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NCT02000427 · OUTCOME

Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT) During Blinatumomab Induced Remission

Blinatumomab in Adults With Relapsed/Refractory Philadelphia Positive B-precursor Acute Lymphoblastic Leukemia · Source last updated 2024-05-28

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to the data cut-of date of 20 May 2015; Maximum duration on study was 14.5 months.

What was measured

Participants who achieved remission (CR/CRh\*) during the first 2 cycles of treatment and received an allogeneic HSCT.

Analysis population: Participants who received an infusion of blinatumomab and had a CR/CRh\* response during the first 2 cycles of treatment.

Groups in this outcome

Blinatumomab

Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab. The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment.

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

Analysis denominator · Participants

GroupSource count
Blinatumomab16

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Blinatumomab43.8Not reported19.870.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        19.8
        upper Limit
        70.1
        value
        43.8
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    units
    Participants
description
Participants who achieved remission (CR/CRh\*) during the first 2 cycles of treatment and received an allogeneic HSCT.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab. The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment.
    id
    OG000
    title
    Blinatumomab
param Type
NUMBER
population Description
Participants who received an infusion of blinatumomab and had a CR/CRh\* response during the first 2 cycles of treatment.
reporting Status
POSTED
time Frame
Up to the data cut-of date of 20 May 2015; Maximum duration on study was 14.5 months.
title
Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT) During Blinatumomab Induced Remission
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice