Addition of ritonavir to ibrutinib treatment in patients with chronic leukemia and certain types of lymphoma
Key facts
- Where
- 's-Gravenhage, 'S-Hertogenbosch, Almelo, Amersfoort, Amstelveen, Amsterdam, Apeldoorn, Breda, Doetichem, Emmen, Goes, Gouda, Groningen, Hoofddorp, Hoorn Nh, Leeuwarden, Nieuwegein, Rotterdam, Tilburg, Venlo, Zaandam és Zwolle, HollandiaSee the 24 sites
- Phase
- 2. fázis
Where in Hollandia
- Haga Hospital's-Gravenhage, HollandiaToborzás még nem indult
- Jeroen Bosch Ziekenhuis Stichting'S-Hertogenbosch, HollandiaToborzás még nem indult
- Ziekenhuisgroep Twente StichtingAlmelo, HollandiaToborzás még nem indult
- Meander Medisch CentrumAmersfoort, HollandiaToborzás még nem indult
- Ziekenhuis AmstellandAmstelveen, HollandiaToborzás még nem indult
- Amsterdam UMC StichtingAmsterdam, HollandiaToborzás még nem indult
- Stichting OLVGAmsterdam, HollandiaToborzás még nem indult
- Gelre HospitalsApeldoorn, HollandiaToborzás még nem indult
- Amphia HospitalBreda, HollandiaToborzás még nem indult
- Slingeland HospitalDoetichem, HollandiaToborzás még nem indult
- Treant Ziekenhuiszorg StichtingEmmen, HollandiaToborzás még nem indult
- Admiraal De Ruyter Ziekenhuis B.V.Goes, HollandiaToborzás még nem indult
- Groene Hart ZiekenhuisGouda, HollandiaToborzás még nem indult
- Martini Ziekenhuis StichtingGroningen, HollandiaToborzás még nem indult
- Universitair Medisch Centrum GroningenGroningen, HollandiaToborzás még nem indult
- Spaarne Gasthuis StichtingHoofddorp, HollandiaToborzás még nem indult
- Dijklander ZiekenhuisHoorn Nh, HollandiaToborzás még nem indult
- Frisius MCLeeuwarden, HollandiaToborzás még nem indult
- St. Antonius ZiekenhuisNieuwegein, HollandiaToborzás még nem indult
- Ikazia ZiekenhuisRotterdam, HollandiaToborzás még nem indult
- Stichting Elisabeth-TweeSteden ZiekenhuisTilburg, HollandiaToborzás még nem indult
- Stichting Viecuri Medisch Centrum voor Noord-LimburgVenlo, HollandiaToborzás még nem indult
- Zaans Medisch Centrum StichtingZaandam, HollandiaToborzás még nem indult
- Isala Klinieken StichtingZwolle, HollandiaToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting
- Trial code
- EU 2026-526101-15-00
- Record updated
- 2026. október 12.
- Original description
Run-in phase: To demonstrate that ritonavir-boosted low-dose ibrutinib provides adequate systemic exposure relative to standard-dose ibrutinib. Extension phase: To assess the toxicity of a defined schedule of ritonavir added to ibrutinib in adult patients with chronic lymphocytic leukemia (CLL), lymphoplasmacytic lymphoma (LPL), and mantle cell lymphoma (MCL)Read full original descriptionShow less
HOVON 185: Pharmacokinetic boosting of ibrutinib with ritonavir in patients with chronic lymphocytic leukemia, lymphoplasmacytic- and mantle cell lymphoma
Run-in phase: To demonstrate that ritonavir-boosted low-dose ibrutinib provides adequate systemic exposure relative to standard-dose ibrutinib. Extension phase: To assess the toxicity of a defined schedule of ritonavir added to ibrutinib in adult patients with chronic lymphocytic leukemia (CLL), lymphoplasmacytic lymphoma (LPL), and mantle cell lymphoma (MCL)
Inclusion: ≥ 18 years; Patients with a diagnosis of chronic lymphocytic leukemia (CLL), lymphoplasmacytic lymphoma (LPL) or mantle cell lymphoma (MCL) according to the World Health Organization classification (WHO 2024); Patients receiving ibrutinib > 60 days at the time of inclusion without any dose-reduction; World Health Organization performance status (WHO PS) 0, 1 or 2; Adequate renal and hepatic functions as indicated by the laboratory values described in the protocol unless clearly disease related; Patient is able and willing to adhere to the study visit schedule and other protocol requirements; Patient is capable of giving informed consent; Written informed consent.
Exclusion: Diagnosis of any previous or concomitant malignancy: – except when the patient successfully completed treatment (chemotherapy and/or surgery and/or radiotherapy) with curative intent for this malignancy at least 24 months prior to registration, – except for basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix,; Current concomitant chemotherapy, radiation therapy, or immunotherapy; Participation in another interventional clinical study at the time of inclusion or during protocol treatment without prior approval; Essential use of strong inhibitors or inducers of Cytochrome P450 3A (CYP3A), Cytochrome P450 2D6 (CYP2D6), Uridine Diphosphate glucuronosyltransferase (UGT) or P glycoprotein (P gp) or substrates of the aforementioned enzymes with a narrow therapeutic window; Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled: infection, autoimmune hemolysis, immune thrombocytopenia, diabetes, hypertension, hyperthyroidism or hypothyroidism etc.); Ongoing active bacterial, viral, fungal, mycobacterial, parasitic or other infection requiring systemic treatment (excluding prophylactic treatment) at the time of enrollment or within the previous 2 weeks prior to Cycle 1 Day 1 (C1D1); History of stroke or intracranial hemorrhage within 6 months prior to registration; Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; Intolerability, contra-indication or allergy to one of the study drugs; Cardiac dysfunction as defined by: – Myocardial infarction within the last 3 months of study registration, – Heart failure (NYHA) grade IV), – Unstable cardiac arrhythmias; History of non-compliance to medical regimens or considered unreliable with respect to compliance; Senile dementia, mental impairment or any other psychiatric disorder that prohibits the patient from understanding and giving informed consent; Fertile men or women of childbearing potential (WOCBP) unless: (1) surgically sterile or ≥ 2 years after the onset of menopause; (2) willing to use a highly effective contraceptive method during study treatment and until 3 months after ibrutinib treatment; Symptomatic central nervous system (CNS) involvement.