Study Evaluating the Safety and Efficacy of KTE-C19 in Adult Participants With Refractory Aggress… (NCT02348216) | Clinical Trial Compass
CompletedPhase 1/2
Study Evaluating the Safety and Efficacy of KTE-C19 in Adult Participants With Refractory Aggressive Non-Hodgkin Lymphoma
United States307 participantsStarted 2015-04-21
Plain-language summary
This study will be separated into 3 distinct phases designated as the Phase 1 study, Phase 2 pivotal study (Cohort 1 and Cohort 2), and Phase 2 safety management study (Cohort 3 and Cohort 4, Cohort 5 and Cohort 6).
The primary objectives of this study are:
* Phase 1 Study: Evaluate the safety of axicabtagene ciloleucel regimens
* Phase 2 Pivotal Study; Evaluate the efficacy of axicabtagene ciloleucel
* Phase 2 Safety Management Study: Assess the impact of prophylactic regimens or earlier interventions on the rate and severity of cytokine release syndrome (CRS) and neurologic toxicities
Subjects who received an infusion of KTE-C19 will complete the remainder of the 15 year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histologically confirmed:
✓. Chemotherapy-refractory disease, defined as one of more of the following:
✓. Individuals must have received adequate prior therapy including at a minimum:
✓. At least one measurable lesion per revised international working group (IWG Response Criteria
✓. Eastern cooperative oncology group (ECOG) performance status of 0 or 1
✕. History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) or follicular lymphoma unless disease free for at least 3 years
✕. History of allogeneic stem cell transplantation
What they're measuring
1
Phase 1 Study: Number of Participants Experiencing Adverse Events (AEs) Defined as Dose Limiting Toxicities (DLTs)
Timeframe: First infusion date of axicabtagene ciloleucel up to 30 days
2
Phase 2 Pivotal Study (Cohorts 1 and 2): Overall Response Rate (ORR) as Assessed by Investigator Per Revised International Working Group (IWG) Response Criteria for Malignant Lymphoma
Timeframe: First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 7.7 years)
3
Phase 2 Safety Management Study (Cohort 3): Percentage of Participants With Treatment-Emergent Cytokine Release Syndrome (CRS) and Neurologic Toxicities by Severity Grades
Timeframe: First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 6.8 years)
4
Phase 2 Safety Management Study (Cohort 4): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades
Timeframe: First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 5.4 years)
5
Phase 2 Safety Management Study (Cohort 5): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades
Timeframe: First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 4.4 years)
6
Phase 2 Safety Management Study (Cohort 6): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades
✕. Prior chimeric antigen receptor (CAR) therapy or other genetically modified T cell therapy
✕. Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous (IV) antimicrobials for management. Simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted if responding to active treatment
✕. History of human immunodeficiency virus (HIV) infection or acute or chronic active hepatitis B or C infection. Individuals with history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing per current Infectious Diseases Society of America (IDSA) guidelines
✕. Individuals with detectable cerebrospinal fluid malignant cells, or brain metastases, or with a history of central nervous system (CNS) lymphoma or primary CNS lymphoma, cerebrospinal fluid malignant cells or brain metastases
✕. History or presence of CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement
Timeframe: First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 4.1 years)