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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-003260-28 | EudraCT Number | ||
| 2024-511594-30 | Other Identifier | European Medicines Agency |
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The goal of this clinical study is test how well the study drug, axicabtagene ciloleucel, works in participants with relapsed/refractory follicular lymphoma
Five years after the last study participant is randomized, participants who have received axicabtagene ciloleucel will transition to a separate Long-term Follow-up study (study KT-US-982-5968) to complete the remainder of the 15-year follow-up assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Axicabtagene Ciloleucel | Experimental | Participants will receive cyclophosphamide 500 mg/m^2/day intravenously (IV) and fludarabine 30 mg/m^2/day IV lymphodepleting chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells will be administered. |
|
| Standard of Care Therapy | Active Comparator | Participants will receive the investigator's choice of one of the following therapies/dosing schedules:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Axicabtagene Ciloleucel | Biological | A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) as Assessed by Blinded Central Assessment per Lugano Classification | PFS is defined as the time from randomization to disease progression or death due to any cause. | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as the time from randomization to death from any cause. | Up to 5 years |
| Complete Response (CR) Rate as Assessed by Blinded Central Assessment per Lugano Classification |
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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 |
|---|---|---|---|---|---|---|
| City of Hope (City of Hope National Medical Center, City of Hope Medical Center) | Duarte | California | 91010 | United States | ||
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| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
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| Cyclophosphamide | Drug | Administered intravenously |
|
| Fludarabine | Drug | Administered intravenously |
|
| Lenalidomide | Drug | Administered orally |
|
| Rituximab | Drug | Administered intravenously |
|
| Doxorubicin | Drug | Administered intravenously |
|
| Vincristine | Drug | Administered intravenously |
|
| Prednisone | Drug | Administered orally |
|
| Bendamustine | Drug | Administered intravenously |
|
CR rate is defined as the proportion of participants with best overall response of CR during the study prior to any subsequent off-protocol anti-follicular lymphoma (FL) therapy.
| Up to 5 years |
| Objective Response Rate (ORR) as Assessed by Blinded Central Assessment per Lugano Classification | Objective response rate is defined as the proportion of participants with best overall response of either a complete response or a partial response during the study prior to any subsequent off-protocol anti-FL therapy. | Up to 5 years |
| Duration of Response (DOR) as Assessed by Blinded Central Assessment per Lugano Classification | DOR is defined as the time from first objective response to disease progression or death from any cause. | Up to 5 years |
| Duration of CR as Assessed by Blinded Central Assessment per Lugano Classification | Duration of CR is defined as the time from first CR to disease progression or death from any cause. | Up to 5 years |
| Event Free Survival (EFS) as Assessed by Blinded Central Assessment per Lugano Classification | EFS is defined as the time from randomization to the earliest date of disease progression, the initiation of subsequent off-protocol anti-FL therapy, or death from any cause. | Up to 5 years |
| Time to Next Treatment (TTNT) | TTNT is defined as the time from randomization to the start of subsequent off-protocol anti-lymphoma therapy or death from any cause. | Up to 5 years |
| Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | Randomization up to 5 years plus 30 days |
| Percentage of Participants Experiencing Clinically Significant Changes in Safety Laboratory Values | Randomization up to 5 years plus 30 days |
| Percentage of Participants with Replication-competent Retrovirus in Blood Over time | Up to 5 years |
| Change From Baseline in the Global Health Status Quality of Life Scale of the European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-30 (EORTC QLQ-C30) | The EORTC-QLQ-C30 is a multi-item questionnaire measuring the following content five (5) multi-item functional scales, three (3) multi-item symptom scales, one (1) global health status scale, and one (1) global health-related quality of life (HRQoL) each scale is measured from 0 to 100 after a linear transformation. Higher scores for functioning scales and for the Global Health Status or Global HRQoL scales indicate a higher level of functioning and a better HRQoL respectively, whereas higher scores in symptom scales represent a higher level of symptoms. | Baseline, up to 5 years |
| Change From Baseline in the Physical Functioning Domain of the EORTC QLQ-C30 | The EORTC-QLQ-C30) is a multi-item questionnaire measuring the following content five (5) multi-item functional scales, three (3) multi-item symptom scales, one (1) global health status scale, and one (1) global health-related quality of life (HRQoL) each scale is measured from 0 to 100 after a linear transformation. Higher scores for functioning scales and for the Global Health Status or Global HRQoL scales indicate a higher level of functioning and a better HRQoL respectively, whereas higher scores in symptom scales represent a higher level of symptoms. | Baseline, up to 5 years |
| Change From Baseline in the Global Health Status Quality of Life Scale of the Low Grade Non-Hodgkin Lymphoma-20 (NHL-LG20) | The NHL-LG20 is is a 20-item supplement questionnaire that was specifically developed to assess HRQoL in participants with low-grade non-Hodgkin lymphomas (such as follicular lymphoma). The NHL-LG20 includes multi-item scales of symptom burden, physical condition/fatigue, worries/fears on health and functioning, and emotional impact; and is administered in conjunction with the EORTC QLQ-C30. Each scale is measured from 0 to 100 after a linear transformation. Higher scores for functional scales and for the global health status or global HRQoL scales indicate a higher level of functioning and a better HRQoL, whereas higher scores in symptom scales represent a higher level of symptoms. | Baseline, up to 5 years |
| Change From Baseline in the Physical Functioning Domain of the NHL-LG20 | The NHL-LG20 is is a 20-item supplement questionnaire that was specifically developed to assess HRQoL in participants with low-grade non-Hodgkin lymphomas (such as follicular lymphoma). The NHL-LG20 includes multi-item scales of symptom burden, physical condition/fatigue, worries/fears on health and functioning, and emotional impact; and is administered in conjunction with the EORTC QLQ-C30. Each scale is measured from 0 to 100 after a linear transformation. Higher scores for functional scales and for the global health status or global HRQoL scales indicate a higher level of functioning and a better HRQoL, whereas higher scores in symptom scales represent a higher level of symptoms. | Baseline, up to 5 years |
| Changes From Baseline in the European Quality of Life Five Dimensions Five Levels Scale (EQ-5D-5L) | The EQ-5D-5L questionnaire is a generic measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L comprises 2 components: a questionnaire covering 5 dimensions and a tariff of values based upon direct valuations of health states using a visual analog scale (VAS). Rating gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health. | Baseline, up to 5 years |
| Changes From Baseline in the Visual Analog Scale (VAS) Scores | The EQ-5D-5L VAS is a 20-cm VAS for recording self-rated current HRQoL state and is used to describe the participants health status on the day of the assessment. The EQ-5D-5L VAS score is recorded by each participant for his or her current HRQoL state and scored 0 ("the worst health you can imagine") to 100 ("the best health you can imagine"). Higher scores indicate better health. | Baseline, up to 5 years |
| Stanford Health Care |
| Stanford |
| California |
| 94305 |
| United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| The University of Kansas Hospital | Westwood | Kansas | 66205 | United States |
| University of Maryland Greenebaum Comprehensive Cancer Center | Baltimore | Maryland | 21201 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Novant Health Cancer Institute Hematology - Charlotte | Charlotte | North Carolina | 28204 | United States |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| TriStar Centennial Medical Center - Cell Processing | Nashville | Tennessee | 37203 | United States |
| Henry-Joyce Cancer Clinic | Nashville | Tennessee | 37232 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| Hopital Henri Mondor | Créteil | 94010 | France |
| CHU de Dijon | Dijon | 21079 | France |
| Hôpital Claude Huriez-CHU de Lille | Lille | 59037 | France |
| Institut Paoli-Calmettes | Marseille | 13273 | France |
| Hopital Saint Eloi | Montpellier | 34295 | France |
| Hopital Pitie-Salpetriere | Paris | 75013 | France |
| CHU Bordeaux - Hospital Haut-Leveque - Centre Francois Magendie | Pessac | 33604 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69495 | France |
| CHU de Poitiers | Poitiers | 86021 | France |
| Hopital Pontchaillou - CHU Rennes | Rennes | 35033 | France |
| Centre Henri Becquerel | Rouen | 76038 | France |
| Universitatsmedizin Gottingen | Göttingen | 37075 | Germany |
| Universitatsklinikum Koln Klinik I fur Innere Medizin | Würzburg | 97080 | Germany |
| ASST Papa Giovanni XXIII | Bergamo | 24128 | Italy |
| Azienda Ospedallero-Universitaria di Bologna Policlinico Sant'Orsola-Malpighi | Bologna | 40138 | Italy |
| Fondazione IRCCS - Istituto Nazionale Tumori | Milan | 20100 | Italy |
| Ospedale San Raffaele | Milan | 20132 | Italy |
| Arcispedale Santa Maria Nuova | Reggio Emilia | 42123 | Italy |
| Istituto Clinico Humanitas-IRCCS | Rozzano | 20089 | Italy |
| Hyogo Medical University Hospital | Hyōgo | 663-8501 | Japan |
| University Hospital Kyoto Prefectural University of Medicine | Kyoto | 602-8566, | Japan |
| Tohoku University Hospital | Miyagi | 980-8574 | Japan |
| Okayama University Hospital | Okayama | 700-8558 | Japan |
| Osaka University Hospital | Osaka | 565-0871 | Japan |
| Hospital Universitari Vall d'Hebrón | Barcelona | 08035 | Spain |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Instituto Catalan de Oncologia - Hospital Duran i Reynolds (ICO L'Hospitalet) | Barcelona | 08908 | Spain |
| Hospital General Universitario Gregorio Maranon | Madrid | 28009 | Spain |
| Hospital 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario de Salamanca | Salamanca | 37007 | Spain |
| Hospital Universitario Virgen del Rocio | Seville | 41013 | Spain |
| Hospital Clínico Universitario de Valencia | Valencia | 46010 | Spain |
| University Hospital Birmingham NHS Foundation Trust | Birmingham | B15 2GW | United Kingdom |
| Cambridge University Hospitals NHS Foundation Trust | Cambridge | CB2 2QQ | United Kingdom |
| University College London Hospitals NHS Foundation Trust | London | NW2 2QG | United Kingdom |
| King's College Hospital NHS Foundation Trust | London | SE5 9RS | United Kingdom |
| The Christie NHS Foundation Trust | Manchester | M20 4BX | United Kingdom |
| Oxford University Hospitals NHS Foundation Trust | Oxford | OX3 7LE | United Kingdom |
| The University Hospital Southampton NHS Foundation Trust | Southampton | SO16 6YD | United Kingdom |
| The Royal Marsden NHS Foundation Trust | Sutton | SM2 5PT | United Kingdom |
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| 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 |
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| ID | Term |
|---|---|
| C000629083 | axicabtagene ciloleucel |
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| D000077269 | Lenalidomide |
| D000069283 | Rituximab |
| D004317 | Doxorubicin |
| D014750 | Vincristine |
| D011241 | Prednisone |
| D000069461 | Bendamustine Hydrochloride |
| 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 |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D001562 | Benzimidazoles |
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