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NCT02028455 · OUTCOME

Number of Participants With an MRD Negative Complete Remission After Initial CAR T Cell Infusion

A Pediatric and Young Adult Trial of Genetically Modified T Cells Directed Against CD19 for Relapsed/Refractory CD19+ Leukemia · Source last updated 2026-08-06

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Initial CAR T cell infusion through Day 63 post infusion assessment (+/- 14 days)

What was measured

The efficacy of the T cell infusion will be estimated based on the number of participants who have an MRD negative bone marrow aspirate following the initial T cell infusion

Analysis population: Efficacy-evaluable leukemia patients in Phase 2, plus Phase 1 patients treated at the Phase 2 dose in cohort 1F2, who received SCRIv1 or SCRIv1.5 CAR T cells following prescribed lymphodepletion with fludarabine and cyclophosphamide

Groups in this outcome

SCRI-CAR19v1/v1.5 Efficacy-evaluable Leukemia Cohort

Efficacy-evaluable leukemia patients who received SCRIv1 or SCRIv1.5 CAR T cells

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
SCRI-CAR19v1/v1.5 Efficacy-evaluable Leukemia Cohort71

Reported measurements

Source class 1

Number of Participants with an MRD Negative Complete Remission after Initial CAR T Infusion

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SCRI-CAR19v1/v1.5 Efficacy-evaluable Leukemia Cohort63Not reportedNot reportedNot reportedNot reported

Number of Participants without an MRD Negative Complete Remission after Initial CAR T Infusion

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SCRI-CAR19v1/v1.5 Efficacy-evaluable Leukemia Cohort8Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        63
      title
      Number of Participants with an MRD Negative Complete Remission after Initial CAR T Infusion
    2. measurements
      1. group Id
        OG000
        value
        8
      title
      Number of Participants without an MRD Negative Complete Remission after Initial CAR T Infusion
denoms
  1. counts
    1. group Id
      OG000
      value
      71
    units
    Participants
description
The efficacy of the T cell infusion will be estimated based on the number of participants who have an MRD negative bone marrow aspirate following the initial T cell infusion
groups
  1. description
    Efficacy-evaluable leukemia patients who received SCRIv1 or SCRIv1.5 CAR T cells
    id
    OG000
    title
    SCRI-CAR19v1/v1.5 Efficacy-evaluable Leukemia Cohort
param Type
COUNT_OF_PARTICIPANTS
population Description
Efficacy-evaluable leukemia patients in Phase 2, plus Phase 1 patients treated at the Phase 2 dose in cohort 1F2, who received SCRIv1 or SCRIv1.5 CAR T cells following prescribed lymphodepletion with fludarabine and cyclophosphamide
reporting Status
POSTED
time Frame
Initial CAR T cell infusion through Day 63 post infusion assessment (+/- 14 days)
title
Number of Participants With an MRD Negative Complete Remission After Initial CAR T Cell Infusion
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice