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NCT02906371 · ClinicalTrials.gov registry record · Phase 1
Study of the Tocilizumab Optimization Timing for CART19 Associated Cytokine Release Syndrome
A Phase 1 study of Lymphoblastic Leukemia, Acute, Childhood, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT02906371: Completed Phase 1 study of Lymphoblastic Leukemia, Acute, Childhood, sponsored by University of Pennsylvania.
NCT02906371 is a Phase 1 study of Lymphoblastic Leukemia, Acute, Childhood that has completed, run by University of Pennsylvania. The registered enrollment target is 80 participants, above the 26-participant average among 4 other Lymphoblastic Leukemia, Acute, Childhood trials with a reported enrollment target (208% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02906371, a Phase 1 study of Lymphoblastic Leukemia, Acute, Childhood, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
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).
Primary Outcome
Frequency of CRS grade 4
Conditions Studied
Interventions
- DRUG Tocilizumab
- BIOLOGICAL CART 19
Study Locations (1)
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2016-08 |
| Est. Completion | 2021-06-30 |
| Phase | Phase 1 |
What the finished NCT02906371 record still lists
NCT02906371 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, above the 26-participant average among 4 other Lymphoblastic Leukemia, Acute, Childhood trials with a reported enrollment target (208% higher).
The record links to 1 condition, with Lymphoblastic Leukemia, Acute, Childhood appearing as the primary indexed condition, and to 2 interventions - of which Tocilizumab is the first listed.
NCT02906371 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02906371 about?
NCT02906371 is a clinical study titled "Study of the Tocilizumab Optimization Timing for CART19 Associated Cytokine Release Syndrome". 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...
What is the current status of trial NCT02906371?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2016-08. Estimated completion is 2021-06-30.
What conditions does trial NCT02906371 study?
This clinical trial studies the following conditions: Lymphoblastic Leukemia, Acute, Childhood.
What interventions are being tested in trial NCT02906371?
The interventions under investigation include: Tocilizumab (DRUG), CART 19 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02906371?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02906371 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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