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NCT01118013 · OUTCOME

Comparison of EFS Distribution to That of CALGB-100002

Donor Stem Cell Transplant in Treating Patients With Relapsed Hematologic Malignancies or Secondary Myelodysplasia Previously Treated With High-Dose Chemotherapy and Autologous Stem Cell Transplant · Source last updated 2017-03-24

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
2 years

What was measured

EFS distributions between CALGB-100002 and this study will be compared using the two-sample log-rank test.

Analysis population: Due to study termination, data were not collected and the outcome measure was not analyzed.

Groups in this outcome

Treatment

Participants will receive: Busulfan test dose of 25 mg/m\^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m\^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m\^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC \> 1000/mL for 3 consecutive days.

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

Analysis denominator · Participants

GroupSource count
Treatment0

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
description
EFS distributions between CALGB-100002 and this study will be compared using the two-sample log-rank test.
groups
  1. description
    Participants will receive: Busulfan test dose of 25 mg/m\^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m\^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m\^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC \> 1000/mL for 3 consecutive days.
    id
    OG000
    title
    Treatment
population Description
Due to study termination, data were not collected and the outcome measure was not analyzed.
reporting Status
POSTED
time Frame
2 years
title
Comparison of EFS Distribution to That of CALGB-100002
type
PRIMARY

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

Preserved source evidence · Not medical advice