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NCT00702403 · OUTCOME

The Proportion of Patients at 1 Year With Treatment Efficacy Success

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

To be considered a treatment efficacy success at 1 year posttransplant, the patient's bone marrow must demonstrate complete hematological remission, absence of Philadelphia chromosomes, and not satisfy any of the criteria for treatment failure (\>/= 1% aberrantly expressing marrow blasts by multiparameter flow cytometry, \>5% BCR/ABL in marrow by fluorescent in situ hybridization, or \>1 log rise in peripheral blood BCR/ABL by quantitative polymerase chain reaction (PCR) since day 80).

Analysis population: The analysis population was considered in two ways: first the number of treatment success in the entire cohort (by "intention to treat"), and second the number of treatment successes among only those patients who did not die before 1 year from non-relapse mortality.

Groups in this outcome

Treatment (Prophylactic Inhibition of BCR-ABL Tyrosine Kinase)

Beginning after engraftment and blood count recovery (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 count recovery 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
Treatment (Prophylactic Inhibition of BCR-ABL Tyrosine Kinase)40

Reported measurements

By intention to treat

Analysis denominator · Participants

GroupSource count
Treatment (Prophylactic Inhibition of BCR-ABL Tyrosine Kinase)40
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Prophylactic Inhibition of BCR-ABL Tyrosine Kinase)29Not reportedNot reportedNot reportedNot reported
Excluding early non-relapse deaths

Analysis denominator · Participants

GroupSource count
Treatment (Prophylactic Inhibition of BCR-ABL Tyrosine Kinase)34
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Prophylactic Inhibition of BCR-ABL Tyrosine Kinase)29Not 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
    title
    By intention to treat
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        29
    denoms
    1. counts
      1. group Id
        OG000
        value
        34
      units
      Participants
    title
    Excluding early non-relapse deaths
denoms
  1. counts
    1. group Id
      OG000
      value
      40
    units
    Participants
description
To be considered a treatment efficacy success at 1 year posttransplant, the patient's bone marrow must demonstrate complete hematological remission, absence of Philadelphia chromosomes, and not satisfy any of the criteria for treatment failure (\>/= 1% aberrantly expressing marrow blasts by multiparameter flow cytometry, \>5% BCR/ABL in marrow by fluorescent in situ hybridization, or \>1 log rise in peripheral blood BCR/ABL by quantitative polymerase chain reaction (PCR) since day 80).
groups
  1. description
    Beginning after engraftment and blood count recovery (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 count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Treatment (Prophylactic Inhibition of BCR-ABL Tyrosine Kinase)
param Type
COUNT_OF_PARTICIPANTS
population Description
The analysis population was considered in two ways: first the number of treatment success in the entire cohort (by "intention to treat"), and second the number of treatment successes among only those patients who did not die before 1 year from non-relapse mortality.
reporting Status
POSTED
time Frame
Up to 1 year
title
The Proportion of Patients at 1 Year With Treatment Efficacy Success
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice