Study of Efficacy and Safety of CTL019 in Pediatric ALL Patients

Completed · Phase 2

Conditions studied: B-cell Acute Lymphoblastic Leukemia

In brief

This is a single arm, open-label, multi-center, phase II study to determine the efficacy and safety of CTL019 in pediatric patients with r/r B-cell ALL.

Key facts

Study ID

NCT02435849

Run by

Novartis Pharmaceuticals

People needed

80

Starts

2015-04-08

Expected to finish

2022-11-17

Last updated by the study team

2024-02-13

Who can join

Age: any, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Relapsed or refractory pediatric B-cell ALL
• Adequate organ function
• For relapsed patients, documentation of CD19 tumor expression within 3 months of study entry.
• Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening.
• Life expectancy > 12 weeks.
• Karnofsky (age ≥16 years) or Lansky (age < 16 years) performance status ≥ 50 at screening
• Signed written informed consent and assent forms
• Must meet the institutional criteria to undergo leukapheresis or have an acceptable, store leukapheresis product
• Must have an apheresis product of non-mobilized cells received and accepted by the manufacturing site.
• Cohort 1 only:
• First relapse AND hypodiploid cytogenetics OR
• First relapse AND t(17;19) with defined TCF3-HLF fusion OR
• First relapse with any cytogenetics provided the relapse occurred ≤ 36 months of initial diagnosis AND MRD at end of reinduction therapy is ≥0.01% by flow cytometry (local assessment)

You may not qualify if…

• Isolated extra-medullary disease relapse
• Patients with concomitant genetic syndrome: such as patients with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Patients with Down Syndrome will not be excluded.
• Patients with Burkitt's lymphoma/leukemia (i.e. patients with mature B-cell ALL, leukemia with B-cell [sIg positive and kappa or lambda restricted positivity] ALL, with FAB L3 morphology and /or a MYC translocation)
• Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease
• Treatment with any prior gene therapy product
• Has had treatment with any prior anti-CD19/anti-CD3 therapy, or any other anti-CD19 therapy
• Active or latent hepatitis B or active hepatitis C (test within 8 weeks of screening), or any uncontrolled infection at screening
• Human Immunodeficiency Virus (HIV) positive test within 8 weeks of screening
• Presence of grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD).
• Active CNS involvement by malignancy, defined by CNS-3 per NCCN guidelines.
• Patient has an investigational medicinal product within the last 30 days prior to screening.
• Pregnant or nursing (lactating) women.
• Women of child-bearing potential, defined as physiologically capable of becoming pregnant, unless they agree to use highly effective methods of contraception for at least 12 months after the CTL019 infusion and after CAR T-cells are no longer present by qPCR on two consecutive tests
• Sexually active males must use a condom during intercourse at least 12 months after the CTL019 infusion after CAR T-cells are no longer present by qPCR on two consecutive tests

Where it is running

• Childrens Hospital Los Angeles SC CTL019 — Los Angeles, California, United States
• Stanford Universtiy Medical Center SC - CTL019B2205J - B2206 — Stanford, California, United States
• Children's Healthcare of Atlanta SC CTL019 — Atlanta, Georgia, United States
• University of Michigan . — Ann Arbor, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Children s Mercy Hospital SC - CTL019B2205J — Kansas City, Missouri, United States
• Duke Unversity Medical Center . — Durham, North Carolina, United States
• Oregon Health and Science University Doernbecher Children's Hosp. — Portland, Oregon, United States
• The Childrens Hospital of Philadelphia CHOP — Philadelphia, Pennsylvania, United States
• University of Texas Southwestern Medical Center . — Dallas, Texas, United States
• University of Utah Clinical Trials Office SC - CTL019B2205J — Salt Lake City, Utah, United States
• Novartis Investigative Site — Parkville, Victoria, Australia
• Novartis Investigative Site — Vienna, Austria
• Novartis Investigative Site — Ghent, Belgium
• Novartis Investigative Site — Toronto, Ontario, Canada
• Novartis Investigative Site — Montreal, Quebec, Canada
• Novartis Investigative Site — Paris, Cedex 10, France
• Novartis Investigative Site — Paris, France
• Novartis Investigative Site — Frankfurt, Germany
• Novartis Investigative Site — Monza, MB, Italy
• Novartis Investigative Site — Kyoto, Japan
• Novartis Investigative Site — Oslo, Norway
• Novartis Investigative Site — Esplugues de Llobregat, Barcelona, Spain

Full record on ClinicalTrials.gov

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