Zanubrutinib, Obinutuzumab and Lenalidomide in Newly Diagnosed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
NCT Number: NCT06547944
Acronym: ZGR in TN CLL
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Chronic Lymphocytic Leukemia|Small Lymphocytic Lymphoma|Newly Diagnosed
Interventions: DRUG: Zanubrutinib|DRUG: Lenalidomide|DRUG: Obinutuzumab
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-01-01
Completion Date: 2026-12-01
Locations: Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, Tianjin, China

Summary:
The ZGR regimen limited-course regimen was designed to combine three targeted agents, zanubrutinib, obinutuzumab (a third-generation CD20 monoclonal antibody), and lenalidomide, to deepen the depth of remission in patients with new-diagnosis CLL/SLL, with a view to achieving the goal of discontinuation of the drug and long-term remission after discontinuation of the drug, and prolonging the PFS, and at the same time, the regimen no longer includes cytotoxic chemotherapeutic agents, such as fludarabine and cyclophosphamide, which improves the CLL/ SLL patients' treatment tolerance, and can eliminate the treatment limitation for elderly or poorly tolerated CLL/SLL patients.

Primary Outcome Measures: Maximum Tolerated Dose (MTD) of lenalidomide in combination regimens were determined in newly diagnosed CLL/SLL patients,, From the date of first dose of study drugs until RP2D was determined(Approximately 4 months)]|The incidence, nature and severity of adverse events (AE) were determined according to NCI-CTCAE v5.0 evaluation criteria, From first dose to 30 days after the last dose of Zanubrutinib or lenalidomide or Obinutuzumab
Secondary Outcome Measures: overall response rate(ORR), Defined as the proportion of patients assessed as CR, CRi, or PR according to the IWCLL 2018 criteria at or before initiation of subsequent antitumor therapy., From first dose to 30 days after the last dose of Zanubrutinib or lenalidomide or Obinutuzumab|overall survival Overall survival(OS), Defined as the time interval from enrollment to death for patients in an intentional-treatment population (ITT). If the patient continues to survive or if his or her life is unknown, the date of death will be the nearest point in time when the patient is known to be alive., Up to 5 years|Progress-free survival(PFS), Defined as the time interval from enrollment to disease progression or death of a patient in an intention-to-treat population (ITT), whichever comes first. For those who did not progress at the time of exit or whose time to disease progression was not recorded, the last examination date was used as the end date., Up to 5 years|Duration of tumor remission(DOR), Defined as the time interval between first recorded disease remission and first recorded evidence of PD in patients in an intention-to-treat population (ITT). No progression or time to disease progression was recorded at the time of exit from the trial, with the date of last examination as the end date., Up to 5 years