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

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.

Timeline

Start

2020-12-29

Primary completion

2025-12-01

Completion

2028-12-01

Publications

• Kater AP, Kersting S, Dubois JM, van der Holt B, da Cunha-Bang C, Te Raa D, Idink C, de Boer F, Droogendijk J, de Heer K, van der Burg L, Nijziel MR, Tick L, Levenga H, Silbermann M, Ludwig I, Beeker A, Bellido M, Dobber JA, Evers LM, van der Kevie-Kersemaekers AM, Mellink C, Meulendijks I, Cunha S, Abrahamse-Testroote M, Zwezerijnen G, Zijlstra J, Niemann CU, Levin MD. Fixed-duration ibrutinib-venetoclax with MRD-guided ibrutinib-obinutuzumab intensification in first-line chronic lymphocytic leukaemia (HOVON 158/NEXT STEP): primary analysis of a multicentre, open-label, phase 2 trial. Lancet Haematol. 2025 Dec;12(12):e935-e945. doi: 10.1016/S2352-3026(25)00288-1.

Drugs

Indications