Correspondence: Richard T. Maziarz, Adult Blood and Marrow Stem Cell Transplant & Cellular Therapy Program, Knight Cancer Institute, Oregon Health and Science University, Mail code: OC14HO, 3181 SW Sam Jackson Park Rd, Portland, OR 97239; e-mail: maziarzr@ohsu.edu. Brentuximab vedotin as consolidation therapy after autologous stem-cell transplantation in patients with Hodgkin's lymphoma at risk of relapse or progression (AETHERA): a randomised, double-blind, placebo-controlled, phase 3 trial. -, Moskowitz Craig H, Nademanee Auayporn, Masszi Tamas, Agura Edward, Holowiecki Jerzy, Abidi Muneer H, Chen Andy I, Stiff Patrick, Gianni Alessandro M, Carella Angelo, Osmanov Dzhelil, Bachanova Veronika, Sweetenham John, Sureda Anna, Huebner Dirk, Sievers Eric L, Chi Andy, Larsen Emily K, Hunder Naomi N, Walewski Jan. Brentuximab vedotin as consolidation therapy after autologous stem-cell transplantation in patients with Hodgkin's lymphoma at risk of relapse or progression (AETHERA): a randomised, double-blind, placebo-controlled, phase 3 trial. Arora A, Bhatt VR, Liewer S, Armitage JO, Bociek RG. This site needs JavaScript to work properly. 0000003200 00000 n Monitor Closely (1)phenytoin decreases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Careers. Avoid coadministration with sensitive CYP3A substrates. Use Caution/Monitor. 0000007690 00000 n ADL, activities of daily living; CSF, cerebrospinal fluid; EEG, electroencephalogram; ICP, intracranial pressure. Serious - Use Alternative (1)erdafitinib will increase the level or effect of brentuximab vedotin by P-glycoprotein (MDR1) efflux transporter. Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. Only NT with at least temporal association with CAR-T cell therapy was considered for regrading. restrictions. . Bridging chemotherapy was permitted during the manufacturing interval.10 Lymphodepleting chemotherapy was omitted in a minority of patients with a white cell count lower than 1000 cells/mm2 1 week before tisagenlecleucel infusion.10, The primary endpoint of the JULIET trial was overall response rate (partial responses plus complete responses) by Lugano classification25 per independent review committee assessment. Consider dose reduction of the sensitive CYP3A4 substrate(s) if unable to avoid. what you should know about this drug before using it, other drugs that may interact with this drug, and. Use Caution/Monitor. The first dose of brentuximab vedotin was administered without difficulty, at full dose (1.8 mg/kg) at a standard infusion time of 30 minutes. Finally, based on the individual examples given here, evaluating NT using the CTCAE system is highly subjective when used by practitioners to capture CAR-T-associated encephalopathy. Avoid or Use Alternate Drug. . Avoid or Use Alternate Drug. A patient with an ICE score of 0 may be classified as grade 3 ICANS if awake with global aphasia, but a patient with an ICE score of 0 may be classified grade 4 ICANS if unarousable. Individual patient-level NT data from the phase 2, single-group, global, pivotal JULIET trial (NCT02445248) were retrospectively and independently graded, using CTCAE, ASTCT, and mCRES, by 4 medical experts with experience managing patients with 3 different CD19-targeted CAR constructs. Coadministration of encorafenib with sensitive CYP3A4 substrates may result in increased toxicity or decreased efficacy of these agents. First, BVIN is highly frequent. tucatinib will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. Comment: Palifermin should not be administered within 24 hr before, during infusion of, or within 24 hr after administration of antineoplastic agents. Contraindicated because of increased risk of pulmonary toxicity. The site is secure. Monitor Closely (1)imatinib increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. % xb```f``5x2@qu5mVux"jKD. For example, if an event could not be reconciled by the 4 experts and was graded as 2, 3, 3, and 4, then grade 4 was the final grading. Avoid or Use Alternate Drug. If use is unavoidable, refer to the prescribing information of the P-gp substrate for dosage modifications. Minor/Significance Unknown. stiripentol will increase the level or effect of brentuximab vedotin by P-glycoprotein (MDR1) efflux transporter. Your doctor may need to adjust your diabetes medication, exercise program, or diet.Tell your doctor right away if you have any serious side effects, including: numbness/tingling/weakness/pain of the hands/feet/arms/legs, muscle weakness, shortness of breath, easy bruising/bleeding, signs of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine), severe diarrhea, severe constipation, black stools, vomit that looks like coffee grounds.This medication may lower your ability to fight infections. STORAGE: Not applicable. is employed by the Analysis Group, which received research funding from Novartis. Unable to load your collection due to an error, Unable to load your delegates due to an error. If you log out, you will be required to enter your username and password the next time you visit. Adding plans allows you to compare formulary status to other drugs in the same class. Vital signs were stable, with a temperature of 36.9C, pulse 84, respirations of 20, and blood pressure of 107/67 mm Hg. Only 2 of the 31 patients who had NT per CTCAE, but grade 0 NT by mCRES and ASTCT, had received corticosteroids (Table 4). Lancet Oncol. Modify Therapy/Monitor Closely. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC. Use Caution/Monitor. Monitor patients for adverse reactions. xZcj!"a]R76 l .]Y 4hf)ceA$Oq5SiG $Ulq9g'"7rED_quXlqq4x lopinavir increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. CTCAE, mCRES, and ASTCT NT grades for patients with or without CRS per Penn Scale. rifampin decreases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Results of a pivotal phase II study of brentuximab vedotin for patients with relapsed or refractory Hodgkin's lymphoma. receives research funding from Kite Pharma, a Gilead Company, and Celgene; he also receives research funding from and has patents licensed or pending with Juno Therapeutics, a Celgene/Bristol-Myers Squibb company; has participated in advisory board and/or data monitoring committee meetings for which he receives honoraria for BioLine RX, Kite Pharma, Gilead, Pharmacyclics, Novartis, Juno Therapeutics, and Celgene; and is a scientific advisory board member for which he receives honoraria from and has stock options in A2 Biotherapeutics. contributed to the study design; S.J.S. 2018, Diffuse large B-cell lymphoma (DLBCL): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Use Caution/Monitor. Use Caution/Monitor. She was treated with six cycles of chemotherapy with doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD), to which she obtained a complete response by positron emission tomography-computed tomography (PET-CT) criteria. Monitor Closely (1)rifampin decreases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. 0000005575 00000 n endobj In the majority of patients who had higher-grade NT per the CTCAE scale than the mCRES and ASTCT scales, the less specialized CTCAE scale identified NT not considered relevant for CRES or ICANS, resulting in grades of 0 by mCRES and ASTCT. Per protocol, NT events in the JULIET trial were identified and graded using the CTCAE v4.03 criteria. HHS Vulnerability Disclosure, Help Use Caution/Monitor. Canada residents can call a provincial poison control center. endstream endobj 5316 0 obj <>stream doi: 10.1007/s00280-002-0447-1. You are being redirected to Avoid or Use Alternate Drug. Severe infusion reactions to brentuximab vedotin in two patients with Hodgkin lymphoma previously treated with allogeneic stem cell transplantation. This site needs JavaScript to work properly. In the JULIET trial, NT was graded, per protocol, using CTCAE v4.03 criteria (Table 1). For example, mCRES and ASTCT criteria categorized 31 patients as having grade 0 NT compared with NT ranging from grade 1 to 3, using the CTCAE scale. posaconazole increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Specific conditions and symptoms may have values or descriptive comment for each level, but the general guideline is: 1 - Mild 2 - Moderate 3 - Severe 4 - Life-threatening 5 - Death Grade 1: is defined as mild, asymptomatic symptoms. Limit alcoholic beverages. nK Four medical experts with experience treating patients with 3 different CD19-targeted CAR-T cell constructs retrospectively assessed and regraded NT after tisagenlecleucel treatment in patients with r/r DLBCL or r/r transformed follicular lymphoma in the JULIET trial, as reported in the US Food and Drug Administration (FDA) prescribing label. Definitions and Grading of Peripheral Sensory and Motor Neuropathy (reproduced from NCI Common Terminology Criteria for Adverse Events, Version 4.03) The peripheral neuropathy associated with brentuximab vedotin is generally reversible and may often be managed with modifications to dosing and schedule. Use Caution/Monitor. Minor/Significance Unknown. voriconazole increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. tecovirimat will decrease the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Locatelli F, Mauz-Koerholz C, Neville K, Llort A, Beishuizen A, Daw S, Pillon M, Aladjidi N, Klingebiel T, Landman-Parker J, Medina-Sanson A, August K, Sachs J, Hoffman K, Kinley J, Song S, Song G, Zhang S, Suri A, Gore L. Lancet Haematol. Avoid taking selinexor with other medications that may cause dizziness or confusion. Recognizing that the CAR-T-associated NT represents a unique syndrome that would benefit from a unified scale, the multiinstitution CAR-T cell-therapy-associated Toxicity (CARTOX) Working Group introduced the term CAR-T cell-Related Encephalopathy Syndrome (CRES).23 The CARTOX group created a CRES grading system that included a 10-point questionnaire (CARTOX-10), designed to capture subtle to severe cognitive and attentive dysfunction. This strategy was based upon the results of the AETHERA phase III clinical trial (Moskowitz et al., 2015), showing improvement in progression-free survival with brentuximab vedotin consolidation therapy, post autologous transplant. . . Always ask your health care professional for complete information about this product and your specific health needs. An official website of the United States government. Avoid or Use Alternate Drug. Use Caution/Monitor. %PDF-1.6 % Your list will be saved and can be edited at any time. doi: 10.1016/s0140-6736(15)60165-9. This potential conflict of interest has been reviewed and managed by Oregon Health & Science University.