NCT01116232 · OUTCOME

Time to Engraftment

Sirolimus, Tacrolimus, Thymoglobulin and Rituximab as Graft-versus-Host-Disease Prophylaxis in Patients Undergoing Haploidentical and HLA Partially Matched Donor Hematopoietic Cell Transplantation · Source last updated 2019-03-26

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

Measure: Not reported
Unit: Not reported
Interval / dispersion: Not reported
Time frame: During the first six months post transplant

Analysis population: Study terminated due to lack of funding, no analysis was done for this protocol due to the fact that only four patients were accrued, no data was collected.

Groups in this outcome

Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,

Anti-thymocyte globulin infuse the 1st dose, minimum of 6 hrs subsequent doses minimum of 4 hrs via a 0.22 micron in-line filter Rituximab, total dose is 28 mg/kg divided in 2 doses (14 mg/kg, days -7 \& +3) Initial infusion, start rate 50 mg/hour Sirolimus 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC). Tacrolimus (IV) dose of 0.03 mg/kg (ideal body weight) every 24hr by continuous infusion starting on Day -3, discontinued once the pt. starts eating \& the drug will then be given orally at a dose of approximately 4 times the IV dose. .

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
Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,	0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields

denoms

counts
group Id
OG000
value
0
units
Participants

groups

description
Anti-thymocyte globulin infuse the 1st dose, minimum of 6 hrs subsequent doses minimum of 4 hrs via a 0.22 micron in-line filter Rituximab, total dose is 28 mg/kg divided in 2 doses (14 mg/kg, days -7 \& +3) Initial infusion, start rate 50 mg/hour Sirolimus 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC). Tacrolimus (IV) dose of 0.03 mg/kg (ideal body weight) every 24hr by continuous infusion starting on Day -3, discontinued once the pt. starts eating \& the drug will then be given orally at a dose of approximately 4 times the IV dose. .
id
OG000
title
Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,

population Description

Study terminated due to lack of funding, no analysis was done for this protocol due to the fact that only four patients were accrued, no data was collected.

reporting Status

POSTED

time Frame

During the first six months post transplant

title

Time to Engraftment

type

PRIMARY

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

Preserved source evidence · Not medical advice