CompletedPhase 1

Study of the Tocilizumab Optimization Timing for CART19 Associated Cytokine Release Syndrome

United States80 participantsStarted 2016-08

Plain-language summary

This is a two cohort, open-label, pilot study to describe the efficacy of administration timing of tocilizumab on CART19 (CTL019) associated cytokine release syndrome safety events in pediatric patients with CD19 expressing relapsed and refractory B-cell acute lymphoblastic leukemia with high versus low pre-infusion tumor burden following redirected autologous T cells transduced with the anti-CD19 lentiviral vector (CART19/CTL019).

Who can participate

Age range1 Year – 24 Years

SexALL

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Inclusion criteria

✓. Signed informed consent form must be obtained prior to any study procedure. Labs, marrows or other procedures obtained during routine clinical care may be used for eligibility if obtained within the protocol required windows.
✓. Relapsed or refractory B-cell ALL:
✓. 2nd or greater marrow relapse OR
✓. CNS relapse OR
✓. Any relapse after allogeneic hematopoietic stem cell (SCT) transplant and ≥ 4 months from SCT at enrollment OR
✓. Any relapse after CAR-modified T cell therapy OR
✓. Refractory disease defined as having not achieved an MRD-negative CR after ≥ 2 chemotherapy regimens/cycles (1 cycle for relapsed patients) OR
✓. Patients with Ph+ ALL are eligible if they are intolerant to or have failed tyrosine kinase inhibitor therapy OR

Exclusion criteria

✕. Active hepatitis B or active hepatitis C.
✕. HIV Infection.
✕. Active acute or chronic graft-versus-host disease (GVHD) requiring systemic therapy.

What they're measuring

the frequency of grade 4 CRS

Timeframe: from day 1 to 1 year

Trial details

NCT IDNCT02906371

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-03-11

View on ClinicalTrials.gov More Lymphoblastic Leukemia, Acute, Childhood trials