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NCT00075478 · OUTCOME

Incidence of Graft Rejection

Total-Body Irradiation With or Without Fludarabine Phosphate Followed By Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer · Source last updated 2017-05-15

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
1 year after transplant

What was measured

Donor CD3 chimerism less than 5%

Groups in this outcome

Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)

Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins. total-body irradiation: Undergo TBI fludarabine phosphate: Given IV mycophenolate mofetil: Given PO cyclosporine: Given PO peripheral blood stem cell transplantation: Undergo transplantation

Arm II (TBI, Transplant, GVHD Prophylaxis)

Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins. total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO cyclosporine: Given PO peripheral blood stem cell transplantation: Undergo transplantation

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

Analysis denominator · Participants

GroupSource count
Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)41
Arm II (TBI, Transplant, GVHD Prophylaxis)44

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)0Not reported00Not reported
Arm II (TBI, Transplant, GVHD Prophylaxis)2Not reported3131Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        0
        value
        0
      2. group Id
        OG001
        lower Limit
        31
        upper Limit
        31
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      41
    2. group Id
      OG001
      value
      44
    units
    Participants
description
Donor CD3 chimerism less than 5%
groups
  1. description
    Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins. total-body irradiation: Undergo TBI fludarabine phosphate: Given IV mycophenolate mofetil: Given PO cyclosporine: Given PO peripheral blood stem cell transplantation: Undergo transplantation
    id
    OG000
    title
    Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)
  2. description
    Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins. total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO cyclosporine: Given PO peripheral blood stem cell transplantation: Undergo transplantation
    id
    OG001
    title
    Arm II (TBI, Transplant, GVHD Prophylaxis)
param Type
NUMBER
reporting Status
POSTED
time Frame
1 year after transplant
title
Incidence of Graft Rejection
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice