A Phase 2 Multicenter Study Evaluating Subjects With Relapsed / Refractory Mantle Cell Lymphoma

Status: Active

Description

Study KTE-C19-102 is a phase 2, multicenter, open-label study evaluating the efficacy of KTE-X19 in subjects with Relapsed / Refractory MCL

Eligibility Criteria

Inclusion Criteria

  • Key Inclusion Criteria: Up to 5 prior regimens for mantle cell lymphoma (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) > 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 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 & Contacts

California

Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Contact: Sarmad Bahrani
Email: sbahrani@coh.org
Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Contact: Lia Etheridge
Phone: 310-825-7174
Email: LEtheridge@mednet.ucla.edu

Florida

Tampa
Moffitt Cancer Center
Status: Active
Contact: Frederick Lundry Locke
Phone: 800-456-7121
Email: canceranswers@moffitt.org

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: Active
Name Not Available

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: Active
Name Not Available

Massachusetts

Boston
Brigham and Women's Hospital
Status: Active
Name Not Available
Dana-Farber Cancer Institute
Status: Active
Contact: Michael Rocchio
Email: MichaelJ_Rocchio@DFCI.HARVARD.EDU

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: Active
Name Not Available

North Carolina

Durham
Duke University Medical Center
Status: Active
Name Not Available

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: Temporarily closed to accrual
Name Not Available
Columbus
Ohio State University Comprehensive Cancer Center
Status: Active
Name Not Available

Pennsylvania

Philadelphia
Fox Chase Cancer Center
Status: Active
Name Not Available

Texas

Houston
M D Anderson Cancer Center
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Kite, A Gilead Company

Trial IDs

Primary ID KTE-C19-102
Secondary IDs NCI-2015-02028, 2015-005008-27
Clinicaltrials.gov ID NCT02601313