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NCT00544466 · OUTCOME

Number of Grade 3 and Above Toxicities of Helical Tomotherapy (HT) in Combination With Fludarabine and Melphalan Followed by Allogeneic Stem Cell Transplantation.

Helical Tomotherapy, Fludarabine Phosphate, and Melphalan Followed By Allo-HSCT in Hematological Malignancies · Source last updated 2026-02-19

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

Measure
NUMBER
Unit
events
Interval / dispersion
Not reported
Time frame
100 days post treatment

What was measured

Toxicities (adverse events) were evaluated using the modified Bearman Scale and the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

Groups in this outcome

Treatment (Enzyme Inhibitor, Radiation Therapy, Transplant)

PREPARATIVE REGIMEN\*: Patients receive fludarabine phosphate IV on days -7 to -3 and melphalan IV on day -2. Patients also undergo helical tomotherapy twice daily on days -7 to -4. TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0. NOTE: \*Treatment begins 2 days earlier in patients receive tacrolimus and/or sirolimus for GVHD prophylaxis. fludarabine phosphate: 25 mg/m2 day -7 through day -3 prior to transplant melphalan: 140 mg/m2 day -2 prior to transplant allogeneic hematopoietic stem cell transplantation: Cells infused on Day 0 of transplant regimen intensity-modulated radiation therapy: Each fraction is 150 cGy, 2 fractions each day on day -7 through day -4 prior to transplant

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

Analysis denominator · Participants

GroupSource count
Treatment (Enzyme Inhibitor, Radiation Therapy, Transplant)62

Reported measurements

Source class 1
Values in events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Enzyme Inhibitor, Radiation Therapy, Transplant)793Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        793
denoms
  1. counts
    1. group Id
      OG000
      value
      62
    units
    Participants
description
Toxicities (adverse events) were evaluated using the modified Bearman Scale and the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
groups
  1. description
    PREPARATIVE REGIMEN\*: Patients receive fludarabine phosphate IV on days -7 to -3 and melphalan IV on day -2. Patients also undergo helical tomotherapy twice daily on days -7 to -4. TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0. NOTE: \*Treatment begins 2 days earlier in patients receive tacrolimus and/or sirolimus for GVHD prophylaxis. fludarabine phosphate: 25 mg/m2 day -7 through day -3 prior to transplant melphalan: 140 mg/m2 day -2 prior to transplant allogeneic hematopoietic stem cell transplantation: Cells infused on Day 0 of transplant regimen intensity-modulated radiation therapy: Each fraction is 150 cGy, 2 fractions each day on day -7 through day -4 prior to transplant
    id
    OG000
    title
    Treatment (Enzyme Inhibitor, Radiation Therapy, Transplant)
param Type
NUMBER
reporting Status
POSTED
time Frame
100 days post treatment
title
Number of Grade 3 and Above Toxicities of Helical Tomotherapy (HT) in Combination With Fludarabine and Melphalan Followed by Allogeneic Stem Cell Transplantation.
type
PRIMARY
unit Of Measure
events

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

Preserved source evidence · Not medical advice