Dual Growth Factor (rhTPO + G-CSF) and Chemotherapy Combination Regimen for Elderly Patients With Acute Myeloid Leukemia: A Phase II Single-Arm Multicenter Study
연구 개요
상세 설명
Acute myeloid leukemia (AML) is one of the most common hematologic malignancies and affects older adults. The median age at diagnosis is 67 years. As the elderly increasingly account for a greater population percentage, AML is becoming more problematic. During the past 30 years, outcomes have improved for younger patients, whereas the prospects for older adults (> 60 years) have remained poor. The response rate in older adults given standard induction regimens is < 50%, and median overall survival (OS) is < 1 year. Older adults elderly are also inordinately burdened by unfavorable cytogenetic defects, medical comorbidities, and reduced tolerability to intensive chemotherapeutic protocols. These vulnerabilities predispose older adults to poorer outcomes than their younger counterparts, conferring lower response rates and shortened survival times (progression-free and overall survival [OS]). Safe and effective treatments for elderly patients with AML are thus urgently needed.
In 2000, Saito et al introduced a regimen of granulocyte colony-stimulating factor (G-CSF) plus low-dose cytarabine (ara-C) and aclarubicin (ACR) for use in this setting (CAG regimen), in an attempt to incorporate a hematologic growth factor in AML induction therapy, rather than relying on supportive care. The addition of decitabine, a demethylation agent, further improved the prognosis, yielding a 10-month median OS. This successful use of G-CSF in an induction regimen for AML confirmed its utility, helping to increase efficacy and reduce side effects in elderly patients.
Thrombopoietin (TPO) is a major factor in regulating megakaryocytic proliferation, maturation, and platelet formation. Recombinant human TPO (rhTPO) has been approved by China's State Food and Drug Administration to treat thrombocytopenia after chemotherapy. TPO and c-MPL receptors are also involved in various physiologic processes, such as mitigating myocardial injury, nerve repair, vascular regeneration, sex hormone secretion, and immune regulation. However, the role of rhTPO in an induction regimen for AML is unreported as yet.
To determine if adding rhTPO to D-CAG (G-CSF) will increase the overall response rate (ORR) while decreasing the side effect of toxic agents, we designed a regimen of rhTPO and G-CSF in combination with decitabine, cytarabine, and aclarubicin (D-CTAG regimen). This trial aimed to determine the safety and efficacy of this D-CTAG regimen as a treatment for older adult patients with newly diagnosed AML.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Huihan Wang, Doctor
- 전화번호: +86 18940256966
- 이메일: wanghh24115@outlook.com
연구 장소
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Liaoning
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Shenyang, Liaoning, 중국, 110004
- 모병
- Shengjing Hospital of China Medical University
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연락하다:
- Huihan Wang, Doctor
- 전화번호: +86 18940256966
- 이메일: wanghh24115@outlook.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Inclusion Criteria:
- Age 60 or above, male or female;
- Acute Myeloid Leukemia (non-M3) diagnosed according to the 2008 World Health Organization (WHO) diagnostic criteria for myeloid malignancies;
- Newly diagnosed, no treatment for anti-leukemia;
- The Eastern Cooperative Oncology Group（ECOG） status score is 0 to 3 points;
- Expected survival time ≥ 3 months;
- No serious heart, lung, liver or kidney disease;
- History of no thromboembolism
- Ability to understand and be willing to sign the informed consent form of this trial.
Exclusion Criteria:
Exclusion Criteria:
- used to be allergic to the drugs contained in the protocol or to drugs similar in chemical structure to the test drugs;
- serious active infections;
- Patients with extramedullary lesions;
- Patients who use drugs and long-term alcohol abuse to influence the evaluation of test results;
- Inability to obtain informed consent and cannot complete the trial treatment and examination procedures because of mental illness or other conditions
- Patients with clinically significant corrected QT interval (QTc) prolongation (male > 450ms, female > 470ms), Ventricular Tachycardia (VT), Atrial Fibrillation (AF), grade II or higher heart block, Myocardial Infarction (MI) within 1 year, Congestive Heart Failure (CHF), coronary heart disease with symptoms who need medical treatment;
- Abnormal liver function (total bilirubin > 1.5 times the upper limit of normal value, Alanine aminotransferase(ALT) / Aspartate aminotransferase (AST) >2.5 times the upper limit of normal value or ALT / AST in patients with liver invasion > 5 times the upper limit of normal value of normal), abnormal renal function (serum Creatinine > 1.5 times the upper limit of normal);
- The investigator determine that the participants are not suitable
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: lderly Patients With Acute Myeloid Leukemia
decitabine (15 mg/m2 daily, days 1-5); low-dose cytarabine (10 mg/m2 q12 h, days 3-9); rhTPO (15,000 U daily, days 2, 4, 6, 8, and 10-24 or until a platelet count > 50 × 109/L was observed); aclarubicin (14 mg/m2 daily, days 3-6); and G-CSF (300 μg daily, days 2-9).
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데시타빈(매일 15mg/m2, 1-5일); 저용량 시타라빈(10mg/m2 q12h, 3-9일); rhTPO(매일 15,000U, 2일, 4일, 6일, 8일 및 10-24일 또는 혈소판 수가 > 50 × 109/L가 관찰될 때까지); 아클라루비신(매일 14mg/m2, 3-6일); 및 G-CSF(매일 300㎍, 2-9일).
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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overall survival (OS)
기간: 2 years after the end of treatment of the last patient enrolled
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overall survival ]
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2 years after the end of treatment of the last patient enrolled
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Huihan Wang, Doctor, Shengjing Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
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추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- WangHH
개별 참가자 데이터(IPD) 계획
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