This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

A Multi-Center Study Evaluating KTE-C19 in Pediatric and Adolescent Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ZUMA-4)

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2017 by Kite Pharma, Inc.
Sponsor:
Information provided by (Responsible Party):
Kite Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT02625480
First received: December 5, 2015
Last updated: July 25, 2017
Last verified: July 2017
  Purpose
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) in pediatric or adolescent subjects.

Condition Intervention Phase
Acute Lymphoblastic Leukemia Biological: KTE-C19 Phase 1 Phase 2

Study Type: Interventional
Study Design: 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 Pediatric and Adolescent Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r ALL) (ZUMA-4)

Resource links provided by NLM:


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

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

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

Estimated Enrollment: 75
Study Start Date: December 2015
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:   2 Years to 21 Years   (Child, 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
    • 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. Ages 2 to 21 at the time of Assent or Consent per IRB guidelines
  5. Lansky (age < 16 years at the time of assent/consent) or Karnofsky (age ≥ 16 years at the time of assent/consent) performance status ≥ 80 at screening
  6. Adequate renal, hepatic, pulmonary and cardiac function defined as:

    • Creatinine clearance ≥ 60 cc/min
    • Serum ALT/AST ≤ 2.5 x ULN
    • Total bilirubin ≤ 1.5 x ULN
    • Cardiac ejection fraction ≥ 50% and no clinically significant ECG findings
    • Baseline oxygen saturation > 92% on room air

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

    • Prior CD19 directed therapy, including CAR+ T cell, BiTE, and antibody drug conjugate (ADC), with the exception of subjects who received KTE-C19 in this study and are eligible for re-treatment
    • 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
  11. 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
  12. Live vaccine ≤ 6 weeks prior to start of conditioning regimen
  13. 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 are not considered to be of childbearing potential
  14. 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
  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: NCT02625480

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

Locations
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Joseph Rosenthal, MD       jrosenthal@coh.org   
Contact: Sarmad Bahrani       sbahrani@coh.org   
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Alan Wayne, MD       awayne@chla.usc.edu   
Contact: Karen Reed       kreed@chla.usc.edu   
Children's Hospital of Orange County Recruiting
Orange, California, United States, 92868
Contact: Leonard Sender, MD       lsender@uci.edu   
Contact: Laura Gates, RN       lgates@choc.org   
UCSF Benioff Childrens Hospital Recruiting
San Francisco, California, United States, 94158
Contact: Stephanie Schwartz       Stephanie.Schwartz@ucsf.edu   
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Lia Gore, MD       lia.gore@ucdenver.edu   
United States, Maryland
Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21287
Contact: Pat Rice       willipa@jhmi.edu   
Contact: Genevieve Courpas       gcourpa1@jhmi.edu   
United States, Minnesota
Children's Hospitals and Clinics of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Ana Brown       Anastasia.Brown@ChildrensMN.org   
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Debra Schott       schott.debra@mayo.edu   
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Contact: Gina Perez       gina.perez@vanderbilt.edu   
Contact: Amanda Stults       amanda.a.stults@vanderbilt.edu   
United States, Texas
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Helton Cruz       hdcruz@texaschildrens.org   
United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Jessica Pritchard       jep@virginia.edu   
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Adam Fielbelkorn       afiebelk@mcw.edu   
Contact: Rebecca Rehborg       rrehborg@mcw.edu   
Sponsors and Collaborators
Kite Pharma, Inc.
Investigators
Study Director: Rajul Jain, M.D. Kite Pharma, Inc.
  More Information

Responsible Party: Kite Pharma, Inc.
ClinicalTrials.gov Identifier: NCT02625480     History of Changes
Other Study ID Numbers: KTE-C19-104
Study First Received: December 5, 2015
Last Updated: July 25, 2017

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

ClinicalTrials.gov processed this record on September 21, 2017