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NCT00698685 · OUTCOME

Non-relapse Mortality at or Before Day 100

Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic Peripheral Blood Stem Cell Transplantation · Source last updated 2017-03-31

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

Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
Day 100 after transplant

What was measured

The primary safety outcome is indicated by the number of participants who died at or before Day 100 after transplant for any reason other than relapse of disease (Leukemia, Lymphoma, Hodgkin's disease, Hematologic Neoplasms, Multiple Myeloma, Renal Cell Carcinoma).

Analysis population: All participants who received at least 1 day of treatment.

Groups in this outcome

Preparative Regimen of Pentostatin and Alemtuzumab

Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic \[related or unrelated\] Hematopoietic SCT. Pentostatin: 4 mg/m2/24 hour IV continuously over 72 hours on days -8 to -6. Alemtuzumab: 20 mg per dose IV over 8 hours on days -5 to -1. Patients then received infusion of related or unrelated donor peripheral blood progenitor cells on day 0. Patients also receive cyclosporine IV continuously beginning on day -2, continuing (IV or orally) until day 100, followed by a taper.

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

Analysis denominator · Participants

GroupSource count
Preparative Regimen of Pentostatin and Alemtuzumab13

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Preparative Regimen of Pentostatin and Alemtuzumab3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    units
    Participants
description
The primary safety outcome is indicated by the number of participants who died at or before Day 100 after transplant for any reason other than relapse of disease (Leukemia, Lymphoma, Hodgkin's disease, Hematologic Neoplasms, Multiple Myeloma, Renal Cell Carcinoma).
groups
  1. description
    Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic \[related or unrelated\] Hematopoietic SCT. Pentostatin: 4 mg/m2/24 hour IV continuously over 72 hours on days -8 to -6. Alemtuzumab: 20 mg per dose IV over 8 hours on days -5 to -1. Patients then received infusion of related or unrelated donor peripheral blood progenitor cells on day 0. Patients also receive cyclosporine IV continuously beginning on day -2, continuing (IV or orally) until day 100, followed by a taper.
    id
    OG000
    title
    Preparative Regimen of Pentostatin and Alemtuzumab
param Type
NUMBER
population Description
All participants who received at least 1 day of treatment.
reporting Status
POSTED
time Frame
Day 100 after transplant
title
Non-relapse Mortality at or Before Day 100
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice