Zanubrutinib, Obinutuzumab, and Sonrotoclax in Previously Untreated Patients With CLL or SLL
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
The purpose of this study is to determine the proportion of participants who achieve undetectable measurable residual disease (uMRD) in previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Eligibility criteria
Qualifiers
Participant must have CLL or SLL (WHO criteria).
Participant must require treatment according to iwCLL guidelines.
Prior local radiation for symptomatic disease is permitted.
Short course systemic corticosteroids is permissible for disease control, improvement of performance status, or non-cancer indication. However, duration of steroid course must be ≤14 days with maximum daily dose of ≤100 mg prednisone, ≤20 mg dexamethasone, or equivalent, and must be discontinued prior to study treatment (last dose may be administered up until the morning of / prior to study treatment). Inhaled steroids, topical steroids, and replacement / stress corticosteroids are permitted independent of above rules. In cases of autoimmune complications of CLL (e.g., ITP or AIHA), steroid usage is permitted.
Disqualifiers
Known histologic transformation from CLL or SLL to an aggressive lymphoma (i.e., Richter's transformation).
Known central nervous system involvement with CLL or SLL.
Other diagnosis of active malignancy or systemic therapy within 2 years of study treatment. Note: An active malignancy or systemic therapy within 2 years for another malignancy, whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Also, local/regional therapy with curative intent such as surgical resection or localized radiation at any timepoint is permitted.
Any uncontrolled illness that in the opinion of the investigator would preclude administration of study therapy (e.g., significant active infections, hypertension, angina, arrhythmias, pulmonary disease, or autoimmune dysfunction).
Trial design
Treatments tested in this trial
- Zanubrutinib
- Sonrotoclax
- Obinutuzumab
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Massachusetts General Hospital
Lead sponsor
BeOne Medicines
Collaborator
Source ClinicalTrials.gov