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NCT01683279 · ClinicalTrials.gov registry record · Phase 1

A Pediatric Trial of Genetically Modified Autologous T Cells Directed Against CD19 for Relapsed CD19+ Acute Lymphoblastic Leukemia

A Phase 1 study of B-cell Leukemia, sponsored by Seattle Children's Hospital.

Active
Registry status
Phase 1
Development phase
6
Enrollment target
1
Study location

NCT01683279: Active Phase 1 study of B-cell Leukemia, sponsored by Seattle Children's Hospital.

NCT01683279 is a Phase 1 study of B-cell Leukemia that is active but no longer recruiting, run by Seattle Children's Hospital. The registered enrollment target is 6 participants, below the 164-participant average among 3 other B-cell Leukemia trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01683279, a Phase 1 study of B-cell Leukemia, is active but no longer recruiting, sponsored by Seattle Children's Hospital.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
6 participants
Enrollment target
1
Study location

Study Summary

Patients with relapsed leukemia often develop resistance to chemotherapy. For this reason, we are attempting to use a patient's own T cells, which can be genetically modified to expresses a chimeric antigen receptor(CAR). The CAR enables the T cell to recognize and kill the leukemic cells though the recognition of CD19, a protein expressed on the surface of the majority of pediatric ALL. This is a phase I study designed to determine the maximum tolerated dose of the CAR+ T cells and define the toxicity of the treatment. As a secondary aim, we will be looking at the efficacy of the T cells on eradicating the patient's leukemic cells.

Primary Outcome

The safety of the T cell infusion will be described and the maximum tolerated dose determined.

Conditions Studied

Interventions

  • BIOLOGICAL Autologous CD19 CAR+ EGFTt + T cells

Study Locations (1)

Washington

  • Seattle Children's Hospital - Seattle

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2012-03-25
Est. Completion 2030-01-07
Phase Phase 1
Seattle Children's Hospital

168 total trials

What the registry record for NCT01683279 still lists

NCT01683279 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 164-participant average among 3 other B-cell Leukemia trials with a reported enrollment target (96% lower).

The record links to 1 condition, with B-cell Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Autologous CD19 CAR+ EGFTt + T cells is the first listed.

NCT01683279 reports a single indexed study location in Washington.

Frequently Asked Questions

What is clinical trial NCT01683279 about?

NCT01683279 is a clinical study titled "A Pediatric Trial of Genetically Modified Autologous T Cells Directed Against CD19 for Relapsed CD19+ Acute Lymphoblastic Leukemia". Patients with relapsed leukemia often develop resistance to chemotherapy. For this reason, we are attempting to use a patient's own T cells, which can be genetically modified to expresses a chimeric antigen receptor(CAR). The CAR enables the T cell to recognize and kill the leukemic cells though the...

What is the current status of trial NCT01683279?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2012-03-25. Estimated completion is 2030-01-07.

What conditions does trial NCT01683279 study?

This clinical trial studies the following conditions: B-cell Leukemia.

What interventions are being tested in trial NCT01683279?

The interventions under investigation include: Autologous CD19 CAR+ EGFTt + T cells (BIOLOGICAL).

Who is sponsoring clinical trial NCT01683279?

This trial is sponsored by Seattle Children's Hospital, which has 168 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01683279 being conducted?

This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

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Source: ClinicalTrials.gov NCT01683279, the US trial registry maintained by the National Library of Medicine. NCT01683279 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.