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NCT00577278 · OUTCOME

Relapse/Progression Rate at Two Years

A Phase II Study of Allo-HCT for B-Cell NHL Using Zevalin, Fludarabine and Melphalan · Source last updated 2024-02-16

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

Measure
NUMBER
Unit
percentage of cumulative incidence
Interval / dispersion
95% Confidence Interval
Time frame
From the initial treatment to the last disease assessment, up to two years

What was measured

The primary endpoint was 2-year cumulative incidence of relapse/progression (RP), defined as time from alloHCT to disease recurrence or progression. Cumulative incidences for RP was generated in a competing-risk setting, given that death events were competing events.

Groups in this outcome

0.4 mCi 90Y-Ibritumomab Tiuxetan

Patients receive rituximab IV followed by indium In-111 ibritumomab tiuxetan IV over 10 minutes on day -21 and rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day -14. Patients also receive fludarabine phosphate IV on days -9 to -5 and melphalan IV on day -4. Patients undergo APBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO and sirolimus PO beginning on day -3 and continuing for up to 6 months with taper. rituximab: Given IV fludarabine phosphate: Given IV melphalan: Given IV sirolimus: Given PO tacrolimus: Given PO or IV allogeneic hematopoietic stem cell transplantation: Undergo APBSCT indium In 111 ibritumomab tiuxetan: Given IV yttrium Y 90 ibritumomab tiuxetan: Given IV

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

Analysis denominator · Participants

GroupSource count
0.4 mCi 90Y-Ibritumomab Tiuxetan41

Reported measurements

Source class 1
Values in percentage of cumulative incidence · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
0.4 mCi 90Y-Ibritumomab Tiuxetan20Not reported1036Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        10
        upper Limit
        36
        value
        20
denoms
  1. counts
    1. group Id
      OG000
      value
      41
    units
    Participants
description
The primary endpoint was 2-year cumulative incidence of relapse/progression (RP), defined as time from alloHCT to disease recurrence or progression. Cumulative incidences for RP was generated in a competing-risk setting, given that death events were competing events.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive rituximab IV followed by indium In-111 ibritumomab tiuxetan IV over 10 minutes on day -21 and rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day -14. Patients also receive fludarabine phosphate IV on days -9 to -5 and melphalan IV on day -4. Patients undergo APBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO and sirolimus PO beginning on day -3 and continuing for up to 6 months with taper. rituximab: Given IV fludarabine phosphate: Given IV melphalan: Given IV sirolimus: Given PO tacrolimus: Given PO or IV allogeneic hematopoietic stem cell transplantation: Undergo APBSCT indium In 111 ibritumomab tiuxetan: Given IV yttrium Y 90 ibritumomab tiuxetan: Given IV
    id
    OG000
    title
    0.4 mCi 90Y-Ibritumomab Tiuxetan
param Type
NUMBER
reporting Status
POSTED
time Frame
From the initial treatment to the last disease assessment, up to two years
title
Relapse/Progression Rate at Two Years
type
PRIMARY
unit Of Measure
percentage of cumulative incidence

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

Preserved source evidence · Not medical advice