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NCT02556931 · OUTCOME

Percentage of Participants Who Are Able to Stop Prophylactic Tacrolimus (D60 Cohort)

Shorter Course Tacro After NMA, Related Donor PBSCT With High-dose Posttransplant Cy for Hard-to-Engraft Malignancies · Source last updated 2022-11-03

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
Day 60

What was measured

This outcome measures the feasibility of stopping prophylactic tacrolimus at Day 60.

Analysis population: Of the 42 patients in the D60 cohort who stopped IS early as prespecified, 10 subsequently relapsed.

Groups in this outcome

PBSCT D60

Non-myeloablative peripheral blood stem cell transplant (PBSCT) with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Tacrolimus will be stopped at either Day 60 or Day 180 depending on GVHD status. Fludarabine: Days -6 through -2: 30 mg/m\^2 IV daily Cyclophosphamide: Days -6 and -5: 14.5 mg/kg IV daily Days 3 and 4: 50 mg/kg IV daily Total body irradiation: Day -1: 200 cGy in a single fraction Tacrolimus: Start on Day 5 through either Day 60 or Day 90 depending on cohort assignment. May be continued through Day 180 depending on GVHD status. Mycophenolate mofetil: Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)

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

Analysis denominator · Participants

GroupSource count
PBSCT D6060

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PBSCT D6042Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        42
denoms
  1. counts
    1. group Id
      OG000
      value
      60
    units
    Participants
description
This outcome measures the feasibility of stopping prophylactic tacrolimus at Day 60.
groups
  1. description
    Non-myeloablative peripheral blood stem cell transplant (PBSCT) with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Tacrolimus will be stopped at either Day 60 or Day 180 depending on GVHD status. Fludarabine: Days -6 through -2: 30 mg/m\^2 IV daily Cyclophosphamide: Days -6 and -5: 14.5 mg/kg IV daily Days 3 and 4: 50 mg/kg IV daily Total body irradiation: Day -1: 200 cGy in a single fraction Tacrolimus: Start on Day 5 through either Day 60 or Day 90 depending on cohort assignment. May be continued through Day 180 depending on GVHD status. Mycophenolate mofetil: Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)
    id
    OG000
    title
    PBSCT D60
param Type
COUNT_OF_PARTICIPANTS
population Description
Of the 42 patients in the D60 cohort who stopped IS early as prespecified, 10 subsequently relapsed.
reporting Status
POSTED
time Frame
Day 60
title
Percentage of Participants Who Are Able to Stop Prophylactic Tacrolimus (D60 Cohort)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice