Subcutaneous Rituximab with or without Ibrutinib, Maintenance Period - ENRICH Study
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1 Subcutaneous Rituximab with or without Ibrutinib, Maintenance Period Study Randomised, open label study of Rituximab/Ibrutinib vs Rituximab/Chemotherapy in older patients with untreated mantle cell lymphoma ***See protocol for further details*** Available for Routine Use in Burton in-patient Derby in-patient Burton day-case Derby day-case Burton community Derby community Burton out-patient Derby out-patient Treatment Intent Maintenance Anti-Emetics Pre-chemotherapy Nil Post-chemotherapy Nil Indication Maintenance therapy in Mantle Cell Lymphoma Frequency & Duration Rituximab (Both control and interventional arm) - every 2 months until disease progression, withdrawal from treatment or for a maximum period of two years, (12 cycles) Ibrutinib (Interventional arm ONLY) continuously for 2 years with rituximab during maintenance period, and then continuously during the follow up period until disease progression or end of trial. Day 1 Ibrutinib (Trial Stock) 560mg (4x140mg capsules) Oral once daily continuously Chlorphenamine 4mg Oral 30 minutes prior to rituximab Paracetamol 1g Oral 30 minutes prior to rituximab Rituximab SUBCUTANEOUS formulation 1400mg Subcutaneous injection over approx. 5 minutes Notes: 1. Please note that there are TWO different formulations of rituximab (Intravenous AND Sub-cutaneous). ALWAYS confirm the intended route of administration and prescribe using the appropriate order-set. See separate QACS protocols for each route. AUTHORISED BY: Dr J Addada PAGE 1 of 5
2 2. Before starting subcutaneous rituximab, all patients must always receive beforehand, a full dose of rituximab by intravenous infusion, using the intravenous formulation. 3. Premedication consisting of analgesia and an antihistamine should always be administered 30 minutes before each infusion of rituximab (e.g. paracetamol 1g oral STAT and chlorphenamine 4mg oral). If participants cannot tolerate subcutaneous administration of rituximab, intravenous administration may be used as an alternative following discussion with the trial manager. If subcutaneous dosing is continued, add 30mg prednisolone orally 30 minutes prior to all future subcutaneous rituximab doses. 4. Patients should be observed for at least 15 minutes following subcutaneous injection. 5. If an injection is interrupted it can be resumed at the same site or another location may be used, if appropriate. 6. Although rituximab is not myelosuppressive, caution should be exercised when considering treatment of patients with neutrophils < 1.5 x 10 9 /l and/or platelet counts < 75 x 10 9 /l, as clinical experience in this population is limited. 7. Suggest monitor serum immunoglobulins on a 3 monthly basis. If IgG falls below 3g/l, discontinue rituximab. 8. Ibrutinib a) 560 mg (4 x 140mg capsules) of ibrutinib should be taken orally once daily with approximately 240mls of water. The capsules should be swallowed intact with or without food at approximately the same time each day. The first dose will be given in clinic on day 1, cycle 1 before rituximab is administered. Subsequent doses will be taken by the participant at home. b) If a dose is missed, it can be taken up to 6 hours after the scheduled time with a return to the normal schedule the following day. If the dose is more than 6 hours late, the dose should not be taken and the participant should take the next dose at the scheduled time the following day. c) Strongly or moderately inhibitors of CYP3A Concomitant use of ibrutinib and drugs that strongly or moderately inhibit CYP3A can increase ibrutinib exposure and should be avoided. Strong inhibitors AUTHORISED BY: Dr J Addada PAGE 2 of 5
3 of CYP3A (e.g., ketoconazole, indinavir, nelfinavir, ritonavir, saquinavir, clarithromycin, telithromycin, itraconazole, nefazadone and cobicistat) and moderate inhibitors (e.g., voriconazole, erythromycin, amprenavir, aprepitant, atazanavir, ciprofloxacin, crizotinib, darunavir/ritonavir, diltiazem, fluconazole, fosamprenavir, imatinib, verapamil, amiodarone, dronedarone) should be avoided. If the benefit outweighs the risk and a strong CYP3A inhibitor must be used, reduce the ibrutinib dose to 140 mg or withhold treatment temporarily (for 7 days or less). If a moderate CYP3A inhibitor must be used, reduce ibrutinib treatment to 140 mg for the duration of the inhibitor use. No dose adjustment is required in combination with mild inhibitors. Monitor patient closely for toxicity and follow dose modification guidance as needed. Avoid grapefruit and Seville oranges during ibrutinib treatment as these contain moderate inhibitors of CYP3A. d) Strong inducers of CYP3A Administration of ibrutinib with strong inducers of CYP3A decreases ibrutinib plasma concentrations by up to 90%. Avoid concomitant use of strong CYP3A inducers (eg, carbamazepine, rifampin, phenytoin and St. John s Wort). Consider alternative agents with less CYP3A induction. e) Anticoagulants and Antiplatelets Warfarin or equivalent vitamin K inhibitors should not be given concomitantly whilst the participant is receiving ibrutinib. For participants requiring anticoagulant therapy, LMW heparin or an alternative new oral anticoagulant drug should be considered instead. Anti-platelet drugs may be used with ibrutinib but can be associated with increased bruising and bleeding. Therefore participants on these agents should be monitored for any significant change in bruising or bleeding. f) QT Prolonging Agents Any medications known to cause QT prolongation (see Protocol, Appendix 4) should be used with caution; periodic monitoring with electrocardiograms (ECGs) and serum electrolytes should be considered. Use of these medications should first be discussed with the Chief Investigator or delegated deputy. g) Surgery AUTHORISED BY: Dr J Addada PAGE 3 of 5
4 Ibrutinib should be held at least 3-7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding, see Protocol section for further details. h) Live Vaccines Use of live vaccinations is prohibited during the study and for three months after last dose of the ibrutinib. 9. Toxicities - Dose Delay, Reduction and Discontinuation Ibrutinib Possible drug toxicities: Grade 3 or greater neutropenia with infection or fever Grade 4 neutropenia (absolute neutrophil count <0.5 x 10 9 /L) Grade 3 thrombocytopenia (platelets <50 x 10 9 /L) in the presence of significant bleeding Grade 4 thrombocytopenia (platelets <25 x 10 9 /L) Grade 3 or greater non-haematological toxicity Occurrence First Second Third Fourth Ibrutinib Dose Modifications Action Hold ibrutinib until recovery to Grade 1; may restart at original dose level Hold ibrutinib until recovery to Grade 1; restart at one dose level lower (420 mg daily) Hold ibrutinib until recovery to Grade 1; restart a further dose level lower (280 mg daily) Discontinue ibrutinib A maximum of two dose level reductions are permitted during the study. Once the ibrutinib dose is reduced, it cannot be re-escalated. Study drug may be omitted for a maximum of 28 consecutive days for toxicity. It should be permanently discontinued in the event of a toxicity lasting more than 28 days, unless agreement is sought from the Chief Investigator. Renal Impairment AUTHORISED BY: Dr J Addada PAGE 4 of 5
5 No dose adjustment is needed for patients with mild or moderate renal impairment (greater than 30 ml/min creatinine clearance). Hydration should be maintained and serum creatinine levels monitored periodically. Hepatic Impairment Ibrutinib is metabolized in the liver and preliminary data shows an increase in ibrutinib exposure in patients with hepatic impairment. For patients with mild liver impairment (Child-Pugh class A), the recommended dose is 280 mg daily (two capsules). For patients with moderate liver impairment (Child-Pugh class B), the recommended dose is 140 mg daily (one capsule). It is not recommended for patients with severe hepatic impairment. Rituximab No dose reductions of rituximab are recommended. Rituximab can be withheld for a maximum of 28 consecutive days. A hold greater than 28 days must be reviewed and approved by the Chief Investigator. Rituximab should be permanently discontinued if it cannot be restarted within a further 28 days due to toxicity or in the opinion of the Chief Investigator. If rituximab is discontinued for toxicity, treatment with ibrutinib may continue. 10. Supportive Care a) If lymphocytes fall below 1.0x10 9 /l commence: Co-trimoxazole 480mg ONCE daily. In cases of allergy to co-trimoxazole, consider dapsone 100mg daily. Aciclovir 400mg twice daily. b) GCSF may be given as per routine practice. References 1. Standard Care QACS Subcutaneous Rituximab, version 2, 28/11/14 by C Ward. 2. ENRICH Protocol version V4, 19 th October Janssen-Cilag Ltd Summary of Product Characteristics Ibrutinib (Imbruvica), last updated 29th March 2016 (accessed online 18th April 2016). AUTHORISED BY: Dr J Addada PAGE 5 of 5
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