BENITIONSClinical Trial Intelligence

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 질환Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
임상 단계3상
스폰서National Cancer Institute (NCI)
상태진행 중(모집 완료)
참여자 수465 명
중재(약물)Ibrutinib, Obinutuzumab, Observation Activity, Venetoclax
시작일2019년 1월 31일
완료일2025년 1월 17일
결과 공개일2026년 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-value0.2414
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.