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NCT01231412 · OUTCOME

Number of Non-Relapse Mortalities

Graft-Versus-Host Disease Prophylaxis in Treating Patients With Hematologic Malignancies Undergoing Unrelated Donor Peripheral Blood Stem Cell Transplant · Source last updated 2026-04-30

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
Up to 1 year

What was measured

Number of subjects expired without disease progression/relapse.

Analysis population: One subject on Arm II aborted transplant during conditioning and subsequently went on to transplant on a different study. This subject was counted towards accrual but not evaluated with respect to outcome measures.

Groups in this outcome

Arm I (MMF and CSP)

Patients receive FLU IV over 30 minutes on days -4 to -2. Patients also receive CSP PO BID on days -3 to 96 with taper to day 150 and MMF PO TID daily on days 0-29 and then BID on days 30-150 with taper to day 180. Patients undergo allogeneic PBSCT on day 0 following the TBI. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT Cyclosporine: Given PO or IV Fludarabine Phosphate: Given IV Mycophenolate Mofetil: Given PO Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT Total-Body Irradiation: Undergo TBI

Arm II (MMF, CSP, and Sirolimus)

Patients receive FLU and CSP as in Arm I and sirolimus PO QD on days -3 to 150 with taper to day 180. Patients also receive MMF PO TID on days 0-29 and then BID on days 30-40. MMF will then be discontinued without taper unless GVHD or disease relapse/progression occurs. Patients undergo allogeneic PBSCT on day 0 following the TBI. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT Cyclosporine: Given PO or IV Fludarabine Phosphate: Given IV Mycophenolate Mofetil: Given PO Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT Sirolimus: Given PO Total-Body Irradiation: Undergo TBI

Arm 0 (CSP and Sirolimus)

Patients receive CSP orally (PO) twice daily (BID) on days -3 to 96 with taper to day 150 and and sirolimus PO once daily (QD) on days -3 to 150 with taper to day 180. Arm removed as of 14-Sep-2011

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 (MMF and CSP)77
Arm II (MMF, CSP, and Sirolimus)90
Arm 0 (CSP and Sirolimus)6

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (MMF and CSP)12Not reportedNot reportedNot reportedNot reported
Arm II (MMF, CSP, and Sirolimus)4Not reportedNot reportedNot reportedNot reported
Arm 0 (CSP and Sirolimus)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      77
    2. group Id
      OG001
      value
      90
    3. group Id
      OG002
      value
      6
    units
    Participants
description
Number of subjects expired without disease progression/relapse.
groups
  1. description
    Patients receive FLU IV over 30 minutes on days -4 to -2. Patients also receive CSP PO BID on days -3 to 96 with taper to day 150 and MMF PO TID daily on days 0-29 and then BID on days 30-150 with taper to day 180. Patients undergo allogeneic PBSCT on day 0 following the TBI. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT Cyclosporine: Given PO or IV Fludarabine Phosphate: Given IV Mycophenolate Mofetil: Given PO Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT Total-Body Irradiation: Undergo TBI
    id
    OG000
    title
    Arm I (MMF and CSP)
  2. description
    Patients receive FLU and CSP as in Arm I and sirolimus PO QD on days -3 to 150 with taper to day 180. Patients also receive MMF PO TID on days 0-29 and then BID on days 30-40. MMF will then be discontinued without taper unless GVHD or disease relapse/progression occurs. Patients undergo allogeneic PBSCT on day 0 following the TBI. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT Cyclosporine: Given PO or IV Fludarabine Phosphate: Given IV Mycophenolate Mofetil: Given PO Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT Sirolimus: Given PO Total-Body Irradiation: Undergo TBI
    id
    OG001
    title
    Arm II (MMF, CSP, and Sirolimus)
  3. description
    Patients receive CSP orally (PO) twice daily (BID) on days -3 to 96 with taper to day 150 and and sirolimus PO once daily (QD) on days -3 to 150 with taper to day 180. Arm removed as of 14-Sep-2011
    id
    OG002
    title
    Arm 0 (CSP and Sirolimus)
param Type
COUNT_OF_PARTICIPANTS
population Description
One subject on Arm II aborted transplant during conditioning and subsequently went on to transplant on a different study. This subject was counted towards accrual but not evaluated with respect to outcome measures.
reporting Status
POSTED
time Frame
Up to 1 year
title
Number of Non-Relapse Mortalities
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice