CTIS2022-501481-21-00招募中1 期
A Phase 3, Randomized Study to Compare the Efficacy and Safety of Nemtabrutinib Versus Chemoimmunotherapy for Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Without TP53 Aberrations (BELLWAVE-008) - MK-1026-008
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 212
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Confirmed diagnosis of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) and active disease clearly documented to have a need to initiate therapy, Previously untreated CLL/SLL participants without tumor protein 53 (TP53) aberrations and documented 11q status and immunoglobulin heavy chain gene (IGHV) mutational status, Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV deoxyribonucleic acid (DNA) viral load prior to randomization, Participants with history of hepatitis C virus (HCV) infection are eligible if HCV ribonucleic acid (RNA) viral load is undetectable at screening, Participants with human immunodeficiency virus (HIV) are eligible if they meet ALL of the following criteria: a) The cluster of differentiation 4 (CD4) count is >350 cells/µL at screening b) The HIV viral load is below the detectable level as per locally available testing and c) Are on a stable antiretroviral therapy (ART) regimen for at least 4 weeks prior to study entry, Male participants who can produce sperm are eligible to participate if participants agree to the protocol specific criteria regarding length of time to continue contraception plus either abstain from penile-vaginal intercourse or use contraception per protocol during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention, Female participants are eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies: is not a participant(s) of childbearing potential (POCBP) or is a POCBP and uses a contraceptive method that is highly effective with low user dependency, or is abstinent from penile-vaginal intercourse, agrees not to donate eggs to others or freeze/store during this period and agrees to the protocol specific criteria regarding length of time to continue contraception
排除标准
- •Has active HBV/HCV infection, Participants who have not adequately recovered from major surgery or have ongoing surgical complications, Currently being treated with the following drugs: a) P-glycoprotein (P-gp) substrates with a narrow therapeutic index and b) cytochrome P450 (CYP)3A strong inducers c) CYP3A strong inhibitors, Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention, Has received any systemic anticancer therapy for CLL/ SLL, or an investigational agent within 5 times the half-life (or 4 weeks for monoclonal antibody treatment) or has used an investigational device within 4 weeks for any medical condition prior to study intervention administration, Has known psychiatric or substance abuse disorder that would interfere with the participant’s ability to cooperate with the requirements of the study, Has gastrointestinal dysfunction that may affect drug absorption, Has known additional malignancy that is progressing or has required active treatment within the past 3 years, Has diagnosis of Richter Transformation or active central nervous system (CNS) involvement by CLL/SLL, Has active infection requiring systemic therapy, including intravenous (IV) antibiotics during screening, Has acquired immunodeficiency syndrome (AIDS) defining opportunistic infection in the past 12 months prior to screening, Has QT interval corrected (QTc) prolongation or other significant electrocardiogram (ECG) abnormalities including 2nd degree atrioventricular (AV) block type II, 3rd degree AV block, or bradycardia, Hypersensitivity to nemtabrutinib or contraindication to fludarabine plus cyclophosphamide plus rituximab (FCR) (or specified approved rituximab biosimilar)/bendamustine, or any of the excipients, Has history of severe bleeding disorders
研究者
相似试验
招募中
2 期
Clinical study to compare the efficacy of Ayurvedic topical medications in Vernal Keratoconjunctivitis.CTRI/2020/06/025778ational Institute Of Ayurveda Jaipur
进行中（未招募）
不适用
Comparison of injectable L-Ornithine L -Aspartate versus oral L-Ornithine L -Aspartate for treatment of Cirrhosis patients with altered behavior.CTRI/2020/12/029943BSBY Scheme Govt of Rajasthan
招募中
不适用
study to assess the efficacy of oral melatonin plus rectal indomethacin versus rectal indomethacin for the prevention of post-ercp pancreatitisCTRI/2021/03/032127BSBY Scheme Govt of Rajasthan
已完成
不适用
A randomized, controlled study comparing the efficacy of peginterferon alfa-2b plus standard or reduced dose ribavirin in serotype 2 chronic hepatitis CJPRN-C000000402Tokai University School of Medicine120
已完成
不适用
Comparing the efficacy of azathioprine and mycophenolate mofetil in patients with sunlight induced dermatitisCTRI/2021/12/038801Post Graduate Institute of Medical Education and Research Chandigarh