OncoMatch/Clinical Trials/NCT04771507
A Pilot Study on Intermittent Ibrutinib in Patients With Advanced-phase Chronic Lymphocytic Leukemia (CLL)
Is NCT04771507 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Ibrutinib for chronic lymphocytic leukemia.
Treatment: Ibrutinib — Ibrutinib, an inhibitor of Bruton´s tyrosine kinase (BTK) is approved in CLL as continuous, daily administration of 420 mg orally until progression. Ibrutinib drug costs in health care are rapidly increasing and are difficult to predict, as long-term follow up analyses have shown that many patients remain on therapy for several years, in some cases even many years. It has been observed that patients who stop ibrutinib due to side effects may often remain with continued CLL disease control i.e. in stable partial remission even when off ibrutinib therapy. There are also emerging data on mutations within BTK, with loss of efficacy of ibrutinib, during long-term continuous administration. These observations raise the question whether alternative dosing strategies may be feasible. This pilot study will explore intermittent and repeated dosing of ibrutinib, until alternative therapy is required due to resistance or intolerance to ibrutinib. An "ON-OFF" dosing strategy will be applied, where advanced-phase CLL patients who have received at least 6 months of ibrutinib and who have achieved a stable PR will stop ibrutinib and be followed off therapy until clinical progression, at which ibrutinib will be re-instituted. Such "ON-OFF" ibrutinib cycles may be repeated until non-tolerability or resistance, or need of continuous dosing of ibrutinib (i.e. early progression when off the drug). If successful, the study will indicate a way forward towards reducing ibrutinib drug costs in health care without affecting long-term disease control, possibly also with fewer ibrutinib-related side effects due to a lower cumulative dose of ibrutinib. Long-term effects on potential mutations within BTK and its downstream signaling molecules will also be analysed.
Check if I qualifyExtracted eligibility criteria
Cancer type
Chronic Lymphocytic Leukemia
Non-Hodgkin Lymphoma
Biomarker criteria
Allowed: TP53 mutation
del 17p and/or TP53 mutation irrespective of prior therapy
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: chemoimmunotherapy — for CLL
failed chemoimmunotherapy for CLL defined as a) refractory according to iwCLL criteria; or b) relapsed and deemed not suitable for additional chemo- or chemoimmunotherapy or c) del 17p and/or TP53 mutation irrespective of prior therapy
Must have received: BTK inhibitor (ibrutinib)
Having received at least 6 months of ibrutinib therapy and having achieved at least clinical PR according to IWCLL criteria
Cannot have received: experimental therapy
Use of any other experimental therapy within the last 14 days
Lab requirements
Blood counts
Absolute neutrophil count >= 0.5 x 10^9/L; Platelet count >= 30 x 10^9/L
Kidney function
Serum creatinine < 177 µmol/L
Liver function
ASAT (SGOT) and ALAT (SGPT) >= 2 x ULN or >= 5 x ULN unless attributable to CLL/SLL
Laboratory test results: Absolute neutrophil count >= 0.5 x 10^9/L; Platelet count >= 30 x 10^9/L; Serum creatinine < 177 µmol/L; ASAT (SGOT) and ALAT (SGPT) >= 2 x ULN or >= 5 x ULN unless attributable to CLL/SLL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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