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NCT01780662 · OUTCOME

The Number of Patients Who Had Successful Peripheral Blood Stem Cell (PBSC) Collection

Brentuximab Vedotin and Gemcitabine Hydrochloride in Treating Younger Patients With Relapsed or Refractory Hodgkin Lymphoma · Source last updated 2021-10-28

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
From 1 to 5 cycles

What was measured

Successful PBSC collection was defined as a collection of more than 2x10\^6 CD34 positive cells.

Analysis population: For 21 of the eligible 45 subjects, PBSC collection was not attempted during protocol therapy, either because stem cells had been collected prior to study enrollment, or no autologous stem cell transplant was planned. 1 patient was ineligible due to exceeding the prescribed interval between disease evaluation and study entry.

Groups in this outcome

Treatment (Brentuximab Vedotin, Gemcitabine Hydrochloride)

Patients receive brentuximab vedotin IV over 30 minutes on day 1 and gemcitabine hydrochloride IV over 100 minutes on days 1 and 8. Treatment repeats every 21 days for up to 15 more courses in the absence of disease progression or unacceptable toxicity. Patients with CR after any course may go off protocol therapy for stem cell transplant. Brentuximab Vedotin: Given IV Gemcitabine Hydrochloride: 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
Treatment (Brentuximab Vedotin, Gemcitabine Hydrochloride)24

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Brentuximab Vedotin, Gemcitabine Hydrochloride)24Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        24
denoms
  1. counts
    1. group Id
      OG000
      value
      24
    units
    Participants
description
Successful PBSC collection was defined as a collection of more than 2x10\^6 CD34 positive cells.
groups
  1. description
    Patients receive brentuximab vedotin IV over 30 minutes on day 1 and gemcitabine hydrochloride IV over 100 minutes on days 1 and 8. Treatment repeats every 21 days for up to 15 more courses in the absence of disease progression or unacceptable toxicity. Patients with CR after any course may go off protocol therapy for stem cell transplant. Brentuximab Vedotin: Given IV Gemcitabine Hydrochloride: Given IV
    id
    OG000
    title
    Treatment (Brentuximab Vedotin, Gemcitabine Hydrochloride)
param Type
COUNT_OF_PARTICIPANTS
population Description
For 21 of the eligible 45 subjects, PBSC collection was not attempted during protocol therapy, either because stem cells had been collected prior to study enrollment, or no autologous stem cell transplant was planned. 1 patient was ineligible due to exceeding the prescribed interval between disease evaluation and study entry.
reporting Status
POSTED
time Frame
From 1 to 5 cycles
title
The Number of Patients Who Had Successful Peripheral Blood Stem Cell (PBSC) Collection
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice