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

Conditions

• Lymphoblastic Leukemia, Acute, Childhood

Eligibility Criteria

Sex

ALL

Age

1 Year - 24 Years

Healthy Volunteers

Not accepted

Interventions

• Tocilizumab — DRUG
  Patients with ≥ 40% blasts in the bone marrow at pre-infusion will be enrolled in the early tocilizumab cohort and will follow early CRS treatment algorithm.
• Tocilizumab — DRUG
  Patients with ˂ 40% blasts in the bone marrow at pre-infusion (\~ Day -5 to -1) will follow the standard CRS Rx algorithm
• CART 19 — BIOLOGICAL
  CART-19 cells transduced with a lentiviral vector to express either anti-CD19ζ scFv TCRζ:41BB, administered by i.v. injection using an intra-patient dose escalation approach: 10% on day 0, 30% on day 1 with a total dose goal of \~1.5 x107 - 5 x109 (\~3x105 - 1x108/kg) T cells.

Study Details

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).

Key Dates

Start date

Aug 31, 2016

Status verified

Jun 2021

Primary completion

Mar 11, 2020

Completion

Jun 30, 2021

Study Design

Enrollment

80 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

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

Primary Outcome Measure

the frequency of grade 4 CRS [ Time Frame: from day 1 to 1 year ]

Locations (1)

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