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임상시험 NCT06742515은(는) Precursor B-Cell Acute Lymphoblastic Leukemia에 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
Blinatumomab Plus Reduced-dose Chemotherapy in Treating B-ALL 2상 20 면역 요법
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 NCT06742515은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 Precursor B-Cell Acute Lymphoblastic Leukemia에 대해 진행되며, 2상 중재연구으로 현재 상태는 모집중입니다. 연구는 2024년 10월 17일에 시작되어 20명의 참여자를 모집하고 있습니다. First Affiliated Hospital of Zhejiang University이(가) 진행하며, 2028년 8월 31일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2024년 12월 19일에 갱신되었습니다.
간단한 개요
Precursor B cell acute lymphoblastic leukemia (B-ALL) is an aggressive type of leukemia, with high relapse rate and poor long term survival in adults. Traditional treatment regimens mainly include chemotherapy and hematopoietic stem cell transplantation. In the past decade, with the application of molecular targeted drugs and immunotherapy, the survival of B-ALL patients has significantly improved. In this study，we p...더 보기
상세한 설명
This is a prospective, single-arm, phase II and open-label study. A total of 20 Ph-negative B-ALL participants will be enrolled. The primary endpoint is MRD-negative CR rate. The induction therapy is a combination of Blinatumomab(Blina), Vindesine(VDS), Cyclophosphamide(CTX) and Dexamethasone(DXM). The second cycle would be the combination of Blina and Venetoclax(VEN). As for consolidation therapy, we suggest the bon...더 보기
공식 제목
Blinatumomab Combined With Reduced-dose Chemotherapy in Treating Precursor B Cell Acute Lymphoblastic Leukemia: a Phase II, Single Arm and Multicenter Study
질환명
Precursor B-Cell Acute Lymphoblastic Leukemia출판물
이 임상시험에 대해 발표된 과학 논문 및 연구 자료.기타 연구 식별자
- IIT20240126C
NCT 번호
실제 연구 시작일
2024-10-17
최신 업데이트 게시
2024-12-19
예상 연구 완료일
2028-08-31
계획된 등록 인원
20
연구종류
중재연구
단계/상
2상
상태
모집중
키워드
Acute Lymphoblastic Leukemia
Chemotherapy
Immunotherapy
Chemotherapy
Immunotherapy
주요 목적
치료
설계 할당
해당 없음
중재 모델
단일군설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Treatment arm Blinatumomab plus Reduced-dose Chemotherapy | Blinatumomab plus Reduced-dose Chemotherapy Cycle 1: Reduced VCP on day1, IV and Blinatumomab for 2 weeks, IV. Cycle 2: Blinatumomab for 2 weeks, IV and Venetoclax for 2 weeks, oral. |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Complete remission rate with negative minimal residual disease | complete remission and negative MRD detected by flowcytometry | at the end of cycle 1 and 2（each cycle is 28 days） |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
CR/CRi after Cycle 1 and 2 | Blast rate lower than 5% with or without peripheral blood cell recovery | at the end of cycle 1 and 2（each cycle is 28 days） |
Minimal residual disease(MRD) | MRD level detected by flow cytometry which value \<0.1% is defined as negtive | At the end of each cycle（each cycle is 28 days） |
Overall survival (OS) | Defined for all patients in a trial; measured from day 1 of treatment to the date of death from any cause; | up to 5 years |
Event free survival(EFS) | Defined for all patients in a trial; measured from day 1 of treatment to the date of treatment failure, hematologic relapse from CR/CRi or death from any cause, whichever occurs first; | up to 5 years |
참여 도우미
적격성 기준
연령대
어린이, 성인
최소 연령
15 Years
참여 가능한 성별
전체
- 1. Before enrollment, patients must be diagnosed with de novo precursor B-cell acute lymphoblastic leukemia and be negative for Philadelphia chromosome. The diagnostic criteria refer to the 2022 WHO classification; 2. Age≥15 years， ≤59 years; 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; 4. Expected survival time ≥ 2 months; 5. No organ dysfunction that would restrict the use of this protocol during the screening period; 6. Understand the study and sign the informed consent form. 7. Men, women of childbearing age (only postmenopausal women who have been menopausal for at least 12 months can be considered infertile), and their partners voluntarily take effective contraceptive measures deemed effective by the investigator during the treatment period and for at least 12 months after the last dose of the study drug.
- 1. Patients with known central nervous system (CNS) involvement of ALL; 2. Diseases with abnormal heart, lung, liver, kidney, or other organ functions that may limit the patient's participation in this trial (including but not limited to severe infections, uncontrolled diabetes, severe heart failure or angina, active pulmonary tuberculosis, asthma, COPD, bronchiectasis, etc.); 3. Cardiac ultrasound LVEF < 45%; 4. History of other malignancies within the past 5 years, excluding localized thyroid cancer and in situ skin cancer; 5. Serum total bilirubin > 1.5 ULN (upper limit of normal); ALT or AST > 2.5 ULN; serum creatinine > 1.5 ULN; 6. Known HIV infection; 7. Conditions affecting the use of the study drug as assessed by the investigator; 8. Unable to understand or comply with the study protocol.
First Affiliated Hospital of Zhejiang University연구 대표 연락처
연락처: Jie Jin, M.D., +8657187236896, [email protected]
연락처: Chenying Li, Ph.D., +8657187236896, [email protected]
1 1개국에 임상시험 장소
Zhejiang
The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310003, Hangzhou, Zhejiang, 310003, China
Jie Jin, M.D., 연락처, +86571-87236896, [email protected]
모집중