Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

The primary objective of the study is to evaluate the efficacy of brexucabtagene autoleucel (KTE-X19) in participants with relapsed/refractory 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

Keywords

Relapsed/Refractory Mantle Cell Lymphoma Lymphoma Lymphoma, Mantle-Cell Cyclophosphamide Fludarabine brexucabtagene autoleucel Axicabtagene Ciloleucel Axicabtagene ciloleucel/brexucabtagene autoleucel (KTE-X19)

Eligibility

You can join if…

Open to people ages 18 years and up

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.

You CAN'T join if...

  • 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.

Locations

  • University California Los Angeles (UCLA)
    Santa Monica California 90404 United States
  • City of Hope
    Duarte California 91010 United States
  • Stanford University
    Stanford California 94305 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Kite, A Gilead Company
ID
NCT02601313
Phase
Phase 2
Study Type
Interventional
Last Updated