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NCT01518153 · OUTCOME

Overall Survival (OS)

Planned Donor Lymphocyte Infusion (DLI) After Allogeneic Stem Cell Transplantation (SCT) · Source last updated 2016-03-17

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

Measure
MEDIAN
Unit
days
Interval / dispersion
Full Range
Time frame
Every 3 months until day of death

What was measured

Overall Survival is defined as the interval between day of transplant and day of death.

Analysis population: Sixteen participants have been treated on study and were evaluable for treatment response. Out of 16, 7 participants met the criteria to receive planned DLI.

Groups in this outcome

Stem Cell Transplant + Donor Lymphocyte Infusion

Fludarabine 40 mg/m\^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m\^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 1 x 10\^6 CD3+ cells/kg or 3 x 10\^6 CD3+ cells/kg between Day +56 \& +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m\^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)\> 500\*10/L for 3 consecutive days.

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

Analysis denominator · Participants

GroupSource count
Stem Cell Transplant + Donor Lymphocyte Infusion16

Reported measurements

Source class 1
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Stem Cell Transplant + Donor Lymphocyte Infusion246Not reported26504Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        26
        upper Limit
        504
        value
        246
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    units
    Participants
description
Overall Survival is defined as the interval between day of transplant and day of death.
dispersion Type
Full Range
groups
  1. description
    Fludarabine 40 mg/m\^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m\^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 1 x 10\^6 CD3+ cells/kg or 3 x 10\^6 CD3+ cells/kg between Day +56 \& +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m\^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)\> 500\*10/L for 3 consecutive days.
    id
    OG000
    title
    Stem Cell Transplant + Donor Lymphocyte Infusion
param Type
MEDIAN
population Description
Sixteen participants have been treated on study and were evaluable for treatment response. Out of 16, 7 participants met the criteria to receive planned DLI.
reporting Status
POSTED
time Frame
Every 3 months until day of death
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice