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NCT00051311 · OUTCOME

Number of Recipients Who Developed Grades I-IV Acute Graft Versus Host Disease (GVHD) Following a Combination of Cyclosporine and a Mini-dose Methotrexate Regimen for Graft Versus Host Disease (GVHD) Prophylaxis

Modified Stem Cell Transplant Procedure to Treat Patients With Blood and Immune System Cancers · Source last updated 2021-09-09

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 least 100 days of follow-up post reduced-intensity stem cell transplantation (RIST)

What was measured

Here is the number of recipients who developed grades I-IV acute graft versus host disease (GVHD) following a combination of cyclosporine and a mini-dose methotrexate regimen for graft-versus-host disease (GVHD) prophylaxis. Grades I-IV acute GVHD clinical staging was assessed by the Glucksberg Criteria. Grade I-IV acute GVHD can occur in the skin, liver, and/or gut. Grade 1: rash \< 25% body surface area (BSA), total bilirubin 2-3 mg/dl, and diarrhea 500-1000 ml/d. Grade 2: 25-50% BSA, total bilirubin 3-6 mg/dl, and diarrhea 1000-1500 ml/d. Grade 3: generalized erythroderma, total bilirubin 6-15 mg/dl, and diarrhea \>1500 ml/d. Grade 4: desquamation and bullae, total bilirubin \>15 mg/dl, and pain +/- ileus.

Groups in this outcome

Recipient

Recipients will receive induction chemotherapy with fludarabine, cyclophosphamide, etoposide, doxorubicin, vincristine, and prednisone. (one cycle is 5 days on drug therapy followed by a 16 day rest period). Prior to the transplant procedure, recipients will receive conditioning therapy followed by the infusion of donor stem cells. Methotrexate: Recipients will receive 4 doses of methotrexate by vein after the transplant to help prevent graft-versus-host disease (GVHD). Cyclosporine: Recipients will receive cyclosporine by vein or by mouth for about 6 months after the transplant to help prevent graft-versus-host disease (GVHD).

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

Analysis denominator · Participants

GroupSource count
Recipient31

Reported measurements

Grade I GVHD
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Recipient1Not reportedNot reportedNot reportedNot reported
Grade II GVHD
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Recipient7Not reportedNot reportedNot reportedNot reported
Grade III GVHD
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Recipient6Not reportedNot reportedNot reportedNot reported
Grade IV GVHD
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Recipient0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade I GVHD
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        7
    title
    Grade II GVHD
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Grade III GVHD
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Grade IV GVHD
denoms
  1. counts
    1. group Id
      OG000
      value
      31
    units
    Participants
description
Here is the number of recipients who developed grades I-IV acute graft versus host disease (GVHD) following a combination of cyclosporine and a mini-dose methotrexate regimen for graft-versus-host disease (GVHD) prophylaxis. Grades I-IV acute GVHD clinical staging was assessed by the Glucksberg Criteria. Grade I-IV acute GVHD can occur in the skin, liver, and/or gut. Grade 1: rash \< 25% body surface area (BSA), total bilirubin 2-3 mg/dl, and diarrhea 500-1000 ml/d. Grade 2: 25-50% BSA, total bilirubin 3-6 mg/dl, and diarrhea 1000-1500 ml/d. Grade 3: generalized erythroderma, total bilirubin 6-15 mg/dl, and diarrhea \>1500 ml/d. Grade 4: desquamation and bullae, total bilirubin \>15 mg/dl, and pain +/- ileus.
groups
  1. description
    Recipients will receive induction chemotherapy with fludarabine, cyclophosphamide, etoposide, doxorubicin, vincristine, and prednisone. (one cycle is 5 days on drug therapy followed by a 16 day rest period). Prior to the transplant procedure, recipients will receive conditioning therapy followed by the infusion of donor stem cells. Methotrexate: Recipients will receive 4 doses of methotrexate by vein after the transplant to help prevent graft-versus-host disease (GVHD). Cyclosporine: Recipients will receive cyclosporine by vein or by mouth for about 6 months after the transplant to help prevent graft-versus-host disease (GVHD).
    id
    OG000
    title
    Recipient
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
At least 100 days of follow-up post reduced-intensity stem cell transplantation (RIST)
title
Number of Recipients Who Developed Grades I-IV Acute Graft Versus Host Disease (GVHD) Following a Combination of Cyclosporine and a Mini-dose Methotrexate Regimen for Graft Versus Host Disease (GVHD) Prophylaxis
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice