NCT00702403 · OUTCOME

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: 1 and 3 years

What was measured

The proportion of patients with hematologic, cytogenetic or molecular relapse of BCR/ABL-positive leukemia

Analysis population: Proportion of patients with hematologic, cytogenetic or molecular relapse of BCR/ABL-positive leukemia among those who did not die from non-relapse causes during the first year, and first 3-years after transplant.

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

Group	Source count
Treatment (Prophylactic Inhibition of BCR-ABL Tyrosine Kinase)	40

Reported measurements

Proportion with relapse at 1 year

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Prophylactic Inhibition of BCR-ABL Tyrosine Kinase)	5	Not reported	Not reported	Not reported	Not reported

Proportion with relapse at 3 years

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Prophylactic Inhibition of BCR-ABL Tyrosine Kinase)	6	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
5
title
Proportion with relapse at 1 year
categories
measurements
group Id
OG000
value
6
title
Proportion with relapse at 3 years

denoms

counts
group Id
OG000
value
40
units
Participants

description

The proportion of patients with hematologic, cytogenetic or molecular relapse of BCR/ABL-positive leukemia

groups

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

Proportion of patients with hematologic, cytogenetic or molecular relapse of BCR/ABL-positive leukemia among those who did not die from non-relapse causes during the first year, and first 3-years after transplant.

reporting Status

POSTED

time Frame

1 and 3 years

title

Relapse

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice