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临床试验/NCT05371093
NCT05371093进行中（未招募）3 期

A Phase 3 Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Follicular Lymphoma

Kite, A Gilead Company52 个研究点 分布在 7 个国家目标入组 231 人开始时间: 2022年9月22日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
进行中（未招募）
入组人数
231
试验地点
52
主要终点
Progression-free Survival (PFS) as Assessed by Blinded Central Assessment per Lugano Classification
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The goal of this clinical study is test how well the study drug, axicabtagene ciloleucel, works in participants with relapsed/refractory follicular lymphoma

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Histologically-confirmed follicular lymphoma (FL) (Grade 1, 2, or 3a)
  • •Relapsed/refractory (R/r) disease after first-line chemoimmunotherapy and high-risk disease with relapse or progression within 24 months of the initial course of chemoimmunotherapy (ie, POD24), Or r/r disease after ≥ 2 prior systemic lines of therapy
  • •Clinical indication for treatment.
  • •At least 1 measurable lesion per the Lugano Classification {Cheson 2014}
  • •Adequate renal, hepatic, pulmonary, and cardiac function

排除标准

  • •Presence of large B cell lymphoma or transformed FL
  • •Small lymphocytic lymphoma
  • •Lymphoplasmacytic lymphoma
  • •Full-thickness involvement of the gastric wall by lymphoma
  • •FL Grade 3b
  • •Prior CD19-targeted therapy
  • •Prior CAR therapy or other genetically modified T-cell therapy
  • •Uncontrolled fungal, bacterial, viral, or other infection
  • •Active Infection with human immunodeficiency virus, hepatitis B virus or hepatitis C virus
  • •History or presence of a clincially significant central nervous system (CNS) disorder.
  • •History of autoimmune disease
  • •Known history or CNS lymphoma involvement
  • •Cardiac lymphoma involvement
  • •History of clinically significant cardiac disease 6 months before randomization
  • •Neuropathy greater than grade 2
  • •Females who are pregnant or breastfeeding
  • •Individuals of both genders who are not willing to practice birth control
  • •Presence of any indwelling line or drain (eg, percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, G/J-tube, pleural/peritoneal/pericardial catheter, or Ommaya reservoirs). Dedicated central venous access catheters such as Port-a-Cath or Hickman catheter are permitted.
  • •Note: Other protocol defined Inclusion/Exclusion criteria may apply.

研究组 & 干预措施

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.

干预措施: Axicabtagene Ciloleucel (Biological)

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.

干预措施: Cyclophosphamide (Drug)

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.

干预措施: Fludarabine (Drug)

Standard of Care Therapy

Active Comparator

Participants will receive the investigator's choice of one of the following therapies/dosing schedules:

  • Rituximab plus lenalidomide (R^2) for 12 cycles (28-day cycle)

  • Cycle 1: lenalidomide 20 mg/day on Day 1 through Day 21; rituximab 375 mg/m^2 on Day 1, Day 8, Day 15, and Day 22

  • Cycle 2 through Cycle 5: lenalidomide 20 mg/day on Day 1 through Day 21; Rituximab 375 mg/m2 on Day 1

  • Cycle 6 through Cycle 12: lenalidomide 20 mg/day on Day 1 through Day 21

  • Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) for 6 cycles (21-day cycle)

  • rituximab 375 mg/m^2 on Day 1

  • cyclophosphamide 750 mg/m^2 on Day 1

  • doxorubicin 50 mg/m^2 on Day 1

  • vincristine 1.4 mg/m^2 (maximum 2 mg) on Day 1

  • prednisone 40 mg/m^2 on Day 1 through Day 5

  • Rituximab plus bendamustine (BR) for 6 cycles (28-day cycle)

  • rituximab 375 mg/m^2 on Day 1

  • bendamustine 90 mg/m^2 on Day 1 and Day 2

干预措施: Cyclophosphamide (Drug)

Standard of Care Therapy

Active Comparator

Participants will receive the investigator's choice of one of the following therapies/dosing schedules:

  • Rituximab plus lenalidomide (R^2) for 12 cycles (28-day cycle)

  • Cycle 1: lenalidomide 20 mg/day on Day 1 through Day 21; rituximab 375 mg/m^2 on Day 1, Day 8, Day 15, and Day 22

  • Cycle 2 through Cycle 5: lenalidomide 20 mg/day on Day 1 through Day 21; Rituximab 375 mg/m2 on Day 1

  • Cycle 6 through Cycle 12: lenalidomide 20 mg/day on Day 1 through Day 21

  • Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) for 6 cycles (21-day cycle)

  • rituximab 375 mg/m^2 on Day 1

  • cyclophosphamide 750 mg/m^2 on Day 1

  • doxorubicin 50 mg/m^2 on Day 1

  • vincristine 1.4 mg/m^2 (maximum 2 mg) on Day 1

  • prednisone 40 mg/m^2 on Day 1 through Day 5

  • Rituximab plus bendamustine (BR) for 6 cycles (28-day cycle)

  • rituximab 375 mg/m^2 on Day 1

  • bendamustine 90 mg/m^2 on Day 1 and Day 2

干预措施: Lenalidomide (Drug)

Standard of Care Therapy

Active Comparator

Participants will receive the investigator's choice of one of the following therapies/dosing schedules:

  • Rituximab plus lenalidomide (R^2) for 12 cycles (28-day cycle)

  • Cycle 1: lenalidomide 20 mg/day on Day 1 through Day 21; rituximab 375 mg/m^2 on Day 1, Day 8, Day 15, and Day 22

  • Cycle 2 through Cycle 5: lenalidomide 20 mg/day on Day 1 through Day 21; Rituximab 375 mg/m2 on Day 1

  • Cycle 6 through Cycle 12: lenalidomide 20 mg/day on Day 1 through Day 21

  • Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) for 6 cycles (21-day cycle)

  • rituximab 375 mg/m^2 on Day 1

  • cyclophosphamide 750 mg/m^2 on Day 1

  • doxorubicin 50 mg/m^2 on Day 1

  • vincristine 1.4 mg/m^2 (maximum 2 mg) on Day 1

  • prednisone 40 mg/m^2 on Day 1 through Day 5

  • Rituximab plus bendamustine (BR) for 6 cycles (28-day cycle)

  • rituximab 375 mg/m^2 on Day 1

  • bendamustine 90 mg/m^2 on Day 1 and Day 2

干预措施: Rituximab (Drug)

Standard of Care Therapy

Active Comparator

Participants will receive the investigator's choice of one of the following therapies/dosing schedules:

  • Rituximab plus lenalidomide (R^2) for 12 cycles (28-day cycle)

  • Cycle 1: lenalidomide 20 mg/day on Day 1 through Day 21; rituximab 375 mg/m^2 on Day 1, Day 8, Day 15, and Day 22

  • Cycle 2 through Cycle 5: lenalidomide 20 mg/day on Day 1 through Day 21; Rituximab 375 mg/m2 on Day 1

  • Cycle 6 through Cycle 12: lenalidomide 20 mg/day on Day 1 through Day 21

  • Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) for 6 cycles (21-day cycle)

  • rituximab 375 mg/m^2 on Day 1

  • cyclophosphamide 750 mg/m^2 on Day 1

  • doxorubicin 50 mg/m^2 on Day 1

  • vincristine 1.4 mg/m^2 (maximum 2 mg) on Day 1

  • prednisone 40 mg/m^2 on Day 1 through Day 5

  • Rituximab plus bendamustine (BR) for 6 cycles (28-day cycle)

  • rituximab 375 mg/m^2 on Day 1

  • bendamustine 90 mg/m^2 on Day 1 and Day 2

干预措施: Doxorubicin (Drug)

Standard of Care Therapy

Active Comparator

Participants will receive the investigator's choice of one of the following therapies/dosing schedules:

  • Rituximab plus lenalidomide (R^2) for 12 cycles (28-day cycle)

  • Cycle 1: lenalidomide 20 mg/day on Day 1 through Day 21; rituximab 375 mg/m^2 on Day 1, Day 8, Day 15, and Day 22

  • Cycle 2 through Cycle 5: lenalidomide 20 mg/day on Day 1 through Day 21; Rituximab 375 mg/m2 on Day 1

  • Cycle 6 through Cycle 12: lenalidomide 20 mg/day on Day 1 through Day 21

  • Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) for 6 cycles (21-day cycle)

  • rituximab 375 mg/m^2 on Day 1

  • cyclophosphamide 750 mg/m^2 on Day 1

  • doxorubicin 50 mg/m^2 on Day 1

  • vincristine 1.4 mg/m^2 (maximum 2 mg) on Day 1

  • prednisone 40 mg/m^2 on Day 1 through Day 5

  • Rituximab plus bendamustine (BR) for 6 cycles (28-day cycle)

  • rituximab 375 mg/m^2 on Day 1

  • bendamustine 90 mg/m^2 on Day 1 and Day 2

干预措施: Vincristine (Drug)

Standard of Care Therapy

Active Comparator

Participants will receive the investigator's choice of one of the following therapies/dosing schedules:

  • Rituximab plus lenalidomide (R^2) for 12 cycles (28-day cycle)

  • Cycle 1: lenalidomide 20 mg/day on Day 1 through Day 21; rituximab 375 mg/m^2 on Day 1, Day 8, Day 15, and Day 22

  • Cycle 2 through Cycle 5: lenalidomide 20 mg/day on Day 1 through Day 21; Rituximab 375 mg/m2 on Day 1

  • Cycle 6 through Cycle 12: lenalidomide 20 mg/day on Day 1 through Day 21

  • Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) for 6 cycles (21-day cycle)

  • rituximab 375 mg/m^2 on Day 1

  • cyclophosphamide 750 mg/m^2 on Day 1

  • doxorubicin 50 mg/m^2 on Day 1

  • vincristine 1.4 mg/m^2 (maximum 2 mg) on Day 1

  • prednisone 40 mg/m^2 on Day 1 through Day 5

  • Rituximab plus bendamustine (BR) for 6 cycles (28-day cycle)

  • rituximab 375 mg/m^2 on Day 1

  • bendamustine 90 mg/m^2 on Day 1 and Day 2

干预措施: Prednisone (Drug)

Standard of Care Therapy

Active Comparator

Participants will receive the investigator's choice of one of the following therapies/dosing schedules:

  • Rituximab plus lenalidomide (R^2) for 12 cycles (28-day cycle)

  • Cycle 1: lenalidomide 20 mg/day on Day 1 through Day 21; rituximab 375 mg/m^2 on Day 1, Day 8, Day 15, and Day 22

  • Cycle 2 through Cycle 5: lenalidomide 20 mg/day on Day 1 through Day 21; Rituximab 375 mg/m2 on Day 1

  • Cycle 6 through Cycle 12: lenalidomide 20 mg/day on Day 1 through Day 21

  • Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) for 6 cycles (21-day cycle)

  • rituximab 375 mg/m^2 on Day 1

  • cyclophosphamide 750 mg/m^2 on Day 1

  • doxorubicin 50 mg/m^2 on Day 1

  • vincristine 1.4 mg/m^2 (maximum 2 mg) on Day 1

  • prednisone 40 mg/m^2 on Day 1 through Day 5

  • Rituximab plus bendamustine (BR) for 6 cycles (28-day cycle)

  • rituximab 375 mg/m^2 on Day 1

  • bendamustine 90 mg/m^2 on Day 1 and Day 2

干预措施: Bendamustine (Drug)

结局指标

主要结局

Progression-free Survival (PFS) as Assessed by Blinded Central Assessment per Lugano Classification

时间窗: Up to 5 years

PFS is defined as the time from randomization to disease progression or death due to any cause.

次要结局

  • Event Free Survival (EFS) as Assessed by Blinded Central Assessment per Lugano Classification(Up to 5 years)
  • Complete Response (CR) Rate as Assessed by Blinded Central Assessment per Lugano Classification(Up to 5 years)
  • Overall Survival (OS)(Up to 5 years)
  • Objective Response Rate (ORR) as Assessed by Blinded Central Assessment per Lugano Classification(Up to 5 years)
  • 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)
  • Duration of Response (DOR) as Assessed by Blinded Central Assessment per Lugano Classification(Up to 5 years)
  • Duration of CR as Assessed by Blinded Central Assessment per Lugano Classification(Up to 5 years)
  • Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)(Randomization up to 5 years plus 30 days)
  • 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)(Baseline, up to 5 years)
  • Change From Baseline in the Physical Functioning Domain of the EORTC QLQ-C30(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)(Baseline, up to 5 years)
  • Change From Baseline in the Physical Functioning Domain of the NHL-LG20(Baseline, up to 5 years)
  • Changes From Baseline in the European Quality of Life Five Dimensions Five Levels Scale (EQ-5D-5L)(Baseline, up to 5 years)
  • Time to Next Treatment (TTNT)(Up to 5 years)
  • Changes From Baseline in the Visual Analog Scale (VAS) Scores(Baseline, up to 5 years)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (52)

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