임상 레이더 AI | ||
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임상시험 NCT06361329은(는) ETP-ALL에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
Comparing the Efficacy of VHAG and Traditional Chemotherapy Regimens in Newly Diagnosed ETP-ALL 3상 81
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT06361329은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 ETP-ALL에 대해 진행되며, 3상 중재연구으로 현재 상태는 모집중입니다. 연구는 2024년 4월 3일에 시작되어 81명의 참여자를 모집하고 있습니다. First Affiliated Hospital of Zhejiang University이(가) 진행하며, 2027년 3월 31일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 2월 17일에 갱신되었습니다.
간단한 개요
ETP-ALL is a subtype of T-cell acute lymphoblastic leukemia (T-ALL) with poor outcomes and prognosis. Effective induction therapy is crucial in improving the treatment effect. Based on our laboratory research and clinical practice, the venetoclax plus HAG regimen shows promising efficacy in treating ETP-ALL. Therefore, we plan to conduct a prospective, multicenter Phase III clinical study to evaluate the efficacy of ...더 보기
공식 제목
A Multicenter, Prospective, Randomized Controlled Clinical Study Comparing the Efficacy of VHAG and Traditional Chemotherapy Regimens in the Treatment of Adult Newly Diagnosed Early Precursor T-cell Acute Lymphoblastic Leukemia (ETP-ALL)
질환명
ETP-ALL기타 연구 식별자
- 20240030C
NCT 번호
실제 연구 시작일
2024-04-03
최신 업데이트 게시
2025-02-17
예상 연구 완료일
2027-03-31
계획된 등록 인원
81
연구종류
중재연구
단계/상
3상
상태
모집중
주요 목적
치료
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적VHAG group Venetoclax: 100mg on day 1, 200mg on day 2, and 400mg on days 3-14, if the blast cells in bone marrow were more than 5% on day 14, the patient continued to receive venetoclax 400mg until day 28.
HHT:1.4 mg/m2,2mg maximum daily, intravenously daily from on d1-7 Cytarabine :10 mg/m2 subcutaneously every 12h on d1-14（d10-d14） G-CSF: 100ug/m2 daily on d1-14 if WBC count \<10\*10E9/L | Homoharringtonine Intravenous infusion venetoclax Orally by mouth Cytarabine subcutaneous injection or Intravenous infusion G-CSF subcutaneous injection |
활성 대조군Traditional Chemotherapy Regimen group * VDCLP regimen
* VD(/I) CP regimen
* Hyper CVAD-A regimen
* VDLP regimen | Cytarabine subcutaneous injection or Intravenous infusion Vindesine Intravenous infusion Daunorubicin Intravenous infusion cyclophosphamide Intravenous infusion Dexamethasone Intravenous infusion or orally L-ASP subcutaneous injection |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
1-year EFS | 1-year event free survival rate | 1 year |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
CR/CRi | Complete remission/complete remission with incomplete count recovery | At the end of Cycle 1 (up to 42 days) |
OS | Overall survival | through study completion, up to 3 years |
MRD | Percentage of participants who converted to MRD \< 10\^-3 after the first cycle of treatment. | At the end of Cycle 1 (up to 42 days) |
Safety of induction therapy | Adverse events | At the end of Cycle 1 (up to 42 days) |
참여 도우미
적격성 기준
연령대
어린이, 성인, 노인
최소 연령
14 Years
참여 가능한 성별
전체
- Age ≥14 and <75 years old.
- Diagnosed with ETP-ALL (including near-ETP ALL) before enrollment.
- Newly diagnosed patients.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Expected survival of ≥3 months.
- Able to undergo oral treatment with venetoclax.
- No organ dysfunction that would restrict the treatment administered
- Understanding of the study and signing of the informed consent form.
- Men, women of childbearing potential (postmenopausal women must have been amenorrheic for at least 12 months to be considered infertile), and their partners must voluntarily use effective contraception methods as deemed appropriate by the investigator during the treatment period and for at least 12 months after the last dose of the study drug.
- Patients who are unable to take venetoclax by mouth;
- Patients with severe heart, lung, liver, kidney, or other organ dysfunction that may restrict their participation in this trial due to diseases;
- Evidence of other clinically significant uncontrolled condition(s) such as uncontrolled and/or active systemic infection (viral, bacterial or fungal)
- A history of other malignant tumors within the past 5 years, excluding localized thyroid cancer and in situ skin cancer;
- Serum total bilirubin >1.5 ULN (upper limit of normal) (excluding leukemia infiltration); ALT or AST or ALP >5 ULN; serum creatinine >1.5 ULN and creatinine clearance rate <40 mL/min; LVEF <50%;
- Known HIV infection;
- Known central nervous system leukemia infiltration;
- Gastrointestinal diseases known to affect venetoclax absorption as judged by the investigator;
- Inability to understand or comply with the study protocol.
First Affiliated Hospital of Zhejiang University연락처 정보가 없습니다.
1 1개국에 임상시험 장소
Zhejiang
The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, 310003, China
Jie Jin, PhD&MD, 연락처, 13705716779, [email protected]
모집중