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

3期进行中（已停止招募） NCT03737981

适应症	Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
分期	3期
申办方	National Cancer Institute (NCI)
状态	进行中（已停止招募）
受试者人数	465 人
干预（药物）	Ibrutinib, Obinutuzumab, Observation Activity, Venetoclax
开始日期	2019年1月31日
完成日期	2025年1月17日
结果公布日	2026年2月2日

摘要

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)

在 BENITIONS 中查看查看 ClinicalTrials.gov 原文

同一适应症的其他试验

Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diag — National Cancer Institute (NCI)
Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Tr — National Cancer Institute (NCI)
Ibrutinib and Rituximab Compared With Fludarabine Phosphate, Cyclophosphamide, and Rituxim — National Cancer Institute (NCI)
BLAST MRD AML-2: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual — National Cancer Institute (NCI)
Cytarabine and Daunorubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute — Wake Forest University Health Sciences
Azacitidine With or Without Lenalidomide or Vorinostat in Treating Patients With Higher-Ri — National Cancer Institute (NCI)

全部试验

本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。

English 한국어 日本語中文 Русский