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NCT06367374Not yet recruitingPhase 2

MRD Guided Sonrotoclax and Zanubrutinib in Newly Diagnosed CLL/SLL

A Single Arm, Open-label Study of MRD-Guided Zanubrutinib in Combination With Sonrotoclax in Adult Patients With Treatment Naïve Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Source: ClinicalTrials.gov · Last updated 16 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

This is a single-arm, open-label study of sonrotoclax plus zanubrutinib with MRD-driven treatment duration in patients with previously untreated Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). The primary goal of this study is to evaluate the efficacy of MRD-guided zanubrutinib plus sonrotoclax for first-line CLL/SLL treatment.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
66 (estimated)
First submitted
20 Mar 2024
Start date
30 May 2024
Primary completion date
28 Feb 2030
Lead sponsor
Institute of Hematology & Blood Diseases Hospital, China
NCT number
NCT06367374

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 66
  • From 30 May 2024 to the primary completion date, 28 Feb 2030
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Any prior systemic therapy used for treatment of CLL/SLL
  • Prior therapy with study drugs within 4 weeks before screening
  • Vaccinated with live vaccines within 28 days prior to enrollment
  • Requires treatment with a strong cytochrome P450 (CYP) 3A inhibitor

Other illness

  • With history of prolymphocytic leukemia, known or currently suspected Richter's transformation
  • Severe or debilitating pulmonary disease
  • Clinically significant cardiovascular disease
  • Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura requiring treatment
  • History of other malignancies
  • Active fungal, bacterial, and/or viral infection requiring systemic therapy
  • Known allergy to zanubrutinib or sonrotoclax or any pharmaceutical excipients
  • Serologically positive of human immunodeficiency virus (HIVAb), or active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
  • History of stroke or intracranial hemorrhage within 6 months

Other

  • Known central nervous system involvement by leukemia or lymphoma
  • Confirmed progressive multifocal leukoencephalopathy (PML)
  • Pregnant or lactating women

Who the study is looking for

  • Treatment naïve adult patients with diagnosis of CLL/SLL requiring treatment according to iwCLL guidelines 2018
  • Measurable nodal disease by CT/MRI.
  • Adequate hematologic function
  • Adequate hepatic and renal function
  • Eastern Cooperative Oncology Group
  • (ECOG) performance status of 0-2
  • Expected survival period \> 6 months

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.