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Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma
The goal of this clinical study is to compare the study drug, axicabtagene ciloleucel, versus standard of care (SOC) in first-line therapy in participants with high-risk large B-cell lymphoma.
Study details:
Five years after randomization, 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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-02-10
Primary completion: 2031-03-01
Study completion finish: 2031-03-01
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT05605899
Intervention or treatment
BIOLOGICAL: Axicabtagene Ciloleucel
DRUG: Cyclophosphamide
DRUG: Fludarabine
DRUG: Etoposide
DRUG: Rituximab
DRUG: Doxorubicin
DRUG: Vincristine
DRUG: Prednisone
Conditions
- • High-risk Large B-cell Lymphoma (LBCL)
Find a site
Closest Location:
Royal Prince Alfred Hospital
Research sites nearby
Select from list below to view details:
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Peter MacCallum Cancer Center
Melbourne, Victoria, Australia
Royal Brisbane and Women's Hospital
South Brisbane, Queensland, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Axicabtagene Ciloleucel
| BIOLOGICAL: Axicabtagene Ciloleucel
|
ACTIVE_COMPARATOR: Standard of Care Therapy
| DRUG: Cyclophosphamide
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Event-free Survival (EFS) by Blinded Central Assessment | EFS, is defined as the time from randomization to the earliest occurrence of death due to any cause, disease progression/relapse, initiation of any non-protocol specified subsequent new lymphoma therapy for the treatment of residual disease or Biopsy-proven residual disease at the Month 6 disease assessment or later, regardless of whether subsequent new lymphoma therapy is initiated or not. | Up to 5 years |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Progression-free Survival (PFS) by Blinded Central Assessment | PFS is defined as the time from randomization to disease progression or death due to any cause. | Up to 5 years |
Overall Survival | OS is defined as the time from randomization to death due to any cause. | Up to 5 years |
PFS by Investigator Assessment | PFS is defined as the time from randomization to disease progression or death due to any cause. | Up to 5 years |
Complete Response (CR) Rate by Blinded Central Assessment | CR rate is defined as the proportion of participants who have achieved CR per Lugano classification after treatment completion and prior to subsequent new off protocol anti-lymphoma therapy. | Up to 5 years |
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Deaths | Not Specified | First dose date up to 5 years plus 30 days |
Percentage of Participants Experiencing Clinically Significant Changes in Safety Laboratory Values | Not Specified | First dose date up to 5 years plus 30 days |
Change From Baseline in the European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-30 (EORTC QLQ-C30) Score | 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, six (6) symptom single-item 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, Month 18 |
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Non-Hodgkin Lymphoma High Grade Module (EORTC QLQ-NHL-HG29) Score | The EORTC QLQ-NHL-HG29 is a 29-item patient-reported assessment measuring patients' high-grade NHL-specific symptoms and functioning. The 29 items assess symptom burden due to disease and/or treatment, fatigue/physical condition, neuropathy, emotional impacts, and worries/fears health and functioning. Each scale is measured from 0 to 100 after a linear transformation. Higher scores for functional scales indicate a higher level of functioning and a better HRQoL, whereas higher scores in symptom scales represent a higher level of symptoms. | Baseline, Month 18 |
Change From Baseline in the European Quality of Life Five Dimensions Five Levels Questionnaire (EQ-5D-5L) Score | 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, Month 18 |
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