CompletedPhase 2

Study of Efficacy and Safety of CTL019 in Pediatric ALL Patients

United States80 participantsStarted 2015-04-08

Plain-language summary

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.

Who can participate

Age range25 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Percentage of Participants With Overall Remission Rate (ORR) as Determined by Independent Review Committee (IRC) Assessment.

Timeframe: during the 3 months after tisagenlecleucel administration

Trial details

NCT IDNCT02435849

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-01-21

Results submitted2021-09-23

View on ClinicalTrials.gov More B-cell Acute Lymphoblastic Leukemia trials