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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001912-13 | EudraCT Number | ||
| 2023-505169-10 | Other Identifier | European Medicines Agency |
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The goal of this study is to assess whether axicabtagene ciloleucel improves the clinical outcome in participants with relapsed or refractory indolent non-Hodgkin lymphoma (r/r) iNHL.
After completing at least 60 months (FL participants) or at least 24 months (MZL participants) of assessments in this study since the initial axicabtagene ciloleucel infusion and after agreement by the Sponsor, participants will transition to a long-term follow-up (LTFU) study, KT-US-982-5968 where they will complete the remainder of the 15 year follow-up assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Experimental | Participants with relapsed or refractory (r/r) B-cell indolent non-Hodgkin lymphoma (iNHL) subtype of follicular lymphoma (FL) will receive the following treatment during the study:
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| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Experimental | Participants with r/r B-cell iNHL subtype of marginal zone lymphoma (MZL) will receive the following treatment during the study:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Axicabtagene ciloleucel | Biological | Administered intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR): Percentage of Participants With Objective Response Per the Lugano Classification by Central Assessment | OR:CR (complete metabolic response (CMR)+complete radiological response (CRR))+PR (partial MR response (PMR) +partial RR(PRR)).CMR: score 1(no uptake above background)/2(uptake≤mediastinum)/3(uptake >mediastinum but ≤liver)with/without a residual mass on positron emission tomography 5-point scale;no new lesions,CRR:target nodes/nodal masses regressed to ≤1.5 cm in longest transverse diameter of lesion (LDi);no extralymphatic sites of disease;absent non-measured lesion(NMLs);organ enlargement regress to normal; no new sites;bone marrow normal by morphology.PMR:score 4(uptake moderately>liver)/5(uptake markedly>liver, new lesions) with reduced uptake compared with baseline and residual mass;no new lesions;responding disease at interim/residual disease at end of treatment.PRR:≥50% decrease in sum of product of diameters up to 6 target nodes and extra-nodal sites;absent/normal,regressed,but no increase of NMLs;spleen regressed by>50% in length beyond normal. Percentages were rounded-off. | Up to 85.6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With CR Per the Lugano Classification by Central Assessment | CR is defined in outcome measure (OM)#1. Percentages were rounded-off. | Up to 85.6 months |
| ORR: Percentage of Participants With OR Per the Lugano Classification by Central Assessment Among Participants With 3 or More Lines of Prior Therapy |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Kite Study Director | Kite, A Gilead Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | United States | ||
| USC Norris Comprehensive Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Jacobson CA, Chavez JC, Sehgal AR, et al. Interim analysis of ZUMA-5: A phase II study of axicabtagene ciloleucel (axi-cel) in patients (pts) with relapsed/refractory indolent non-Hodgkin lymphoma (R/R iNHL). Conference Proceedings of the American Society of Clinical Oncology 2020 | ||
| Background | Jacobson CA, Chavez JC, Sehgal AR, et al. Interim analysis of ZUMA-5: A phase II study of axicabtagene ciloleucel (axi-cel) in patients (pts) with relapsed/refractory indolent non-Hodgkin lymphoma (R/R iNHL) [Abstract]. Conference Proceedings of the Society of Hematologic Oncology 2020. | ||
| Background | Jacobson CA, Chavez JC, Sehgal AR, et al. Interim analysis of ZUMA-5: A phase II study of axicabtagene ciloleucel (axi-cel) in patients (pts) with relapsed/refractory indolent non-Hodgkin lymphoma (R/R iNHL) [Abstract]. Clinical Lymphoma, Myeloma and Leukemia 2020;20 (1 Suppl):S278. | ||
| Background | Jacobson C, Chavez JC, Sehgal AR, et al. Primary analysis of Zuma-5: A phase 2 study of axicabtagene ciloleucel (axi-cel) in patients with relapsed/refractory (r/r) indolent non-Hodgkin lymphoma (iNHL). Blood 2020;136 (1 Suppl):40-41. | ||
| Background | Chavez JC, Jacobson CA, Sehgal AR, et al. Retreatment with axicabtagene ciloleucel (axi-cel) in patients with relapsed/refractory indolent non-Hodgkin lymphoma in ZUMA-5. Blood 2020;136 (1 Suppl):34. | ||
| 34895487 |
| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
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Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy#Commitment
18 months after study completion
A secured external environment with username, password, and RSA code.
189 participants were screened. A total of 159 participants were enrolled. However, one participant discontinued the study as the participant did not meet study condition eligibility criteria (was diagnosed with diffuse large B-cell lymphoma (DLBCL)). So, 158 participants were considered in the Full Analysis Set (FAS = all enrolled participants).
Participants were enrolled at study sites in the United States and France.
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| ID | Title | Description |
|---|---|---|
| FG000 | Axicabtagene Ciloleucel (Follicular Lymphoma) | Participants with relapsed or refractory (r/r) B-cell indolent non-Hodgkin lymphoma (iNHL) subtype of follicular lymphoma (FL) received the following treatment during the study:
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| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 29, 2024 | Aug 11, 2025 |
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|
| Cyclophosphamide | Drug | Administered intravenously |
|
| Fludarabine | Drug | Administered intravenously |
|
OR was defined as percentage of participants with CR + PR per the Lugano Classification for participants with 3 or more lines of prior therapy. CR and PR are defined in OM#1. Percentages were rounded-off. |
| Up to 85.6 months |
| Percentage of Participants With CR Per Lugano Classification by Central Assessment Among Participants With 3 or More Lines of Prior Therapy | CR is defined as OM#1. Percentages were rounded-off. | Up to 85.6 months |
| ORR: Percentage of Participants With OR Per the Lugano Classification by Investigator Assessment | OR was defined as percentage of participants with CR + PR per the Lugano Classification. CR and PR are defined in OM#1. Percentages were rounded-off. | Up to 85.6 months |
| Percentage of Participants With Best Overall Response (BOR) Per the Lugano Classification by Central Assessment | BOR was defined as percentage of participants with CR, PR, stable disease(SD), disease progression(PD), non-evaluable(NE), undefined/no disease or not done as best response to treatment by the Lugano Classification. CR and PR defined in OM#1. SD/no metabolic response(NMR):score 4(uptake moderately greater than (>) liver) or 5(uptake markedly>liver and/ or new lesions) with no significant change in fluorodeoxyglucose(FDG) uptake compared to baseline(screening), at interim time point or end of treatment; no new sites of disease should be observed. PD:score 4(uptake moderately>liver) or 5(uptake markedly>liver and/or new lesions) with an increase in intensity of uptake from baseline; new FDG-avid foci consistent with lymphoma at interim or end of treatment assessment; new FDG-avid foci consistent with lymphoma rather than another etiology (eg, infection, inflammation); new or recurrent FDG-avid foci in bone marrow. Not done:no assessment at time of analysis. Percentages were rounded off. | Up to 85.6 months |
| Percentage of Participants With BOR Per the Lugano Classification by Investigator Assessment | BOR was defined as the percentage of participants with CR, PR, stable disease (SD), PD, NE (not evaluable) or not done as best response to treatment by the Lugano Classification. CR and PR are defined in OM#1. SD, PD and not done are defined in OM#6. Percentages were rounded off. | Up to 85.6 months |
| Duration of Response (DOR) by Central Assessment | DOR was defined only for participants who experienced an OR (CR and PR) and was the time from the first objective response to disease progression or disease-related death, whichever came first. CR and PR are defined in OM#1. PD is defined in OM#6. Kaplan-Meier (KM) estimates were used for analysis. | Up to 85.6 months |
| DOR by Investigator Assessment | DOR was defined only for participants who experienced an OR (CR and PR) and was the time from the first objective response to disease progression or disease-related death, whichever came first. Definitions for CR, PR are defined in OM#1. PD is defined in OM#6. KM estimates were used for analysis. | Up to 85.6 months |
| Progression-free Survival (PFS) Per Lugano Classification by Central Assessment | PFS was defined as the time from the axicabtagene ciloleucel infusion date to the date of disease progression per Lugano classification or death from any cause. PD is defined in OM 6. KM estimates were used for analysis. | Up to 85.6 months |
| PFS Per Lugano Classification by Investigator Assessment | PFS was defined as the time from the axicabtagene ciloleucel infusion date to the date of disease progression per Lugano classification or death from any cause. PD is defined in OM 6. KM estimates were used for analysis. | Up to 85.6 months |
| Overall Survival (OS) | OS was defined as the time from axicabtagene ciloleucel infusion to the date of death. KM estimates were used for analysis. | Up to 85.6 |
| Time to Next Therapy | Time from axicabtagene ciloleucel infusion date to the start of the subsequent new lymphoma therapy or death from any cause. KM estimates were used for analysis. | Up to 85.6 months |
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | TEAE was defined as any adverse event with onset on or after the start of treatment. Percentages were rounded-off. | Up to 85.6 months |
| Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher | Percentages were rounded-off. | Up to 85.6 months |
| Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher | Percentages were rounded-off. | Up to 85.6 months |
| Percentage of Participants With Antibodies Against Anti-CD19 Chimeric Antigen Receptor (CAR) T Cells | Up to 85.6 months |
| Levels of Anti-CD19 CAR T Cells in Blood | Day 7, Week 2, Week 4, Month 3, Month 6, Month 12, Month 18 and Month 24 |
| Levels of Serum C-Reactive Protein (CRP) | Baseline (at enrollment), predose: Day 0, postdose: Day 3, Day 7, Week 2, Week 4 |
| Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum analytes: Serum Ferritin, Serum intercellular adhesion molecule-1 (ICAM-1), Serum interleukin-2 receptor (IL-2 R) alpha, Serum Perforin and Serum vascular cell adhesion molecule-1 (VCAM-1). | Baseline (at enrollment), predose: Day 0, postdose: Day 3, Day 7, Week 2, Week 4 |
| Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum analytes: Serum CXCL10, Serum Granzyme B, Serum interferon (IFN)-gamma, Serum IL-1 receptor antagonist (RA), Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum tumor necrosis factor (TNF) Alpha. | Baseline (at enrollment), predose: Day 0, postdose: Day 3, Day 7, Week 2, Week 4 |
| Los Angeles |
| California |
| 90033 |
| United States |
| University of California Los Angeles | Los Angeles | California | 90095 | United States |
| Georgetown Lombardi Comprehensive Cancer Center | Washington D.C. | District of Columbia | 20007 | United States |
| University of Miami Hospital and Clinics | Miami | Florida | 33136 | United States |
| H Lee Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Hackensack University Medical Center - John Theurer Cancer Center | Hackensack | New Jersey | 07601 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| University of Rochester Medical Center (URMC) | Rochester | New York | 14642 | United States |
| Ohio State University Medical Center | Cleveland | Ohio | 44106 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | United States |
| Centre Hospitalier Régional Universitaire de Lille | Lille | 59037 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69495 | France |
| Background |
| Jacobson CA, Chavez JC, Sehgal AR, William BM, Munoz J, Salles G, Munshi PN, Casulo C, Maloney DG, de Vos S, Reshef R, Leslie LA, Yakoub-Agha I, Oluwole OO, Fung HCH, Rosenblatt J, Rossi JM, Goyal L, Plaks V, Yang Y, Vezan R, Avanzi MP, Neelapu SS. Axicabtagene ciloleucel in relapsed or refractory indolent non-Hodgkin lymphoma (ZUMA-5): a single-arm, multicentre, phase 2 trial. Lancet Oncol. 2022 Jan;23(1):91-103. doi: 10.1016/S1470-2045(21)00591-X. Epub 2021 Dec 8. |
| Background | Chavez JC, Jacobson CA, Sehgal A, et al. Updated outcomes with axicabtagene ciloleucel (axi-cel) retreatment (reTx) in patients (pts) with relapsed/refractory (R/R) indolent non-Hodgkin lymphoma (iNHL) in ZUMA-5. J Clin Oncol 2021;39 (15 suppl):7548. |
| Background | Chavez JC, Jacobson CA, Sehgal AR, et al. Retreatment with axicabtagene ciloleucel (axi-cel) in patients (pts) with relapsed/refractory (r/r) indolent non-hodgkin lymphoma (iNHL) in ZUMA-5 [Oral abstract]. Transplantation and Cellular Therapy 2021;27 (Issue 3, Supplement):S43, ISSN 2666-6367 |
| Background | Chavez JC, Jacobson CA, Sehgal AR, et al. Retreatment with axicabtagene ciloleucel in patients with relapsed/refractory indolent non-hodgkin lymphoma in ZUMA-5 [Oral abstract]. British Journal of Heamatology 2021;193. Abstract BSH2021-PO-149. |
| Background | Chavez JC, Jacobson CA, Sehgal AR, et al. Updated outcomes with axicabtagene ciloleucel (axi-cel) retreatment in patients with relapsed/refractory indolent non-Hodgkin lymphoma in ZUMA-5 [Abstract]. European Hematology Association (EHA) 2021:325549. |
| Background | Ghione P, Patel A, Bobillo S, et al. A comparison of clinical outcomes from Zuma-5 (axicabtagene ciloleucel) and the international scholar-5 external control cohort in relapsed/refractory follicular lymphoma (R/R/FL) [Abstract]. European Hematology Association (EHA) Virtual; 2021 09-17 June. |
| 36263843 | Background | Ghione P, Palomba ML, Ghesquieres H, Bobillo S, Patel AR, Nahas M, Kanters S, Deighton K, Hatswell A, Ma L, Limbrick-Oldfield EH, Snider JT, Wade SW, Riberio MT, Radford J, Beygi S, Gribben J. Treatment patterns and outcomes in relapsed/refractory follicular lymphoma: results from the international SCHOLAR-5 study. Haematologica. 2023 Mar 1;108(3):822-832. doi: 10.3324/haematol.2022.281421. |
| Background | Jacobson CA, Chavez JC, Sehgal A, et al. Outcomes in ZUMA-5 with axicabtagene ciloleucel (axi-cel) in patients (pts) with relapsed/refractory (R/R) indolent non-Hodgkin lymphoma (iNHL) who had the high-risk feature of progression within 24 months from initiation of first anti-CD20-containing chemoimmunotherapy (POD24). J Clin Oncol 2021a;39 (15 Suppl):7515 |
| Background | Jacobson CA, Chavez JC, Sehgal AR, et al. Outcomes in Zuma-5 with axicabtagene ciloleucel in patients with relapsed/refractory indolent non-Hodgkin lymphoma who had the high-risk feature of early progression after first chemoimmunotherapy [Abstract]. European Hematology Association (EHA) Virtual; 2021b 09-17 June. |
| Background | Jacobson CA, Chavez JC, Sehgal AR, et al. Primary analysis of ZUMA-5: A phase 2 study of axicabtagene ciloleucel (axi-cel) in patients (pts) with relapsed/refractory (r/r) indolent non-Hodgkin lymphoma (iNHL) [Oral abstract 69]. Transplantation and Cellular Therapy 2021; 27 (Issue 3, Supplement): S67-S68, ISSN 2666-6367 |
| Background | Jacobson CA, Chavez JC, Sehgal AR, et al. Primary analysis of ZUMA-5: A phase 2 study of axicabtagene ciloleucel in patients with relapsed/refractory indolent non-hodgkin lymphoma [Oral abstract]. British Journal of Heamatology 2021, BSH2021-OR-036. |
| Background | Neelapu SS, Chavez JC, Sehgal AR, et al. Long-term follow-up analysis of ZUMA-5: A phase 2 study of axicabtagene ciloleucel (axi-cel) in patients with relapsed/refractory (R/R) indolent non-Hodgkin lymphoma (iNHL) [Abstract 93]. Blood 2021;138 (1 Suppl) |
| Background | Plaks V, Chou J, Goyal L, et al. Axicabtagene ciloleucel (axi-cel) product attributes and immune biomarkers associated with clinical outcomes in patients (pts) with relapsed/refractory R/R) indolent non-Hodgkin lymphoma (iNHL) in ZUMA-5 [Abstract CT036]. Cancer Res 2021;81 (13 Suppl). |
| 36690960 | Background | Kanters S, Ball G, Kahl B, Wiesinger A, Limbrick-Oldfield EH, Sudhindra A, Snider JT, Patel AR. Clinical outcomes in patients relapsed/refractory after >/=2 prior lines of therapy for follicular lymphoma: a systematic literature review and meta-analysis. BMC Cancer. 2023 Jan 23;23(1):74. doi: 10.1186/s12885-023-10546-6. |
| Background | Palomba ML, Ghione P, Patel AR, et al. A comparison of clinical outcomes from updated ZUMA-5 (axicabtagene ciloleucel) and the international scholar-5 external control cohort in relapsed/refractory follicular lymphoma (R/R FL) [Abstract PB1571]. Blood 2021;138 (1 Suppl):3543. |
| Background | Neelapu SS, Chavez JC, Sehgal AR, et al. Long-term follow-up analysis of Zuma-5: A phase 2 study of axicabtagene ciloleucel (axi-cel) in patients (pts) with relapsed/refractory (r/r) indolent non-Hodgkin lymphoma (iNHL) [Abstract 75]. Transplantation and Cellular Therapy 2022;28 (Issue 3, Supplement):S64-S65, ISSN 2666-6367. |
| Background | Neelapu SS, Chavez JC, Sehgal AR, et al. Long-term analysis of ZUMA-5 phase 2 study of axicabtagene ciloleucel in patients with indolent non-Hodgkin lymphoma [Oral presentation O3-5]. 2022 Japanese Society of Medical Oncology - 19th Scientific Meeting |
| 35514320 | Background | Hatswell AJ, Deighton K, Snider JT, Brookhart MA, Faghmous I, Patel AR. Approaches to Selecting "Time Zero" in External Control Arms with Multiple Potential Entry Points: A Simulation Study of 8 Approaches. Med Decis Making. 2022 Oct;42(7):893-905. doi: 10.1177/0272989X221096070. Epub 2022 May 6. |
| 35679476 | Background | Ghione P, Palomba ML, Patel AR, Bobillo S, Deighton K, Jacobson CA, Nahas M, Hatswell AJ, Jung AS, Kanters S, Snider JT, Neelapu SS, Ribeiro MT, Brookhart MA, Ghesquieres H, Radford J, Gribben JG. Comparative effectiveness of ZUMA-5 (axi-cel) vs SCHOLAR-5 external control in relapsed/refractory follicular lymphoma. Blood. 2022 Aug 25;140(8):851-860. doi: 10.1182/blood.2021014375. |
| Background | Neelapu SS, Chavez JC, Sehgal AR, et al. 3-Year follow-up analysis of ZUMA-5: A phase 2 study of axicabtagene ciloleucel (axi-cel) in patients with relapsed/refractory (r/r) indolent non-Hodgkin lymphoma (iNHL). Blood 2022;140 (1 Suppl):10380-10383. |
| 38641058 | Background | Oluwole OO, Ray MD, Rosettie KL, Ball G, Jacob J, Bilir SP, Patel AR, Jacobson CA. Cost-Effectiveness of Axicabtagene Ciloleucel for Adult Patients With Relapsed or Refractory Follicular Lymphoma in the United States. Value Health. 2024 Aug;27(8):1030-1038. doi: 10.1016/j.jval.2024.04.003. Epub 2024 Apr 17. |
| Background | Ghione P, Palomba ML, Ray MD, et al. A 3-year follow-up comparison of clinical outcomes from Zuma-5 (axicabtagene ciloleucel) and the international Scholar-5 external control cohort in relapsed/refractory follicular lymphoma (R/R FL). Blood 2022;140 (1 Suppl):4676-4677. |
| Background | Neelapu SS, Chavez JC, Sehgal AR, et al. 3-Year follow-up analysis of Zuma-5: A phase 2 study of axicabtagene ciloleucel (axi-cel) in patients (pts) with relapsed/refractory (r/r) indolent non-Hodgkin lymphoma (iNHL) [Abstract 500]. Transplantation and Cellular Therapy 2023;29 (Issue 2, Supplement):S374, ISSN 2666-6367 |
| 36723678 | Background | Palomba ML, Ghione P, Patel AR, Nahas M, Beygi S, Hatswell AJ, Kanters S, Limbrick-Oldfield EH, Wade SW, Ray MD, Owen J, Neelapu SS, Gribben J, Radford J, Bobillo S. A 24-month updated analysis of the comparative effectiveness of ZUMA-5 (axi-cel) vs. SCHOLAR-5 external control in relapsed/refractory follicular lymphoma. Expert Rev Anticancer Ther. 2023 Feb;23(2):199-206. doi: 10.1080/14737140.2023.2171994. Epub 2023 Feb 10. |
| Background | Patel AR, Limbrick-Oldfield EH, Kanters S, et al., The prognostic value of progressing within 24 months of frontline chemoimmunotherapy (POD24) in relapsed/refractory (R/R) follicular lymphoma (FL)-a SCHOLAR-5 analysis. Hematological Oncology 2023;41:376-377. |
| Background | Ray MD, Kanters S, Beygi S, et al. Matching-adjusted indirect comparison of axicabtagene ciloleucel versus mosunetuzumab in relapsed/refractory follicular lymphoma patients after 2 prior systemic treatments. Hematological Oncology 2023;41:522-523 |
| Background | Neelapu SS, Chavez JC, Sehgal AR, et al. Axicabtagene ciloleucel (axi-cel) in patients with relapsed/refractory indolent non-Hodgkin lymphoma: 4-year follow-up from the phase 2 ZUMA-5 trial. Blood 2023;142 (1 Suppl):4868. |
| Background | Bachy E, Neelapu SS, Chavez JC, et al. A retrospective intra-patient analysis from ZUMA-5: Axicabtagene ciloleucel (axi-cel) compared with prior standard-of-care therapy in patients with relapsed/refractory follicular lymphoma. Blood 2023;142 (1 Suppl):4865. |
| Background | Gribben JG, Ghione P, Palomba ML, et al. An updated comparison of clinical outcomes from 4-year follow-up of Zuma-5 (axicabtagene ciloleucel) and the international Scholar-5 external control cohort in relapsed/refractory follicular lymphoma. Blood 2023;142 (1 Suppl):4869. |
| Background | Eklund O, Hedlöf Kanje V, Doble B, et al. EE536 Cost-effectiveness of axicabtagene ciloleucel (axi-cel) vs standard of care for adult patients with relapsed or refractory follicular lymphoma as 4TH or later line treatment in Sweden. Value in Health 2023;26 (Issue 12, Supplement):S155, ISSN 1098-3015. |
| 38365528 | Background | Ghione P, Palomba ML, Ray MD, Limbrick-Oldfield EH, Owen J, Kanters S, Bobillo S, Ribiero MT, Jacobson CA, Neelapu SS, Ghesquieres H, Nahas M, Beygi S, Patel AR, Gribben JG. A Comparison of 3-Year Follow-up of ZUMA-5 (Axicabtagene Ciloleucel) With SCHOLAR-5 in Relapsed/Refractory Follicular Lymphoma. Clin Lymphoma Myeloma Leuk. 2024 May;24(5):e191-e195.e6. doi: 10.1016/j.clml.2024.01.011. Epub 2024 Jan 24. |
| 37879047 | Background | Neelapu SS, Chavez JC, Sehgal AR, Epperla N, Ulrickson M, Bachy E, Munshi PN, Casulo C, Maloney DG, de Vos S, Reshef R, Leslie LA, Oluwole OO, Yakoub-Agha I, Khanal R, Rosenblatt J, Korn R, Peng W, Lui C, Wulff J, Shen R, Poddar S, Jung AS, Miao H, Beygi S, Jacobson CA. Three-year follow-up analysis of axicabtagene ciloleucel in relapsed/refractory indolent non-Hodgkin lymphoma (ZUMA-5). Blood. 2024 Feb 8;143(6):496-506. doi: 10.1182/blood.2023021243. |
| 38855109 | Background | Oluwole OO, Ray MD, Zur RM, Ferrufino CP, Doble B, Patel AR, Bilir SP. Cost-effectiveness of treating relapsed or refractory 3L+ follicular lymphoma with axicabtagene ciloleucel vs mosunetuzumab in the United States. Front Immunol. 2024 May 24;15:1393939. doi: 10.3389/fimmu.2024.1393939. eCollection 2024. |
| 38901633 | Background | Ray MD, Kanters S, Beygi S, Best T, Wulff J, Limbrick-Oldfield E, Patel AR, Oluwole OO. Matching-Adjusted Indirect Comparisons of Axicabtagene Ciloleucel to Mosunetuzumab for the Treatment of Relapsed/Refractory Follicular Lymphoma. Transplant Cell Ther. 2024 Sep;30(9):885.e1-885.e11. doi: 10.1016/j.jtct.2024.06.016. Epub 2024 Jun 19. |
| Background | Neelapu SS, Chavez JC, Sehgal AR, et al. 5-year follow-up analysis from ZUMA-5: A phase 2 trial of axicabtagene ciloleucel (axi-cel) in patients with relapsed/refractory indolent non-Hodgkin lymphoma. Blood 2024;144 (1 Suppl):864. |
| Background | Poddar S, Yan J, Tiwari G, et al. Impact of inflammation, tumor and product attributes on clinical outcomes in patients with relapsed/refractory follicular lymphoma treated with axicabtagene ciloleucel. Blood 2024;144 (1 Suppl):4368 |
| 39917356 | Background | Limbrick-Oldfield EH, Kanters S, Ray MD, Best T, Palivela M, Beygi S, Patel AR, Gribben JG, Ghione P. The prognostic value of POD24 in relapsed/refractory follicular lymphoma-A SCHOLAR-5 analysis. EJHaem. 2025 Feb 6;6(1):e1104. doi: 10.1002/jha2.1104. eCollection 2025 Feb. |
| 41100801 | Derived | Neelapu SS, Chavez JC, Sehgal AR, Epperla N, Ulrickson ML, Bachy E, Munshi PN, Casulo C, Maloney DG, de Vos S, Reshef R, Leslie LA, Oluwole OO, Yakoub-Agha I, Khanal R, Rosenblatt JD, Wulff J, Shen RR, Zhang W, Poddar S, Miao H, Nikolajeva O, Jacobson CA. Five-Year Follow-Up Analysis of ZUMA-5: Axicabtagene Ciloleucel in Relapsed/Refractory Indolent Non-Hodgkin Lymphoma. J Clin Oncol. 2025 Nov 20;43(33):3573-3577. doi: 10.1200/JCO-25-00668. Epub 2025 Oct 16. |
| 40536814 | Derived | Poddar S, Yan J, Tiwari G, Rinchai D, Budka J, Zhang W, Peng W, Salunkhe S, Davis M, Song Q, Beygi S, Miao H, Mattie M, Shen RS, Jacobson CA, Bedognetti D, Filosto S, Neelapu SS. Clinical, tumor, and product features associated with outcomes after axicabtagene ciloleucel therapy in follicular lymphoma. J Clin Invest. 2025 Aug 15;135(16):e181893. doi: 10.1172/JCI181893. eCollection 2025 Aug 15. |
| 39240498 | Derived | Chartier M, Filosto S, Peyret T, Chiney M, Milletti F, Budka J, Ndi A, Dong J, Vardhanabhuti S, Mao D, Duffull S, Dodds M, Shen R. Investigating the Influence of Covariates on Axicabtagene Ciloleucel (axi-cel) Kinetics in Patients with Non-Hodgkin's Lymphoma. Clin Pharmacokinet. 2024 Sep;63(9):1283-1299. doi: 10.1007/s40262-024-01413-z. Epub 2024 Sep 6. |
| FG001 | Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Participants with r/r B-cell iNHL subtype of marginal zone lymphoma (MZL) received the following treatment during the study:
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| COMPLETED |
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| NOT COMPLETED |
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The Safety Analysis Set was defined as all participants treated with any dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Axicabtagene Ciloleucel (Follicular Lymphoma) | Participants with relapsed or refractory (r/r) B-cell indolent non-Hodgkin lymphoma (iNHL) subtype of follicular lymphoma (FL) received the following treatment during the study:
|
| BG001 | Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Participants with r/r B-cell iNHL subtype of marginal zone lymphoma (MZL) received the following treatment during the study:
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| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants | No |
| |||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Response Rate (ORR): Percentage of Participants With Objective Response Per the Lugano Classification by Central Assessment | OR:CR (complete metabolic response (CMR)+complete radiological response (CRR))+PR (partial MR response (PMR) +partial RR(PRR)).CMR: score 1(no uptake above background)/2(uptake≤mediastinum)/3(uptake >mediastinum but ≤liver)with/without a residual mass on positron emission tomography 5-point scale;no new lesions,CRR:target nodes/nodal masses regressed to ≤1.5 cm in longest transverse diameter of lesion (LDi);no extralymphatic sites of disease;absent non-measured lesion(NMLs);organ enlargement regress to normal; no new sites;bone marrow normal by morphology.PMR:score 4(uptake moderately>liver)/5(uptake markedly>liver, new lesions) with reduced uptake compared with baseline and residual mass;no new lesions;responding disease at interim/residual disease at end of treatment.PRR:≥50% decrease in sum of product of diameters up to 6 target nodes and extra-nodal sites;absent/normal,regressed,but no increase of NMLs;spleen regressed by>50% in length beyond normal. Percentages were rounded-off. | Participants in the Full Analysis Set with available data were analyzed. Full Analysis Set consisted of all enrolled participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 85.6 months |
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| Secondary | Percentage of Participants With CR Per the Lugano Classification by Central Assessment | CR is defined in outcome measure (OM)#1. Percentages were rounded-off. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 85.6 months |
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| Secondary | ORR: Percentage of Participants With OR Per the Lugano Classification by Central Assessment Among Participants With 3 or More Lines of Prior Therapy | OR was defined as percentage of participants with CR + PR per the Lugano Classification for participants with 3 or more lines of prior therapy. CR and PR are defined in OM#1. Percentages were rounded-off. | Participants with 3 or more lines of prior therapy in the Full Analysis Set with available data were analyzed | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 85.6 months |
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| Secondary | Percentage of Participants With CR Per Lugano Classification by Central Assessment Among Participants With 3 or More Lines of Prior Therapy | CR is defined as OM#1. Percentages were rounded-off. | Participants with 3 or more lines of prior therapy in the Full Analysis Set with available data were analyzed | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 85.6 months |
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| Secondary | ORR: Percentage of Participants With OR Per the Lugano Classification by Investigator Assessment | OR was defined as percentage of participants with CR + PR per the Lugano Classification. CR and PR are defined in OM#1. Percentages were rounded-off. | Participants in the Full Analysis Set were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 85.6 months |
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| Secondary | Percentage of Participants With Best Overall Response (BOR) Per the Lugano Classification by Central Assessment | BOR was defined as percentage of participants with CR, PR, stable disease(SD), disease progression(PD), non-evaluable(NE), undefined/no disease or not done as best response to treatment by the Lugano Classification. CR and PR defined in OM#1. SD/no metabolic response(NMR):score 4(uptake moderately greater than (>) liver) or 5(uptake markedly>liver and/ or new lesions) with no significant change in fluorodeoxyglucose(FDG) uptake compared to baseline(screening), at interim time point or end of treatment; no new sites of disease should be observed. PD:score 4(uptake moderately>liver) or 5(uptake markedly>liver and/or new lesions) with an increase in intensity of uptake from baseline; new FDG-avid foci consistent with lymphoma at interim or end of treatment assessment; new FDG-avid foci consistent with lymphoma rather than another etiology (eg, infection, inflammation); new or recurrent FDG-avid foci in bone marrow. Not done:no assessment at time of analysis. Percentages were rounded off. | Participants in the Full Analysis Set with available data were analyzed | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 85.6 months |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With BOR Per the Lugano Classification by Investigator Assessment | BOR was defined as the percentage of participants with CR, PR, stable disease (SD), PD, NE (not evaluable) or not done as best response to treatment by the Lugano Classification. CR and PR are defined in OM#1. SD, PD and not done are defined in OM#6. Percentages were rounded off. | Participants in the Full Analysis Set were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 85.6 months |
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| Secondary | Duration of Response (DOR) by Central Assessment | DOR was defined only for participants who experienced an OR (CR and PR) and was the time from the first objective response to disease progression or disease-related death, whichever came first. CR and PR are defined in OM#1. PD is defined in OM#6. Kaplan-Meier (KM) estimates were used for analysis. | Participants with OR in the Full Analysis Set with available data were analyzed | Posted | Median | 95% Confidence Interval | months | Up to 85.6 months |
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| Secondary | DOR by Investigator Assessment | DOR was defined only for participants who experienced an OR (CR and PR) and was the time from the first objective response to disease progression or disease-related death, whichever came first. Definitions for CR, PR are defined in OM#1. PD is defined in OM#6. KM estimates were used for analysis. | Participants with OR in Full Analysis Set were analyzed. | Posted | Median | 95% Confidence Interval | months | Up to 85.6 months |
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| Secondary | Progression-free Survival (PFS) Per Lugano Classification by Central Assessment | PFS was defined as the time from the axicabtagene ciloleucel infusion date to the date of disease progression per Lugano classification or death from any cause. PD is defined in OM 6. KM estimates were used for analysis. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Median | 95% Confidence Interval | months | Up to 85.6 months |
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| Secondary | PFS Per Lugano Classification by Investigator Assessment | PFS was defined as the time from the axicabtagene ciloleucel infusion date to the date of disease progression per Lugano classification or death from any cause. PD is defined in OM 6. KM estimates were used for analysis. | Participants in Full Analysis Set were analyzed. | Posted | Median | 95% Confidence Interval | months | Up to 85.6 months |
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| Secondary | Overall Survival (OS) | OS was defined as the time from axicabtagene ciloleucel infusion to the date of death. KM estimates were used for analysis. | Participants in the Full Analysis Set were analyzed. | Posted | Median | 95% Confidence Interval | months | Up to 85.6 |
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| Secondary | Time to Next Therapy | Time from axicabtagene ciloleucel infusion date to the start of the subsequent new lymphoma therapy or death from any cause. KM estimates were used for analysis. | Participants in the Full Analysis Set were analyzed. | Posted | Median | 95% Confidence Interval | months | Up to 85.6 months |
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| Secondary | Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | TEAE was defined as any adverse event with onset on or after the start of treatment. Percentages were rounded-off. | Participants in the Safety Analysis Set were analyzed. | Posted | Number | percentage of participants | Up to 85.6 months |
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| Secondary | Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher | Percentages were rounded-off. | Participants in the Safety Analysis Set were analyzed. | Posted | Number | percentage of participants | Up to 85.6 months |
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| Secondary | Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher | Percentages were rounded-off. | Participants in the Safety Analysis Set were analyzed. | Posted | Number | percentage of participants | Up to 85.6 months |
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| Secondary | Percentage of Participants With Antibodies Against Anti-CD19 Chimeric Antigen Receptor (CAR) T Cells | Participants from the Safety Analysis Set were analyzed. | Posted | Number | percentage of participants | Up to 85.6 months |
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| Secondary | Levels of Anti-CD19 CAR T Cells in Blood | Participants in the Safety Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | cells/μL | Day 7, Week 2, Week 4, Month 3, Month 6, Month 12, Month 18 and Month 24 |
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| Secondary | Levels of Serum C-Reactive Protein (CRP) | Participants in the Safety Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | mg/L | Baseline (at enrollment), predose: Day 0, postdose: Day 3, Day 7, Week 2, Week 4 |
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| Secondary | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum analytes: Serum Ferritin, Serum intercellular adhesion molecule-1 (ICAM-1), Serum interleukin-2 receptor (IL-2 R) alpha, Serum Perforin and Serum vascular cell adhesion molecule-1 (VCAM-1). | Participants in the Safety Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | ng/L | Baseline (at enrollment), predose: Day 0, postdose: Day 3, Day 7, Week 2, Week 4 |
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| Secondary | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum analytes: Serum CXCL10, Serum Granzyme B, Serum interferon (IFN)-gamma, Serum IL-1 receptor antagonist (RA), Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum tumor necrosis factor (TNF) Alpha. | Participants in the Safety Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | pg/mL | Baseline (at enrollment), predose: Day 0, postdose: Day 3, Day 7, Week 2, Week 4 |
|
Up to 85.6 months
All-cause mortality included Full Analysis Set, that included all enrolled participants.
Adverse events Safety Analysis Set, that included all participants treated with any dose of study drug.
Retreatment arms included the Safety-Retreatment Analysis Set, that included all participants with re-treatment of Axicabtagene Ciloleucel from Safety Analysis Set.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Axicabtagene Ciloleucel: Follicular Lymphoma | Participants with r/r B-cell iNHL subtype of FL received the following treatment during the study:
| 36 | 127 | 65 | 124 | 123 | 124 |
| EG001 | Axicabtagene Ciloleucel: Marginal Zone Lymphoma | Participants with r/r B-cell iNHL subtype of MZL received the following treatment during the study:
| 8 | 31 | 19 | 28 | 28 | 28 |
| EG002 | Axicabtagene Ciloleucel: Retreatment (FL) | Participants with r/r iNHL subtype of FL who achieved a response of PR or better at the 3-month disease assessment, but subsequently experienced disease progression, received a second course of conditioning chemotherapy and IV infusion of 2 × 10^6 anti-CD19 CAR transduced autologous T, once at any time during the study. | 5 | 14 | 5 | 14 | 13 | 14 |
| EG003 | Axicabtagene Ciloleucel: Retreatment (MZL) | Participants with r/r iNHL subtype of MZL who achieved a response of PR or better at the 3-month disease assessment, but subsequently experienced disease progression, received a second course of conditioning chemotherapy and IV infusion of 2 × 10^6 anti-CD19 CAR transduced autologous T, once at any time during the study. | 0 | 2 | 1 | 2 | 2 | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
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| Lymph node pain | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
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| Pancytopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Stress cardiomyopathy | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Blindness | Eye disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Diverticular perforation | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Retroperitoneal haemorrhage | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Multiple organ dysfunction syndrome | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Bacterial infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Coccidioidomycosis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Covid-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Covid-19 pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Cytomegalovirus infection reactivation | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Escherichia infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Kidney infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Lymph gland infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Mycobacterium kansasii infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Parainfluenzae virus infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia streptococcal | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Progressive multifocal leukoencephalopathy | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Prostate infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Systemic candida | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Tracheal obstruction | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood fibrinogen decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Clostridium test positive | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Haptoglobin decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Myeloblast count increased | Investigations | MedDRA 27.1 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Respiratory syncytial virus test positive | Investigations | MedDRA 27.1 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Sacroiliitis | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Acute bilineal leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Ductal adenocarcinoma of pancreas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Follicular lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Malignant anorectal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Aura | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Immune effector cell-associated neurotoxicity syndrome | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Speech disorder | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Nephrotic syndrome | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Stevens-Johnson syndrome | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Aortic dissection | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Catheter site pruritus | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Coronavirus infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Administration related reaction | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood fibrinogen decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Immune effector cell-associated neurotoxicity syndrome | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Parosmia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Angiopathy | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information | Kite, A Gilead Company | 844-454-5483 (1-844-454-KITE) | medinfo@kitepharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 3, 2020 | Aug 11, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016393 | Lymphoma, B-Cell |
Not provided
Not provided
| ID | Term |
|---|---|
| C000629083 | axicabtagene ciloleucel |
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| Other or More Than One Race |
|
| Asian |
|
| France |
|
| Participants |
|
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| Participants |
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| OG001 | Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Participants with r/r B-cell iNHL subtype of MZL received the following treatment during the study:
|
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