Excluded Medications. Subjects must not take the following medications during their participation in this trial: · ***; · ***; · ***; · ***; · ***. Although the need for any antidiabetic medications at screening would exclude subjects from trial participation, subjects who develop a need for these medications during the course of the trial need not be discontinued for this reason alone. Refer to Section 5.6 for treatment and monitoring recommendations.
Excluded Medications. Corticosteroid therapy at a pharmacologic dose (> 5 mg/day of prednisone or equivalent doses of other corticosteroids) and other immunosuppressive drugs must be avoided for 7 days prior to leukapheresis and 5 days prior to anti-CD19 CAR T cells administration unless used for bridging therapy (refer to Section 6.3.2). Corticosteroids and other immunosuppressive drugs should also be avoided for 3 months after anti-CD19 CAR T cells administration unless used to manage anti-CD19 CAR T cell related toxicities (refer to Section 6.4). Other medications that may interfere with evaluation of the IP, such as non-steroidal anti-inflammatory agents, should also be avoided for the same time period unless medically necessary. Treatment for the subject’s lymphoma, such as chemotherapy, immunotherapy, targeted agents, radiation, and high dose corticosteroid, other than defined/allowed in this protocol, and other investigational agents are prohibited except as needed for treatment of disease progression after anti-CD19 CAR T cells infusion. If permissibility of a specific medication/treatment is in question, contact the Kite medical monitor.
Excluded Medications. Subjects must not take the following medications during their participation in this trial: · ***; · ***; · ***; · ***; · ***. Although the need for any antidiabetic medications at screening would exclude subjects from trial participation, subjects who develop a need for these medications during the course of the trial need not be discontinued. Should antidiabetic medications be required by any trial subjects, it is recommended that *** be used initially, followed by *** and/or ***. ***, either alone or in combination with other medications, should be reserved for subjects who cannot achieve adequate control with other modes of treatment. *** are prohibited, and subjects requiring treatment with these medications must be discontinued from the trial. Subjects whose *** cannot be adequately controlled with the concomitant treatments allowed in this trial should be discontinued and referred back to their primary health care provider for further follow-up (see Section 6.3).
Excluded Medications. Corticosteroid therapy at a pharmacologic dose (> 5 mg/day of prednisone or equivalent doses of other corticosteroids) and other immunosuppressive drugs must be avoided for 7 days prior to leukapheresis and 5 days prior to KTE-X19 infusion. Systemic corticosteroids should be avoided as premedication in subjects for whom CT scans with contrast are contraindicated (ie, subjects with contrast allergy or impaired renal clearance). If possible, such subjects should undergo non-contrast CT scans or alternative imagine modality (such as MRI) instead. Corticosteroids and other immunosuppressive drugs should also be avoided for 3 months after KTE-X19 infusion, unless used to manage KTE-X19 related toxicities (Refer to the most current version of the IB; see Section 6.4). Other medications which may interfere with evaluation of KTE-X19, such as non-steroidal anti-inflammatory agents should also be avoided for the same time period unless medically necessary. Therapeutic doses of systemic anticoagulants, such as unfractionated heparin and low-molecular weight heparin, should be avoided anytime subjects are at risk of bleeding due to thrombocytopenia when possible. If a subject requires the initiation of therapeutic anticoagulant doses prior to initiation of conditioning chemotherapy or prior to KTE-X19 infusion, then conditioning chemotherapy/KTE-X19 infusion must be held and the case discussed with the Kite Medical Monitor. For subjects with Ph+ ALL, all TKIs must be stopped at least 1 week prior to KTE-X19 infusion, including but not limited to imatinib, dasatinib, and ponatinib. In subjects who achieve CR, a TKI may be resumed 2 months after KTE-X19 infusion. See Section 6.3, Table 2 for use of TKIs during bridging chemotherapy. CSF prophylaxis may be given post-KTE-X19 infusion per investigator discretion in accordance with institutional guidelines, but should be avoided for at least 8 weeks after KTE-X19 infusion if possible. Treatment for the subject’s leukemia such as chemotherapy, immunotherapy, targeted agents, radiation, high dose corticosteroid, other than defined/allowed in this protocol, and other investigational agents are prohibited except as needed for treatment of disease progression after KTE-X19 infusion. If permissibility of a specific medication/treatment is in question, contact the Kite Pharma medical monitor. Medications with sedative properties should be avoided if possible in the setting of neurologic events (refer to the KTE-X19 IB).
Excluded Medications. Subjects may not use any of the following medications during participation in this study. Subjects who develop a need for any of these medications must be discontinued from the study: • Anticonvulsants used for treatment of seizure disorder, including barbiturates, benzodiazepines, GABA analogues, hydantoins, phenyltriazines, succinimides, and other agents (valproic acid and its derivatives, carbamazepine and its derivatives, zonisamide, and felbamate); • Tricyclic antidepressants, MAOIs, lithium, levodopa, and dopamine receptor agonists; • Carbonic anhydrase inhibitors; • Insulin, sulfonylureas (SFUs), GLP-1 agonists, SGLT-1 inhibitors, and SGLT-2 inhibitors; • Chronic systemic steroids (i.e. glucocorticoids, anabolic steroids) other than oral contraceptives; • Treatment for hyperactivity disorder; or • OTC, prescription medications, herbal agents and dietary supplements used with the intention to lose body weight.
Excluded Medications. The following medications and treatments are prohibited during study participation. Any investigational agent or device other than TVB-2640. Strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4). (Refer to the following for examples: xxxx://xxx.xxx.xxx/drugs/developmentapprovalprocess/developmentresources/drugin teractionslabeling/ucm093664.htm.) Drugs historically associated with NAFLD (amiodarone, methotrexate, systemic glucocorticoids, tetracyclines, tamoxifen, estrogens at doses greater than those used for hormone replacement, anabolic steroids, valproic acid, and other known hepatotoxins). Glucagon-like peptide analogue or a complex oral OAD regimen (3 or more OADs). Insulin dose adjustment >10%. (Subjects receiving insulin at baseline who require a >10% dose adjustment for the management of Type 2 diabetes mellitus are to be discontinued from the study.) Introduction of new or changes in continuing oral diabetic medications (e.g., pioglitazone) is prohibited. Concomitant oral diabetic medications are permitted only if the dose has been stable for at least 3 months before screening and remains stable throughout study participation. Subjects requiring such treatment during study participation are to be discontinued.
