NCT03246906 · OUTCOME

Number of Patients With Late Graft Versus Host Disease (GVHD) Not Meeting National Institute of Health (NIH) Consensus Criteria for Chronic GVHD

Comparison of Triple GVHD Prophylaxis Regimens for Nonmyeloablative or Reduced Intensity Conditioning Unrelated Mobilized Blood Cell Transplantation · Source last updated 2026-05-14

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 1 year post-HCT

What was measured

GVHD occurring after day 100 and not meeting NIH consensus criteria for chronic GVHD. Estimated by cumulative incidence methods.

Groups in this outcome

Arm I (Mycophenolate Mofetil, Cyclosporine, Sirolimus)

Patients undergo allogeneic HCT at day 0. Patients with an HLA-matched unrelated donor receive mycophenolate mofetil PO on days 0 to 40, cyclosporine PO every 12 hours BID on days -3 to 96 then tapered to day 150, and sirolimus PO QD on days -3 to day 150 then tapered to day 180. Patients with an HLA-mismatched donor receive mycophenolate mofetil PO on days 0-100 then tapered to day 150, cyclosporine PO BID on days -3 to 150 then tapered to day 180, and sirolimus PO QD on days -3 to 180 then tapered to day 365. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HCT Cyclosporine: Given PO Mycophenolate Mofetil: Given PO Sirolimus: Given PO

Arm II (Cyclosporine, Sirolimus, Cyclophosphamide)

Patients undergo HCT at day 0. Patients with an HLA-matched unrelated donor receive cyclosporine PO BID on days 5-96 then tapered to day 150, sirolimus PO QD on days 5-150 then tapered to day 180, and cyclophosphamide IV on days 3 and 4. Patients with an HLA-mismatched donor receive cyclosporine PO BID on days 5-150 then tapered to day 180, sirolimus PO QD on days 5-180 then tapered to day 365, and cyclophosphamide IV on days 3 and 4. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HCT Cyclophosphamide: Given IV Cyclosporine: Given PO Sirolimus: Given PO

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

Analysis denominator · Participants

Group	Source count
Arm I (Mycophenolate Mofetil, Cyclosporine, Sirolimus)	73
Arm II (Cyclosporine, Sirolimus, Cyclophosphamide)	72

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Mycophenolate Mofetil, Cyclosporine, Sirolimus)	2	Not reported	Not reported	Not reported	Not reported
Arm II (Cyclosporine, Sirolimus, Cyclophosphamide)	4	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
2
group Id
OG001
value
4

denoms

counts
group Id
OG000
value
73
group Id
OG001
value
72
units
Participants

description

GVHD occurring after day 100 and not meeting NIH consensus criteria for chronic GVHD. Estimated by cumulative incidence methods.

groups

description
Patients undergo allogeneic HCT at day 0. Patients with an HLA-matched unrelated donor receive mycophenolate mofetil PO on days 0 to 40, cyclosporine PO every 12 hours BID on days -3 to 96 then tapered to day 150, and sirolimus PO QD on days -3 to day 150 then tapered to day 180. Patients with an HLA-mismatched donor receive mycophenolate mofetil PO on days 0-100 then tapered to day 150, cyclosporine PO BID on days -3 to 150 then tapered to day 180, and sirolimus PO QD on days -3 to 180 then tapered to day 365. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HCT Cyclosporine: Given PO Mycophenolate Mofetil: Given PO Sirolimus: Given PO
id
OG000
title
Arm I (Mycophenolate Mofetil, Cyclosporine, Sirolimus)
description
Patients undergo HCT at day 0. Patients with an HLA-matched unrelated donor receive cyclosporine PO BID on days 5-96 then tapered to day 150, sirolimus PO QD on days 5-150 then tapered to day 180, and cyclophosphamide IV on days 3 and 4. Patients with an HLA-mismatched donor receive cyclosporine PO BID on days 5-150 then tapered to day 180, sirolimus PO QD on days 5-180 then tapered to day 365, and cyclophosphamide IV on days 3 and 4. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HCT Cyclophosphamide: Given IV Cyclosporine: Given PO Sirolimus: Given PO
id
OG001
title
Arm II (Cyclosporine, Sirolimus, Cyclophosphamide)

param Type

COUNT_OF_PARTICIPANTS

reporting Status

POSTED

time Frame

At 1 year post-HCT

title

Number of Patients With Late Graft Versus Host Disease (GVHD) Not Meeting National Institute of Health (NIH) Consensus Criteria for Chronic GVHD

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice