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NCT01088984 · OUTCOME

Duration of Response (DOR)

Study of Bendamustine Hydrochloride for the Treatment of Pediatric Patients With Relapsed or Refractory Acute Leukemia · Source last updated 2016-05-23

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

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
At each treatment cycle (21 to 35 days), for a maximum of 12 cycles

What was measured

DOR was determined for the participants with CR or CRp in the primary analysis set, defined as the time from first achieving remission to the time when progression was diagnosed, the participant died, or the participant started receiving new antineoplastic therapy. Data from participants who do not progress were censored at the last valid assessments. Median DOR and its 95% confidence interval was determined based on the Kaplan-Meier method. Data from participants who received a transplant were censored at the time of the transplant.

Analysis population: No duration of remission (defined as CR or CRp) analysis was performed for participants in the primary analysis since none achieved remission.

Groups in this outcome

Phase 2: Bendamustine 120 mg/m^2

Bendamustine 120 mg/m\^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (Cycles 2 through 12), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.

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

Analysis denominator · Participants

GroupSource count
Phase 2: Bendamustine 120 mg/m^20

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    units
    Participants
description
DOR was determined for the participants with CR or CRp in the primary analysis set, defined as the time from first achieving remission to the time when progression was diagnosed, the participant died, or the participant started receiving new antineoplastic therapy. Data from participants who do not progress were censored at the last valid assessments. Median DOR and its 95% confidence interval was determined based on the Kaplan-Meier method. Data from participants who received a transplant were censored at the time of the transplant.
groups
  1. description
    Bendamustine 120 mg/m\^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (Cycles 2 through 12), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
    id
    OG000
    title
    Phase 2: Bendamustine 120 mg/m^2
population Description
No duration of remission (defined as CR or CRp) analysis was performed for participants in the primary analysis since none achieved remission.
reporting Status
POSTED
time Frame
At each treatment cycle (21 to 35 days), for a maximum of 12 cycles
title
Duration of Response (DOR)
type
SECONDARY

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

Preserved source evidence · Not medical advice