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NCT02003625 · OUTCOME

Number of Participants That Received Red Blood Cell and Platelet Transfusions Prior to Engraftment

Meloxicam vs Placebo for Mobilization · Source last updated 2020-05-18

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
Up to 6 months after transplantation ( up to 66-72 days after the start of treatment)

Analysis population: Number of transfusions needed were only counted among patients that underwent transplantation

Groups in this outcome

A. GCSF + Placebo

GCSF + Placebo Patients in this group will receive GCSF 10 ug/kg s.c. daily, beginning 4 days prior to the 1st apheresis \[days -4, -3, -2, -1\] and continued on daily GCSF for a total of 4 apheresis or until ≥ 5 x 10\^6 CD34+ cells/kg are collected. They will also receive oral placebo for 5 days on days -6 through -2. Patients will undergo apheresis for 300 minutes to achieve approximately 3 to 4 whole blood volumes processed. This is a standard institutional protocol for autologous HSPC collection at the MGH. GCSF Placebo

B. GCSF + Meloxicam

B. GCSF + meloxicam: Patients in this group will be treated with meloxicam and GCSF in an approximate two-day staggered dose schedule as described in our preclinical studies. Meloxicam will be given orally at a dose of 15 mg/day for 5 days (days -6 through -2). GCSF at 10 ug/kg/day subcutaneously will be started on day -4 and continued daily for a total of 4 apheresis or until ≥ 5 x 10\^6 CD34+ cells/kg are collected. GCSF meloxicam

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

Analysis denominator · Participants

GroupSource count
A. GCSF + Placebo14
B. GCSF + Meloxicam12

Reported measurements

Platelet transfusions
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A. GCSF + Placebo14Not reportedNot reportedNot reportedNot reported
B. GCSF + Meloxicam9Not reportedNot reportedNot reportedNot reported
Red blood cell transfusions
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A. GCSF + Placebo6Not reportedNot reportedNot reportedNot reported
B. GCSF + Meloxicam3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        14
      2. group Id
        OG001
        value
        9
    title
    Platelet transfusions
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        3
    title
    Red blood cell transfusions
denoms
  1. counts
    1. group Id
      OG000
      value
      14
    2. group Id
      OG001
      value
      12
    units
    Participants
groups
  1. description
    GCSF + Placebo Patients in this group will receive GCSF 10 ug/kg s.c. daily, beginning 4 days prior to the 1st apheresis \[days -4, -3, -2, -1\] and continued on daily GCSF for a total of 4 apheresis or until ≥ 5 x 10\^6 CD34+ cells/kg are collected. They will also receive oral placebo for 5 days on days -6 through -2. Patients will undergo apheresis for 300 minutes to achieve approximately 3 to 4 whole blood volumes processed. This is a standard institutional protocol for autologous HSPC collection at the MGH. GCSF Placebo
    id
    OG000
    title
    A. GCSF + Placebo
  2. description
    B. GCSF + meloxicam: Patients in this group will be treated with meloxicam and GCSF in an approximate two-day staggered dose schedule as described in our preclinical studies. Meloxicam will be given orally at a dose of 15 mg/day for 5 days (days -6 through -2). GCSF at 10 ug/kg/day subcutaneously will be started on day -4 and continued daily for a total of 4 apheresis or until ≥ 5 x 10\^6 CD34+ cells/kg are collected. GCSF meloxicam
    id
    OG001
    title
    B. GCSF + Meloxicam
param Type
COUNT_OF_PARTICIPANTS
population Description
Number of transfusions needed were only counted among patients that underwent transplantation
reporting Status
POSTED
time Frame
Up to 6 months after transplantation ( up to 66-72 days after the start of treatment)
title
Number of Participants That Received Red Blood Cell and Platelet Transfusions Prior to Engraftment
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice