招募中 NCT06136559

Nemtabrutinib (MK-1026)对比一线(1L)慢性淋巴细胞白血病(CLL)/小淋巴细胞淋巴瘤(SLL) (MK-1026-011/BELLWAVE-011)的研究(研究者选择Ibrutinib或Acalabrutinib)

淋巴瘤白血病Phase III

本研究的目的是在既往未接受任何治疗的慢性淋巴细胞白血病(CLL)/小淋巴细胞淋巴瘤(SLL)参与者中,评估nemtabrutinib与研究者选择ibrutinib或acalabrutinib的比较。

适应症:Chronic Lymphocytic Leukemia、Small Lymphocytic Lymphoma

入组条件

纳入标准

  • Confirmed diagnosis of CLL/SLL and active disease clearly documented to have a need to initiate therapy.
  • Has at least 1 marker of disease burden.
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days before randomization.
  • Has the ability to swallow and retain oral medication.
  • 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 before 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) who meet ALL eligibility criteria.

排除标准

  • Has an active hepatitis B virus/ hepatitis C virus (HBV/HCV) infection.
  • Has gastrointestinal (GI) dysfunction that may affect drug absorption.
  • Has diagnosis of Richter Transformation or active central nervous system (CNS) involvement by CLL/SLL.
  • Has had acquired immune deficiency syndrome (AIDS)-defining opportunistic infection in the past 12 months before screening.
  • Has clinically significant cardiovascular disease.
  • Has hypersensitivity to nemtabrutinib or contraindication to ibrutinib or acalabrutinib, or any of the excipients.
  • Has history of severe bleeding disorder.
  • Has known additional malignancy that is progressing or has required active treatment within the past 2 years.
  • Has received any systemic anticancer therapy for CLL/SLL.
  • Is currently being treated with p-glycoprotein (P-gp) substrates with a narrow therapeutic index, cytochrome P450 3A (CYP3A) strong or moderate inducers or CYP3A strong inhibitors.
  • Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.
  • Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
  • Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration.
  • Has active infection requiring systemic therapy, including intravenous (IV) antibiotics during screening.
  • Participants who have not adequately recovered from major surgery or have ongoing surgical complications.

入组条件维持 ClinicalTrials.gov 原始英文登记资料,实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源:ClinicalTrials.gov,每两周自动更新,最后同步:2026年10月8日。