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

NCT02906371 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-07-02

No results posted yet for this study

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).

Conditions

  • Lymphoblastic Leukemia, Acute, Childhood

Interventions

DRUG

Tocilizumab

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.

DRUG

Tocilizumab

Patients with ˂ 40% blasts in the bone marrow at pre-infusion (\~ Day -5 to -1) will follow the standard CRS Rx algorithm

BIOLOGICAL

CART 19

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.

Sponsors & Collaborators

Principal Investigators

  • Stephan A Grupp, MD,PhD · Children's Hospital of Philadelphia

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
24 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2020-03-11
Completion
2021-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02906371 on ClinicalTrials.gov