N=~320
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Key eligibility criteria*:
- Previously untreated CLL/SLL
- Measurable nodal disease by CT, defined as ≥1 lymph node ≥1.5 cm in longest diameter
- ECOG PS 0–2 for ibrutinib monotherapy; ECOG PS 0 or 1 for combination therapy
Primary outcome:
- Best ORR (CR, CRi, nPR, or PR) per iwCLL 2018 criteria as assessed by investigator
Secondary outcomes‡:
- CR rate
- DOR
- PFS
- OS
- MRD-negativity rate
- PROs
- AEs
- Discontinuation/reductions due to AEs
- Adherence rates
- BTKO (Cohort 2)
- PK (Cohort 2)
*Not a complete list of inclusion and exclusion criteria. †1 cycle = 28 days. ‡Not a complete list of secondary outcomes.
AE, adverse event; BTKO, Bruton’s tyrosine kinase occupancy; CLL, chronic lymphocytic leukemia; CR, complete response; CRi, complete remission with incomplete hematological recovery; CT, computed tomography; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; iwCLL, International Workshop on Chronic Lymphocytic Leukemia; MRD, minimal residual disease; nPR, nodular partial response; ORR, overall response rate; OS, overall survival; PD, progressive disease; PFS, progression-free survival; PK, pharmacokinetics; PR, partial response; PRO, patient-reported outcome; QD, once daily; R, randomized; SLL, small lymphocytic lymphoma.