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NCT03734601 · OUTCOME

Full-dose Donor Chimerism (FDC) at Day 28 Following TLI/ATG/TBI Conditioning.

Total Body Irradiation +/- Total Lymphoid Irradiation & Anti-Thymocyte Globulin in Non-myeloablative Hematopoietic Cell Transplantation · Source last updated 2023-12-12

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 28

What was measured

Subsequent to TLI/ATG/TBI conditioning, the proportion of participants with full dose donor chimerism (FDC) will be determined by Day 28. FDC is defined as achieving ≥ 95% donor type in the CD3+ lineage within 28 days of donor cell infusion, as assessed by short tandem repeat (STR) testing. The outcome will be expressed as the number of participants that achieve FDC by Day 28, a number without dispersion.

Groups in this outcome

TBI+TLI

TBI, single exposure on Day -1, 80 centigray (cGy) in addition to total lymphoid irradiation (TLI, 120 cGy/day for 9 days, weekends excluded) and anti-thymocyte globulin (ATG) 1.5 mg/kg (conditioning regimen) Total body irradiation (TBI): Administer Total body irradiation (TBI) 80 cGy on Day 1 of standard TLI ATG conditioning Anti-thymocyte globulin (ATG): Given intravenous (IV), Dose 1.5 mg/kg x 5 days Tacrolimus: Oral, Dose 0.05 mg/kg twice daily, can be given intravenous (IV) Mycophenolate mofetil (MMF): Given Oral, 15 mg/k every 2 hours for peripheral blood stem cells (PBSC) from matched related donors; 15 mg/kg every 8 hours for PBSC from unrelated donors (URDs) or mismatched related donors. Total lymphoid irradiation (TLI): 9 x 120 cGy over 11 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
TBI+TLI22

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TBI+TLI13Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        13
denoms
  1. counts
    1. group Id
      OG000
      value
      22
    units
    Participants
description
Subsequent to TLI/ATG/TBI conditioning, the proportion of participants with full dose donor chimerism (FDC) will be determined by Day 28. FDC is defined as achieving ≥ 95% donor type in the CD3+ lineage within 28 days of donor cell infusion, as assessed by short tandem repeat (STR) testing. The outcome will be expressed as the number of participants that achieve FDC by Day 28, a number without dispersion.
groups
  1. description
    TBI, single exposure on Day -1, 80 centigray (cGy) in addition to total lymphoid irradiation (TLI, 120 cGy/day for 9 days, weekends excluded) and anti-thymocyte globulin (ATG) 1.5 mg/kg (conditioning regimen) Total body irradiation (TBI): Administer Total body irradiation (TBI) 80 cGy on Day 1 of standard TLI ATG conditioning Anti-thymocyte globulin (ATG): Given intravenous (IV), Dose 1.5 mg/kg x 5 days Tacrolimus: Oral, Dose 0.05 mg/kg twice daily, can be given intravenous (IV) Mycophenolate mofetil (MMF): Given Oral, 15 mg/k every 2 hours for peripheral blood stem cells (PBSC) from matched related donors; 15 mg/kg every 8 hours for PBSC from unrelated donors (URDs) or mismatched related donors. Total lymphoid irradiation (TLI): 9 x 120 cGy over 11 days
    id
    OG000
    title
    TBI+TLI
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Day 28
title
Full-dose Donor Chimerism (FDC) at Day 28 Following TLI/ATG/TBI Conditioning.
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice