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Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 1 and Cohort 2)
Recruiting
I'm InterestedTrial ID: NCT02601313
Purpose
The goal of this clinical study is to test how well the study drug, brexucabtagene autoleucel
(KTE-X19), works in participants with relapsed/refractory (r/r) mantle cell lymphoma (MCL).
Official Title
A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects With Relapsed/Refractory Mantle Cell Lymphoma
Stanford Investigator(s)
David Miklos
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Eligibility
Key Inclusion Criteria:
Up to 5 prior regimens for MCL. Prior therapy must have included:
- Anthracycline or bendamustine-containing chemotherapy and
- Anti-CD20 monoclonal antibody therapy and
- Ibrutinib or acalabrutinib
At least 1 measurable lesion
Platelet count ≥ 75,000/uL
Creatinine clearance (as estimated by Cockcroft Gault) > or = to 60 mL/min
Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an
echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings
Baseline oxygen saturation >92% on room air.
Key Exclusion Criteria:
- Known history of infection with human immunodeficiency virus (HIV) or hepatitis B
(HBsAG positive) or hepatitis C virus (anti-HCV positive). A history of hepatitis B or
hepatitis C is permitted if the viral load is undetectable per standard serological
and genetic testing
- History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia,
cerebellar disease, cerebral edema, posterior reversible encephalopathy syndrome, or
any autoimmune disease with central nervous system (CNS) involvement
- Presence of fungal, bacterial, viral, or other infection that is uncontrolled or
requiring IV antimicrobials for management.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention(s):
drug: Cyclophosphamide
drug: Fludarabine
biological: brexucabtagene autoleucel
drug: Axicabtagene Ciloleucel
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061