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A Phase 2 Multicenter Study Evaluating Subjects With Relapsed/Refractory Mantle Cell Lymphoma (ZUMA-2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Kite Pharma, Inc.
Sponsor:
Information provided by (Responsible Party):
Kite Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT02601313
First received: November 6, 2015
Last updated: March 22, 2017
Last verified: September 2016
  Purpose
Study KTE-C19-102 is a phase 2, multicenter, open-label study evaluating the efficacy of KTE-C19 in subjects with Relapsed/Refractory MCL

Condition Intervention Phase
Relapsed/Refractory Mantle Cell Lymphoma
Biological: KTE-C19
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-C19 in Subjects With Relapsed/Refractory Mantle Cell Lymphoma (r/r MCL) (ZUMA-2)

Resource links provided by NLM:


Further study details as provided by Kite Pharma, Inc.:

Primary Outcome Measures:
  • Phase 2: Overall Response Rate [ Time Frame: 12 months ]
    • Objective response rate (complete response [CR] + partial response [PR]) per the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma


Secondary Outcome Measures:
  • Duration of Response [ Time Frame: 12 Months ]
  • Best Objective Response [ Time Frame: 12 Months ]
  • Progression Free Survival [ Time Frame: 12 Months ]

Estimated Enrollment: 70
Study Start Date: November 2015
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KTE-C19
Experimental: Single Arm A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by a single infusion of CAR transduced autologous T cells administered intravenously at a target dose of 2 x 10^6 anti-CD19 CAR+ T cells/kg
Biological: KTE-C19

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Pathologically confirmed MCL
  • 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
  • Relapsed or refractory disease, defined by the following:

    • Disease progression after last regimen, or
    • Refractory disease is defined failure to achieve a PR or CR to the last regimen
  • At least 1 measurable lesion according to the revised IWG Response Criteria for Malignant Lymphoma
  • Age 18 years or older
  • Eastern cooperative oncology group (ECOG) performance status of 0 or 1
  • ANC ≥ 1000/µL
  • Platelet count ≥ 50,000/µL
  • Adequate renal, hepatic, and cardiac function defined as:

    • Serum creatinine ≤ 1.5 mg/dL
    • Serum ALT/AST ≤ 2.5 ULN
    • Total bilirubin ≤ 1.5 mg/dL, except in subjects with Gilbert's syndrome.
    • Cardiac ejection fraction ≥ 50% (by ECHO) and no evidence of pericardial effusion as determined by an ECHO.

Key Exclusion Criteria:

  • History of malignancy other than nonmelanomatous skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least 3 years
  • History of allogeneic stem cell transplantation
  • Prior CD19 targeted therapy
  • Prior CAR therapy or other genetically modified T cell therapy
  • Known history of infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive)
  • Subjects with detectable cerebrospinal fluid malignant cells or brain metastases or with a history of cerebrospinal fluid malignant cells or brain metastases
  • History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02601313

Contacts
Contact: Allison Bowen, MPM, PMP, BS, BA Allison.Bowen@Chiltern.com

Locations
United States, Arizona
Banner MD Anderson Recruiting
Gilbert, Arizona, United States, 85234
Contact: Andrea Horstman       andrea.horstman@bannerhealth.com   
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Sarmad Bahrani       sbahrani@coh.org   
UC San Diego Moores Cancer Center Withdrawn
La Jolla, California, United States, 92093
Stanford Recruiting
Stanford, California, United States, 94305
Contact: Ryan Le       ryanle@stanford.edu   
United States, Colorado
Sarah Cannon Recruiting
Denver, Colorado, United States, 80218
Contact: Juli Murphy       juli.murphy@healthonecares.com   
United States, Florida
H Lee Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Beth Bresee       Bethany.Bresee@moffitt.org   
United States, Georgia
Winship Cancer Institute of Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Neera Jagirdar       neera.jagirdar@emory.edu   
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Linda Schroeder       lschroed@medicine.bsd.uchicago.edu   
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Michael Rocchio       MichaelJ_Rocchio@DFCI.HARVARD.EDU   
United States, Michigan
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Marie Ventimiglia       ventimim@karmanos.org   
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: William Marrero       william.marrero@hackensackmeridian.org   
United States, New York
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Elizabeth Baloga       elizabeth_baloga@urmc.rochester.edu   
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Donna Abounader       abounad2@ccf.org   
United States, Oregon
Robert W. Franz Cancer Research Center Recruiting
Portland, Oregon, United States, 97213
Contact: Laurie Delanty       laurie.delanty@providence.org   
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Tiffany Cardona       tiffany.cardona@scresearch.net   
United States, Texas
Baylor Charles A. Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
Contact: Sandy Li       Sandy.Li@BSWHealth.org   
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Maria Badillo       mrbadill@mdanderson.org   
Contact: Onyeka Oriabure       ONOkonkwo@mdanderson.org   
Methodist Hospital Recruiting
San Antonio, Texas, United States, 78229
Contact: JoDell McCracken       jodell.mccracken@mhshealth.com   
Sponsors and Collaborators
Kite Pharma, Inc.
Investigators
Study Director: William Go, M.D., Ph.D. Kite Pharma, Inc.
  More Information

Responsible Party: Kite Pharma, Inc.
ClinicalTrials.gov Identifier: NCT02601313     History of Changes
Other Study ID Numbers: KTE-C19-102
Study First Received: November 6, 2015
Last Updated: March 22, 2017

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on March 28, 2017