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NCT01300572 · OUTCOME

The MTD of Radiation Delivered Via 90Y-DOTA-BC8 When Combined With FLU and 2 Gy TBI as a Preparative Regimen for Patients Aged ≥ 18 With Advanced AML, ALL, and High-risk MDS.

Yttrium-90 Anti-CD45 Monoclonal Antibody BC8 Followed by Donor Stem Cell Transplant in Treating Patients With High-Risk AML, ALL, or MDS · Source last updated 2019-12-10

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

Measure
NUMBER
Unit
Gy
Interval / dispersion
Not reported
Time frame
Within the first 30 days following transplant

What was measured

The MTD will be defined as the dose that is associated with a true DLT rate of 25%. The highest dose achieved was 28 Gy but none of the patients experienced a DLT. Thus, the MTD was not reached.

Analysis population: Study participants who completed the study regimen.

Groups in this outcome

Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)

Study participants will receive an infusion of 0.5 mg/kg of ideal body weight of DOTA-BC8 trace labeled with \~5-10 mCi of Indium-111 to evaluate biodistribution and calculate the radiation absorbed doses to major organs and the whole body. The subsequent therapy infusion of Yttrium-90-DOTA-BC8 will deliver an amount of Yttrium-90 calculated not to exceed the target dose to the critical normal organ receiving the highest radiation dose. The therapy dose will be administered on approximately day -12 of the preparative regimen, which will typically be approximately 1 to 2 weeks after the biodistribution 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
Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)15

Reported measurements

Source class 1
Values in Gy · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)28Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        28
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    units
    Participants
description
The MTD will be defined as the dose that is associated with a true DLT rate of 25%. The highest dose achieved was 28 Gy but none of the patients experienced a DLT. Thus, the MTD was not reached.
groups
  1. description
    Study participants will receive an infusion of 0.5 mg/kg of ideal body weight of DOTA-BC8 trace labeled with \~5-10 mCi of Indium-111 to evaluate biodistribution and calculate the radiation absorbed doses to major organs and the whole body. The subsequent therapy infusion of Yttrium-90-DOTA-BC8 will deliver an amount of Yttrium-90 calculated not to exceed the target dose to the critical normal organ receiving the highest radiation dose. The therapy dose will be administered on approximately day -12 of the preparative regimen, which will typically be approximately 1 to 2 weeks after the biodistribution dose.
    id
    OG000
    title
    Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)
param Type
NUMBER
population Description
Study participants who completed the study regimen.
reporting Status
POSTED
time Frame
Within the first 30 days following transplant
title
The MTD of Radiation Delivered Via 90Y-DOTA-BC8 When Combined With FLU and 2 Gy TBI as a Preparative Regimen for Patients Aged ≥ 18 With Advanced AML, ALL, and High-risk MDS.
type
PRIMARY
unit Of Measure
Gy

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

Preserved source evidence · Not medical advice