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A Study Evaluating KTE-C19 in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r ALL) (ZUMA-3) (ZUMA-3)

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ClinicalTrials.gov Identifier: NCT02614066
Recruitment Status : Recruiting
First Posted : November 25, 2015
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
Kite, A Gilead Company

Brief Summary:
This is a single arm, open-label, multi-center, phase 1/2 study, to determine the safety and efficacy of KTE-C19, an autologous anti-CD19 chimeric antigen receptor (CAR)-positive T cell therapy, in relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL).

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Biological: KTE-C19 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1-2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-C19 in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r ALL) (ZUMA-3)
Study Start Date : November 2015
Estimated Primary Completion Date : March 2019


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Phase 1: Safety (Incidence of adverse events defined as dose-limiting toxicities (DLT) [ Time Frame: 30 Days ]
  2. Phase 2: Overall complete remission rate [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Duration of Remission [ Time Frame: 12 Months ]
  2. Minimum Residual Disease Negative Remission Rate [ Time Frame: 8 Weeks ]
  3. Allogeneic Stem Cell Transplant Rate [ Time Frame: 12 Months ]
  4. Overall Survival [ Time Frame: 12 Months ]


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

Inclusion Criteria:

  1. Relapsed or refractory B-precursor ALL defined as one of the following:

    • Primary refractory disease
    • First relapse if first remission ≤ 12 months
    • Relapsed or refractory disease after first or later salvage therapy
    • Relapsed or refractory disease after allogeneic transplant provided subject is at least 100 days from stem cell transplant at the time of enrollment
  2. Morphological disease in the bone marrow (≥ 5% blasts)
  3. Subjects with Ph+ disease are eligible if they are intolerant to tyrosine kinase inhibitor (TKI) therapy, or if they have relapsed/refractory disease despite treatment with at least 2 different TKIs
  4. Age 18 or older
  5. Eastern cooperative oncology group (ECOG) performance status of 0 or 1
  6. Adequate renal, hepatic, pulmonary and cardiac function defined as:

    • Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 cc/min
    • Serum ALT/AST ≤ 2.5 x ULN
    • Total bilirubin ≤ 1.5 mg/dl, except in subjects with Gilbert's syndrome.
    • Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion, and no clinically significant arrhythmias
    • Baseline oxygen saturation > 92% on room air
  7. In subjects previously treated with blinatumomab, CD19 tumor expression in bone marrow or peripheral blood.

Exclusion Criteria:

  1. Diagnosis of Burkitt's leukemia/lymphoma according to WHO classification or chronic myelogenous leukemia lymphoid blast crisis
  2. History of malignancy other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least 3 years
  3. Isolated extramedullary disease
  4. CNS abnormalities

    • Presence of CNS-3 disease or CNS-2 disease with neurological changes
    • History or presence of any CNS disorder such as a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement
  5. History of concomitant genetic syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome or any other known bone marrow failure syndrome
  6. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment
  7. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment.
  8. Primary immunodeficiency
  9. Known infection with HIV, hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive).
  10. Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management.
  11. Prior medication:

    • Salvage chemotherapy including TKIs for Ph+ ALL within 1 week prior to enrollment
    • Prior CD19 directed therapy other than blinatumomab
    • Treatment with alemtuzumab within 6 months prior to leukapheresis, or treatment with clofarabine or cladribine within 3 months prior to leukapheresis
    • Donor lymphocyte infusion (DLI) within 28 days prior to enrollment
    • Any drug used for GVHD within 4 weeks prior to enrollment
    • At least 3 half-lives must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy prior to enrollment
    • Corticosteroid therapy for 7 days prior to enrollment
  12. Presence of any indwelling line or drain (e.g., percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, or pleural/peritoneal/pericardial catheter). Ommaya reservoirs and dedicated central venous access catheters such as a Port-a-Cath or Hickman catheter are permitted
  13. Acute GVHD grade II-IV by Glucksberg criteria or severity B-D by IBMTR index; acute or chronic GVHD requiring systemic treatment within 4 weeks prior to enrollment
  14. Live vaccine ≤ 4 weeks prior to enrollment
  15. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. Females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential
  16. Subjects of both genders of child-bearing potential who are not willing to practice birth control from the time of consent through 6 months after the completion of KTE-C19
  17. In the investigators judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation
  18. History of autoimmune disease (e.g. Crohns, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years

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 ClinicalTrials.gov identifier (NCT number): NCT02614066


Contacts
Contact: Medical Information 844-454-KITE medinfo@kitepharma.com

Locations
United States, California
UC San Diego Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Contact: Krisma Montalvo    858-822-6843    kcmontalvo@AD.UCSD.EDU   
University of California Los Angeles (UCLA) Recruiting
Los Angeles, California, United States, 90095
Contact: Bruck Habtemariam       bhabtemariam@mednet.ucla.edu   
Contact: Farzam Hariri, MD    310-206-5756    FHariri@mednet.ucla.edu   
University of California Irvine Medical Center Recruiting
Orange, California, United States, 92868
Contact: Blake Johnson       blakej@uci.edu   
Contact: Jinah Chung       jinahec@uci.edu   
University of California Davis Comprehensive Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Kelly Jones    916-734-1093    kmjjones@ucdavis.edu   
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Erika Cavallone    415-476-4765    Erika.Cavallone@ucsf.edu   
Contact: Rachel Johnson    415-476-4125    rachel.johnson@ucsf.edu   
United States, Florida
H Lee Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Matthew Scott    813-745-6939    Matthew.Scott@moffitt.org   
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States
Contact: Kunhee Lee       kunhee.lee@emoryhealthcare.org   
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Alexis Small    773-702-9440    asmall@medicine.bsd.uchicago.edu   
Contact: Ray Robinson    773-702-2023    rrobinson7@medicine.bsd.uchicago.edu   
Loyola University Recruiting
Chicago, Illinois, United States, 60660
Contact: Elizabeth Jasky    708-327-3095    ejaksy@luc.edu   
Principal Investigator: Patrick Stiff, MD         
United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Sunita Philip    410-328-8199    sphilip1@umm.edu   
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Matthew Jacobs       Matthew_Jacobs@DFCI.HARVARD.EDU   
Contact: Victoria Allen       VALLEN2@PARTNERS.ORG   
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Mariam Shafiq       Shafiq.mariam@mayo.edu   
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Phil Powell    314-747-2740    charles.powell@wustl.edu   
Principal Investigator: Armin Ghobadi, MD         
United States, New York
Mount Sinai Tisch Cancer Institute Recruiting
New York, New York, United States, 10029
Contact: Megan Carmoody    212-241-1598    Megan.Carmody@mssm.edu   
Contact: Sonia Rau       sonia.rai@mssm.edu   
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Yvette Bernal    646-888-1370    bernaly@mskcc.org   
Principal Investigator: JaeHong Park, MD         
University of Rochester Recruiting
New York, New York, United States, 14642
Contact: Shawna Worth       Shawna_worth@URMC.Rochester.edu   
Contact: Robin Boerman       Robin_Boerman@urmc.rochester.edu   
United States, Tennessee
Sarah Cannon Recruiting
Nashville, Tennessee, United States, 37203
Contact: Tiffany Cardona    615-329-7254    tiffany.cordona@scresearch.net   
Contact: Jessica Johnson    615-329-7355    JessicaM.Johnson@scresearch.net   
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37212
Contact: Amber Lee       Amber.d.lee@vanderbilt.edu   
United States, Texas
Baylor Charles A. Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
Contact: Erica Goetz       erica.goetz@bswhealth.org   
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Emily Jones       EDJones2@mdanderson.org   
United States, Washington
Swedish Cancer Institute Recruiting
Seattle, Washington, United States, 98104
Contact: Neil Bailey    206-215-1471    Neil.Bailey@swedish.org   
Seattle Cancer Center Recruiting
Seattle, Washington, United States, 98109
Contact: Lilli Johnson    206-667-3608    Ljjohns3@fredhutch.org   
Principal Investigator: Ryan Cassaday, MD         
Canada, Ontario
University Health Network - Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Nicole Luimes       nicole.luimes@uhn.ca   
Principal Investigator: Andre Schuh, MD         
Sponsors and Collaborators
Kite, A Gilead Company
Investigators
Study Director: Rajul Jain, M.D. Kite, A Gilead Company

Responsible Party: Kite, A Gilead Company
ClinicalTrials.gov Identifier: NCT02614066     History of Changes
Other Study ID Numbers: KTE-C19-103
First Posted: November 25, 2015    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases