Study Evaluating KTE-C19 in Pediatric and Adolescent Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia



Status:Recruiting
Conditions:Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:2 - 21
Updated:4/6/2019
Start Date:February 1, 2016
End Date:January 2036
Contact:Medical Information
Email:medinfo@kitepharma.com
Phone:1-844-454-5483(1-844-454-KITE)

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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 (ZUMA-4)

The primary objectives of this study are to evaluate the safety and efficacy of KTE-C19 in
pediatric and adolescent participants with relapsed/refractory (r/r) B-precursor acute
lymphoblastic leukemia (ALL).


Key Inclusion Criteria:

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

- Primary refractory disease

- Relapsed or refractory disease after 2 or more lines of systemic therapy

- Relapsed or refractory disease after allogeneic transplant provided individual is
at least 100 days from stem cell transplant at the time of enrollment

- Morphological disease in the bone marrow (> 5% blasts)

- Individuals 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

- Ages 2 to 21 at the time of Assent or Consent per institutional review board (IRB)
guidelines

- 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

- Adequate renal, hepatic, pulmonary and cardiac function defined as:

- Creatinine clearance ≥ 60 cc/min

- Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 5 x upper
limit of normal (ULN)

- Total bilirubin ≤ 1.5 x ULN, except in individuals with Gilbert's syndrome

- Left ventricular shortening fraction (LVSF) ≥ 30% or left ventricular ejection
fraction (LVEF) ≥ 50%, no evidence of pericardial effusion as determined by an
echocardiogram, and no clinical significant arrhythmias

- No clinically significant pleural effusion

- Baseline oxygen saturation > 92% on room air

Key Exclusion Criteria

- Diagnosis of Burkitt's leukemia/lymphoma according to the World Health Organization
(WHO) classification or chronic myelogenous leukemia lymphoid blast crisis

- 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

- History of severe hypersensitivity reaction to aminoglycosides or any of the agents
used in this study

- Presence of central nervous system (CNS)-3 disease and CNS-2 disease with neurological
changes

- History of concomitant genetic syndrome such as Fanconi anemia, Kostmann syndrome,
Shwachman-Diamond syndrome or any other known bone marrow failure syndrome

- History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or
other clinically significant cardiac disease within 12 months of enrollment

- History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of
enrollment.

- Primary immunodeficiency

- Known infection with HIV, hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV
positive)

- Presence of fungal, bacterial, viral, or other infection that is uncontrolled or
requiring IV antimicrobials for management.

- Prior medication:

- Prior CD19 directed therapy, including CAR+ T cell, BiTE, and antibody drug
conjugate (ADC), with the exception of individuals 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 graft-versus-host disease (GVHD) within 4 weeks prior to
enrollment

- 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

- Live vaccine ≤ 6 weeks prior to start of conditioning regimen

- 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

- Individuals 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
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San Francisco, California 94143
Phone: 415-476-3982
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Phone: 773-702-0943
University of Chicago One of the world's premier academic and research institutions, the University of...
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Phone: 323-361-2480
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Principal Investigator: Stephan Grupp, MD, PhD
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
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Baltimore, Maryland 21218
(410) 516-8000
Johns Hopkins The Johns Hopkins University opened in 1876, with the inauguration of its first...
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
Principal Investigator: Daniel Lee, MD
Phone: 434-924-0370
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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Cincinnati, Ohio 45229
Phone: 513-803-3255
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Duarte, California 91010
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6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Principal Investigator: Michael Rytting, MD
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Miami, Florida 33442
Principal Investigator: Edward Ziga, MD
Phone: 305-243-0850
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Minneapolis, Minnesota 55404
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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Rochester, Minnesota 55905
Phone: 507-284-2657
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555 University Avenue
Toronto, Ontario M5G 1X8
Principal Investigator: Joerg Krueger, MD
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