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NCT01231412 · OUTCOME

Number of Patients With Grades II-IV Acute GVHD

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
At day 100 post-transplant

What was measured

Number of patients with grades II-IV acute GVHD aGVHD Stages Skin: 1. a maculopapular eruption involving \< 25% BSA 2. a maculopapular eruption involving 25 - 50% BSA 3. generalized erythroderma 4. generalized erythroderma w/ bullous formation and often w/ desquamation Liver: 1. bilirubin 2.0 - 3.0 mg/100 mL 2. bilirubin 3 - 5.9 mg/100 mL 3. bilirubin 6 - 14.9 mg/100 mL 4. bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients w/ visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 w/ extreme constitutional symptoms or death

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)39Not reportedNot reportedNot reportedNot reported
Arm II (MMF, CSP, and Sirolimus)22Not reportedNot reportedNot reportedNot reported
Arm 0 (CSP and Sirolimus)3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        39
      2. group Id
        OG001
        value
        22
      3. group Id
        OG002
        value
        3
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 patients with grades II-IV acute GVHD aGVHD Stages Skin: 1. a maculopapular eruption involving \< 25% BSA 2. a maculopapular eruption involving 25 - 50% BSA 3. generalized erythroderma 4. generalized erythroderma w/ bullous formation and often w/ desquamation Liver: 1. bilirubin 2.0 - 3.0 mg/100 mL 2. bilirubin 3 - 5.9 mg/100 mL 3. bilirubin 6 - 14.9 mg/100 mL 4. bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients w/ visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 w/ extreme constitutional symptoms or death
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
At day 100 post-transplant
title
Number of Patients With Grades II-IV Acute GVHD
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice