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NCT00702403 · OUTCOME

Patients Alive With Out Relapse

Nilotinib and Imatinib Mesylate After Donor Stem Cell Transplant in Treating Patients With ALL or CML · Source last updated 2017-08-10

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
Up to 1 year

What was measured

The proportion of study participants alive and without hematologic, cytogenetic or molecular evidence of BCR/ABL-positive leukemia at 1 year

Analysis population: Proportion alive without relapse among the total number of patients with minimal residual disease follow-up data

Groups in this outcome

Single Arm Nilotinib Relapse Prophylaxis

Beginning after engraftment and blood counts recover (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO once daily until day 80 and then nilotinib PO twice daily on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO twice daily beginning after engraftment and blood counts recover until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Single Arm Nilotinib Relapse Prophylaxis40

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Single Arm Nilotinib Relapse Prophylaxis29Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        29
denoms
  1. counts
    1. group Id
      OG000
      value
      40
    units
    Participants
description
The proportion of study participants alive and without hematologic, cytogenetic or molecular evidence of BCR/ABL-positive leukemia at 1 year
groups
  1. description
    Beginning after engraftment and blood counts recover (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO once daily until day 80 and then nilotinib PO twice daily on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO twice daily beginning after engraftment and blood counts recover until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Single Arm Nilotinib Relapse Prophylaxis
param Type
COUNT_OF_PARTICIPANTS
population Description
Proportion alive without relapse among the total number of patients with minimal residual disease follow-up data
reporting Status
POSTED
time Frame
Up to 1 year
title
Patients Alive With Out Relapse
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice