Testing the Addition of a New Anti-cancer Drug, Venetoclax, to the Usual Treatment (Ibrutinib and Obinutuzumab) in Untreated, Older Patients With Chronic Lymphocytic Leukemia
3상
진행 중(모집 완료)
NCT03737981
| 대상 질환 | Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma |
|---|
| 임상 단계 | 3상 |
|---|
| 스폰서 | National Cancer Institute (NCI) |
|---|
| 상태 | 진행 중(모집 완료) |
|---|
| 참여자 수 | 465 명 |
|---|
| 중재(약물) | Ibrutinib, Obinutuzumab, Observation Activity, Venetoclax |
|---|
| 시작일 | 2019년 1월 31일 |
|---|
| 완료일 | 2025년 1월 17일 |
|---|
| 결과 공개일 | 2026년 2월 2일 |
|---|
요약
This phase III trial compares adding a new anti-cancer drug (venetoclax) to the usual treatment (ibrutinib plus obinutuzumab) in older patients with chronic lymphocytic leukemia who have not received previous treatment. The addition of venetoclax to the usual treatment might prevent chronic lymphocytic leukemia from returning. This trial also will investigate whether patients who receive ibrutinib plus obinutuzumab plus venetoclax and have no detectable chronic lymphocytic leukemia after 1 year of treatment, can stop taking ibrutinib. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with obinutuzumab may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving ibrutinib and obinutuzumab with venetoclax may work better at treating chronic lymphocytic leukemia compared to ibrutinib and obinutuzumab.
Progression-free Survival (PFS)
5 years · proportion of participants w/out event
| Arm I (Ibrutinib, Obinutuzumab) | 0.59 proportion of participants w/out event |
|---|
| Arm II (Ibrutinib, Obinutuzumab, Venetoclax) | 0.68 proportion of participants w/out event |
|---|
| p-value | 0.2414 |
| Hazard Ratio (HR) | 0.89 (95% CI 0.64–1.24) |
BENITIONS에서 보기
ClinicalTrials.gov 원문 보기
같은 질환의 다른 임상
전체 임상
이 페이지는 ClinicalTrials.gov의 공개 데이터를 정리한 것입니다. 의학적 조언이 아니며 투자 권유나 자문도 아닙니다. 반드시 전문의와 상담하세요.