2, and 400 mg daily thereafter) and AZA (75 mg/m2 days 1-7). |
Dose escalation：MAX-40279: 40 mg, 50 mg, and 60 mg twice daily (BID). Dose expantion: MAX-40279 RP2D. Venetoclax: 100 mg on day 1, 200 mg on day 2, and 400 mg daily thereafter. Azacitidine: 75 mg/m2 days 1-7. 28 days are one cycle.
Given by IV, 75 mg/m2
다른 이름들:
100 mg on day 1, 200 mg on day 2, and 400 mg daily thereafter.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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DLT
기간: Dose escalation; an average of 6 months.
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The dose limiting toxicities, Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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Dose escalation; an average of 6 months.
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Adverse events (AEs), serious adverse events (SAEs)
기간: Through study completion; an average of 24 months.
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Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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Through study completion; an average of 24 months.
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Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose (RP2D)
기간: Dose escalation; an average of 6 months.
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Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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Dose escalation; an average of 6 months.
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CRc
기간: Through study completion; an average of 24 months.
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complete remission rate
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Through study completion; an average of 24 months.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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RFS
기간: Through study completion; an average of 8 months.
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Recurrence-Free Survival
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Through study completion; an average of 8 months.
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DoR
기간: Through study completion; an average of 8 months.
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duration of response
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Through study completion; an average of 8 months.
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OS
기간: Through study completion; an average of 24 months.
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overall survival
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Through study completion; an average of 24 months.
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jianxiang Wang, MD, Institute of Institute of Hematology & Blood Diseases 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
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- MAX-40279-010
- CTR20250827 (레지스트리 식별자: CENTER FOR DRUG EVALUATION, NMPA)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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