N=~320
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the J&J Clinical Trial Finder
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
- HRQoL
- Safety
- Discontinuation/reductions due to AEs
- Adherence rates
*Not a complete list of inclusion and exclusion criteria. †1 cycle = 28 days. ‡Not a complete
list of secondary outcomes.
AE, adverse event; BTK, Bruton’s tyrosine kinase; 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; HRQoL, health-related quality of life; 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; PR, partial response; QD, once daily; R,
randomized; SLL, small lymphocytic lymphoma.