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NCT01116232 · OUTCOME

Incidence of Thrombotic Microangiopathy

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
Within 100 days of HCT

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

GroupSource 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
  1. counts
    1. group Id
      OG000
      value
      0
    units
    Participants
groups
  1. 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
Within 100 days of HCT
title
Incidence of Thrombotic Microangiopathy
type
SECONDARY

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

Preserved source evidence · Not medical advice