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NCT02259348 · OUTCOME

Percentage of Participants Engrafted by Day 42 Post-transplant

Repeat Transplantation for Relapsed or Refractory Hematologic Malignancies Following Prior Transplantation · Source last updated 2017-05-30

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
Day 42 post transplantation

What was measured

To estimate engraftment by day +42 post-transplant in patients who receive CD45RA-depleted haploidentical donor progenitor cell transplantation following reduced intensity conditioning regimen that includes haploidentical NK cells. Engraftment is defined as the first of 3 consecutive tests performed on different days of an ANC ≥ 500/mm\^3 with evidence of donor cell engraftment.

Groups in this outcome

Participants

Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level. Cyclophosphamide: Given intravenously (IV) Fludarabine: Given IV G-CSF: Given IV or subcutaneously (SQ) Interleukin-2: Given SQ Melphalan: Given IV Thiotepa: Given IV Rituximab: Given IV Natural killer cell therapy: Given IV T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0. CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1.

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

Analysis denominator · Participants

GroupSource count
Participants6

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Participants100Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        100
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    units
    Participants
description
To estimate engraftment by day +42 post-transplant in patients who receive CD45RA-depleted haploidentical donor progenitor cell transplantation following reduced intensity conditioning regimen that includes haploidentical NK cells. Engraftment is defined as the first of 3 consecutive tests performed on different days of an ANC ≥ 500/mm\^3 with evidence of donor cell engraftment.
groups
  1. description
    Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level. Cyclophosphamide: Given intravenously (IV) Fludarabine: Given IV G-CSF: Given IV or subcutaneously (SQ) Interleukin-2: Given SQ Melphalan: Given IV Thiotepa: Given IV Rituximab: Given IV Natural killer cell therapy: Given IV T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0. CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1.
    id
    OG000
    title
    Participants
param Type
NUMBER
reporting Status
POSTED
time Frame
Day 42 post transplantation
title
Percentage of Participants Engrafted by Day 42 Post-transplant
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice