Clinical Trial

CLL Induction Treatment With Venetoclax and Ibrutinib, Followed by Ibrutinib and Obinutuzumab in Patients With MRD.

Active, Not Recruiting Phase 2
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Record status
This record was last updated August 23, 2021 (before its estimated December 1, 2025 completion). Its status may not reflect the trial's current state.
Summary
A recent study showed that 6 cycles of obinutuzumab when given after at least 1 year of ibrutinib did result in MRD conversion in a significant proportion of patients (50%). The precise influence, timing and interplay of venetoclax, ibrutinib and obinutuzumab on clearance of CLL cells in different compartments (PB, BM, LN), and achievement of uMRD and complete remission (CR) are not well known. Therefore, the investigators set out a study to evaluate whether patients who are not in CR or who have detectable MRD after 12 months of combination treatment with ibrutinib and venetoclax (15 months total treatment including three months ibrutinib lead-in) could be converted into uMRD CR with an additional 6 cycles obinutuzumab in combination with ibrutinib.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2020-11-17; most recent amendment 2021-08-20.
Status change: Recruiting → Active, Not Recruiting 2021-08-20
Status change: Not Yet Recruiting → Recruiting 2020-12-29
Trial Details
NCT Number NCT04639362
Lead Sponsor Stichting Hemato-Oncologie voor Volwassenen Nederland
Collaborators: Nordic Lymphoma Group
Conditions CLL
Enrollment 85 participants
Start Date 2020-12-29
Primary Completion 2025-12-01 (estimated)
Study Completion 2028-12-01 (estimated)
Updated on ClinicalTrials.gov 2021-08-23