CAR-T. Subrena Powell RN, MSN, BMTCN
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1 CAR-T Subrena Powell RN, MSN, BMTCN
2 Objectives Discuss the treatment timeline of a patient receiving CAR-T therapy Describe the side effects and management of symptoms of CAR-T therapy
3 Treatment Schema
4 CASE STUDY Patient is a 27 year old male diagnosed with ALL No response to prior treatment of Hyper CVAD
5 1 st Stop: BMT Clinic and Treatment Center
6 BMT Clinic & Treatment Center Vital organ testing Enrolled in CAR-T trial Education from a Transplant Nurse Coordinator Line Placement and Leukapheresis Cells shipped fresh for CAR-T cell manufacture
7 Conditioning Chemotherapy Fludarabine 25mg/m 2 on Days -4,-3,-2 Cyclophosphamide 900mg/m 2 on Day -2 Mesna 300mg/m 2 on Day -2 Hourly voids Palonestron 0.25mg IV on Days -4 and -2
8 2 nd Stop: BMT Inpatient Unit
9 Admission Admission on Day -1 to the Immune Cell Therapy (ICE-T) Service ICE-T Care Team: ICE-T Attending Physician ICE-T designated Advance Practice Provider (APP) An assigned inpatient nurse educated on ICE-T trials Case manager, Dietary, PT/OT, ID, Neurology, etc. Clinical Trial coordinator
10 Day 0: pre CAR-T Assessment Hematology: WBC: 0.30, Hgb: 8.5, Plt: 35, ANC: 200 Neurological: Patient Alert and Oriented, MMSE: 30/30 Respiratory: Room Air Cardiovascular: Within normal range
11 Day 0: CAR-T Infusion Infusion Normal saline given prior to infusion of cells Pre-medication with Tylenol and Benadryl Infusion of Cells Post infusion normal saline Then monitor V/S during and q3 hours post transfusion
12 Neurological Toxicities Patients are at risk for neurotoxicity's associated with CAR-T infusion/cytokine Release Syndrome Prophylaxis/Monitoring includes: Keppra 1000mg BID started prior to infusion for seizure prophylaxis Neuro checks q4h & PRN Mini Mental Status Examination (MMSE) by providers on: Day 0 Day 1 Then every other day and PRN
13 Mini-Mental State Examination (MMSE) Brief quantitative assessment of cognitive impairment Examines orientation, memory, attention, calculation, language and praxis. Maximum score = 30 Score of 23 indicates cognitive impairment
14 Cytokine Release Syndrome (CRS) Serious complication which may occur after infusion of CAR-T cells Cytokines and chemokines are released by the activated CAR-T cells and produce a systemic inflammatory response, similar to that found in severe infection IL-6 IFN-gamma Close monitoring by nursing staff is essential
15 CRS Clinical Features (Brudno & Kochenderfer, 2016).
16 Day +1 Assessment Hematology: WBC: 0.19, Hgb: 6.3, Plt: 40, ANC: <500 Neurological: Alert, oriented, able to participate in care MMSE: 26/30 Respiratory: Room Air Cardiovascular: Normotensive Daily Events Patient became febrile, Tmax: 39.3º C Blood Cultures completed Chest X-Ray completed (-) Antibiotics started within an hour of fever
17 Day +2 Assessment Hematology: WBC: 0.21, Hgb: 8.0, Plt: 43, ANC: <500 Neurological: Alert, oriented, able to participate in care Respiratory: Room Air Cardiovascular: Normotensive Daily Events Patient remains febrile, Tmax: 39º C
18 Day +3 Assessment Hematology: WBC: 0.15, Hgb: 7.6, Plt: 43, ANC: <500 Neurological: Alert, oriented, able to participate in care MMSE: 26/30 Respiratory: Room Air Cardiovascular: Normotensive Daily Events Patient remains febrile, Tmax: 40.5º C Cultures negative to date
19 Day +4 Assessment Hematology: WBC: 0.10, Hgb: 7.5, Plt: 32, ANC: <500 Neurological: Alert, oriented, able to participate in care Respiratory: Room air Cardiovascular: Normotensive Daily Events Patient remains febrile, Tmax: 40.3º C Cultures negative to date
20 Day +5: Early Morning 0000: Alert, oriented, still febrile, Tmax 40.5º C 0300: Became obtunded Episode of emesis Could no longer verbally communicate Able to track with eyes, but no motor strength 0600: Seizure-like activity noted Foaming at the mouth Jaw Clenching Upturned Eyes Given Ativan 2mg IV some improvement noted
21 Day +5: Afternoon Assessment Hematology: WBC: 0.14, Hgb: 6.8, Plt: 37, ANC: <500 Neurological: Rapid mental status changes prompted ICE-T provider to order: Dexamethasone 10 mg IV q6hrs Tocilizumab 8mg/kg IV x1 Neurology consulted for worsening neurotoxicity's EEG completed (-) MRI ordered: Not completed, possible V-Tach while in MRI machine, test stopped Respiratory: Pulmonary Critical Care consulted Increasingly tachypnea, RR 30-40s At 1400: Intubation to protect airway r/t to neurological state and body composition Cardiovascular: Patient increasingly tachycardic, HR 140s, B/P stable EKG: Sinus Tachycardia Cardiac Enzymes (-) ***Patient transferred to ICU***
22 Tocilizumab (Actemra) Humanized monoclonal antibody against the Interleukin 6 (IL 6) receptor Works by blocking the activity of IL 6, a substance in the body that causes inflammation Used for the treatment of CRS after CAR-T cell therapy
23 Day +6 Assessment Hematology: WBC: 0.22, Hgb: 8.3, Plt: 33, ANC: 130 Neurological: Grade 3 Neurotoxicity No more seizure activity noted MRI performed: small infarct in right inferior cerebellum Dexamethasone 10 mg IV q6hrs Respiratory: Remains intubated Sedation: Propofol/Fentanyl Cardiovascular: Patient remains normotensive
24 Day +7 Assessment Hematology: WBC: 0.21, Hbg: 6.6, Plt: 23, ANC: 110 Neurological: No seizure activity noted Patient on Dexamethasone 20 mg q12 Per Neurology: MRI findings would not explain CNS changes Respiratory: Patient remains intubated and sedated Weaning sedation: opens eyes but otherwise no motor response Cardiovascular: Patient remains in NSR, heart rate within normal range
25 Day +8 Assessment Hematology: WBC: 0.43, Hgb: 8.8, Plt: 38, ANC: 120 Neurological: Patient on Dexamethasone 20mg q12 Respiratory: 1100 On O 2 2L Cardiovascular: Remains in NSR, heart rate within normal range ECHO (-)
26 Day +9 Assessment Hematology: WBC: 0.54, Hgb: 9.0, Plt: 56, ANC: 120 Neurological: Afebrile, Cultures negative Patient on Dexamethasone 20mg q24 Patient neurologically intact MMSE: 21/30 Respiratory: Room Air Cardiovascular: Remains in NSR, heart rate within normal range ***Patient transferred back to BMT Unit***
27 Day +10 Assessment Hematology: WBC: 0.45, Hgb: 8.8, Plt: 68, ANC: 150 Neurological: Neurologically intact Afebrile, Cultures negative Dexamethasone discontinued Keppra continued Respiratory: Room Air Cardiovascular: Remains in NSR, heart rate within normal range
28 Day +11 Day +14 Assessment Hematology: Day +14: WBC: 1.01, Hgb: 9.7, Plt: 71, ANC: 910 Neurological: Patient neurologically intact Afebrile, Cultures negative Keppra continued Respiratory: Room Air Cardiovascular: Remains in NSR, heart rate within normal range
29 Day +15: Discharge Assessment Hematology: WBC: 1.35, Hgb: 9.4, Plt: 65, ANC: 1010 Bone Marrow Biopsy: No morphological evidence of residual B lymphoblastic leukemia Neurological: Alert, oriented, following commands MMSE 23/30 Respiratory: Room air Cardiovascular: Remains in NSR, heart rate within normal range PT/OT: Recommendation: Home independently
30 3 rd Stop: BMT Clinic and Treatment Center
31 Outpatient Follow Up Patient is monitored with daily labs in BMT Treatment Center following discharge Once patient becomes more stable they are seen less frequently Patient recovers and is discharged back to their primary oncologist Plan Post CAR-T is to bridge to allograft once counts are recovered and donor is found
32 References Balch, C. M., Fox, B. A., & Kaufman, H. L. (Eds.). (2015). Patient resource cancer guide: Understanding cancer immunotherapy (2nd ed.). Overland Park, KS: Patient Resource. Brudno, J. N. & Kochenderfer, J. N. (2016). Toxicities of chimeric antigen receptor Tcells: Recognition and management. Blood, 127, doi: /blood Davila, M. L., Riviere, I., Wang, X., Bartido, S., Park, J., Curran, K., & Brentjens, R. (2014). Efficacy and toxicity management of 19-28z CAR T cell therapy in B cell acute lymphoblastic leukemia. Science Translational Medicine, 6(224), doi: /scitranslmed Kannan, R., Madden, K., & Andrews, S. (2014). Primer on immuno-oncology and immune response. Clinical Journal of Oncology Nursing, 18(3), doi: /14.CJON
33 References Kochenderfer, J. N., Dudley, M. E., Kassim, S. H., Somerville, R. P., Carpenter, R. O., Stetler-Stevenson, M.,... & Raffeld, M. (2015). Chemotherapy-refractory diffuse large B-cell lymphoma and indolent B- cell malignancies can be effectively treated with autologous T cells expressing an anti-cd19 chimeric antigen receptor. Journal of Clinical Oncology, 33(6), Lee, D. W., Gardner, R., Porter, D. L., Louis, C. U., Ahmed, N., Jensen, M., Grupp, S. A., & Mackall, C. L. (2014). Current concepts in the diagnosis and management of cytokine release syndrome. Blood, 124(2), doi: /blood Tombaugh, T. N., & McIntyre, N. J. (1992). The mini-mental state examination: A comprehensive review. Journal of the American Geriatrics Society, 40(9),
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