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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02601313
Recruitment Status : Recruiting
First Posted : November 10, 2015
Last Update Posted : October 4, 2018
Information provided by (Responsible Party):
Kite, A Gilead Company

Brief Summary:
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 or disease Intervention/treatment Phase
Relapsed/Refractory Mantle Cell Lymphoma Biological: KTE-C19 Drug: Cyclophosphamide Drug: Fludarabine Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-C19 in Subjects With Relapsed/Refractory Mantle Cell Lymphoma (ZUMA-2)
Actual Study Start Date : November 2015
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : March 2034

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: KTE-C19
Experimental: Single Arm. A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by a single infusion CAR transduced autologous T cells administered intravenously.
Biological: KTE-C19
Drug: Cyclophosphamide
Administered intravenously

Drug: Fludarabine
Administered intravenously

Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: Up to 24 months ]
    Objective response rate (ORR) is defined as the incidence of a CR or a PR per the Lugano Classification (Cheson et al, 2014), as determined by the Independent Radiology Review Committee (IRRC).

Secondary Outcome Measures :
  1. Duration of Response [ Time Frame: Up to 24 months ]
    Duration of response (DOR) is defined as the time from their first objective response to disease progression or death.

  2. Best Objective Response [ Time Frame: Up to 24 months ]
    Best objective response is defined as the incidence of CR, PR, SD, progressive disease, or unevaluable as best response to treatment

  3. Progression Free Survival [ Time Frame: Up to 24 months ]
    Progression free survival (PFS) is defined as the time from the anti‑CD19 CAR T cells infusion date to the date of disease progression or death from any cause

  4. Objective Response Rate [ Time Frame: Up to 24 months ]
    Objective response rate (ORR) is defined as the incidence of either a CR or PR determined by investigator

  5. Overall Surival [ Time Frame: Up to 15 years ]
    Percentage of participants experiencing treatment-emergent adverse events; Percentage of participants who had clinically significant changes in laboratory values.

  6. Incidence of adverse events (AEs) and clinically significant changes in laboratory values [ Time Frame: Up to 15 years ]
    Percentage of Participants Experiencing Treatment-Emergent Adverse Events; Percentage of participants who had clinically significant changes in laboratory values.

  7. Incidence of anti-KTE-C19 antibodies [ Time Frame: Up to 15 years ]
  8. Levels of anti-CD19 CAR T cells in blood [ Time Frame: Up to 15 years ]
  9. Levels of cytokines in serum [ Time Frame: Up to 15 years ]
  10. Changes over time in the EQ-5D scale score and visual analogue scale score [ Time Frame: Up to 6 months ]
    The EQ-5D consists of a 5-dimension descriptive system, including questions on mobility, self-care, usual activities, pain/comfort, and anxiety/depression, and a visual analogue scale (VAS) that allows the respondent to record health on a vertical scale (eg, best health to worst health), thus allowing a quantitative measure of health outcome.

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02601313

Contact: Medical Information 844-454-KITE

  Hide Study Locations
United States, Arizona
Banner MD Anderson Recruiting
Gilbert, Arizona, United States, 85234
Contact: Andrea Winkle   
Principal Investigator: Javier Munoz, MD, FACP         
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Hormoz Mirshkarlo   
UC San Diego Moores Cancer Center Withdrawn
La Jolla, California, United States, 92093
University California Los Angeles (UCLA) Recruiting
Los Angeles, California, United States, 90095
Contact: Bessie Bautista   
Principal Investigator: John Timmerman, MD         
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Juliana Craig   
Principal Investigator: David Miklos, MD, PhD         
United States, Colorado
Sarah Cannon Recruiting
Denver, Colorado, United States, 80218
Contact: Juli Murphy   
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Nathalie Luis   
Principal Investigator: Amer Beitinjaneh         
H Lee Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Matthew Scott   
United States, Georgia
Winship Cancer Institute of Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Neera Jagirdar   
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Ray Robinson   
Loyola University Chicago Recruiting
Maywood, Illinois, United States, 60153
Contact: Karen Fahey   
Principal Investigator: Patrick Stiff, MD         
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   
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Kelly Azzollini   
United States, New York
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Frances Batarse   
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Bonnie Toaso    919-681-4769   
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Donna Abounader   
James Cancer Hospital and Solove Research Institute Recruiting
Columbus, Ohio, United States, 43210
Contact: Nicole Szuminski   
Principal Investigator: Samantha M. Jaglowski, MD, MPH         
United States, Oregon
Robert W. Franz Cancer Research Center Recruiting
Portland, Oregon, United States, 97213
Contact: Laurie Delanty   
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Saif Majeed   
Principal Investigator: Henry Fung, MD         
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Christy Riggins   
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Stephen Cornelius   
Principal Investigator: Olalekan Oluwole, MD         
United States, Texas
Baylor Charles A. Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
Contact: Sandy Li   
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Maria Badillo   
Contact: Onyeka Oriabure   
Principal Investigator: Michael (Luhua) Wang, MD         
Methodist Hospital Recruiting
San Antonio, Texas, United States, 78229
Contact: JoDell McCracken   
United States, Washington
Swedish Cancer Institute Recruiting
Seattle, Washington, United States, 98104
Contact: Melinh Jones-Nozynski    206-215-2338   
Centre Hospitalier Universitaire (CHU) Recruiting
Bordeaux, France
Contact: Souheyla Boutemane   
Principal Investigator: Noel Miliped, Prof. MD         
Hopital Haut-Leveque Recruiting
Nantes, France, 44035
Hospital Saint Louis Recruiting
Paris, France, 75010
Contact: Awatif Bechrouri   
Principal Investigator: Catherine Thieblemont, MD         
Academisch Medisch Centrum Recruiting
Amsterdam, Netherlands
Contact: Spiering Marjolein    +31 (0)20 5665785   
Principal Investigator: Maria Jose Kersten, MD         
University Medical Center Groningen Recruiting
Groningen, Netherlands
Contact: Charryda Scheper   
Principal Investigator: Tom van Meerten, MD         
Erasmus Medical Center Recruiting
Rotterdam, Netherlands
Contact: Nanda Maas   
Principal Investigator: Pieternella Lugtenburg, MD         
Sponsors and Collaborators
Kite, A Gilead Company
Study Director: Kite Study Director Kite, A Gilead Company

Responsible Party: Kite, A Gilead Company Identifier: NCT02601313     History of Changes
Other Study ID Numbers: KTE-C19-102
2015-005008-27 ( EudraCT Number )
First Posted: November 10, 2015    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Fludarabine phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic