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NCT00924040 · OUTCOME

Percentage of Patients Who Respond Clinically, Who Also Have Normalization in sCD22 or sCD25

Retreatment Protocol for BL22 Immunotherapy in Relapsed or Refractory Hairy Cell Leukemia · Source last updated 2015-10-29

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

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
Not reported
Time frame
patients may undergo lymphapheresis before the first and/or later cycles up to 12 months after achieving CR or PR

What was measured

CD25 (sCD25)and CD22 (sCD22) quantify hairy cell leukemia (HCL) tumor burden. Patients with either PR or CR are evaluated for soluble forms of CD25 (sCD25) and soluble CD22 (sCD22). The number of patients with PR or CR who have normalization of sCD25 and sCD22 will be recorded. Normalization is considered \<3 ng/ml for sCD25, and \<2 ng/ml for sCD22. Patients will be assessed for normalization of sCD25 and sCD22 for at least 12 months after achieving PR or CR.

Groups in this outcome

BL22 Immunotherapy

30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.

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

Analysis denominator · Participants

GroupSource count
BL22 Immunotherapy1

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
BL22 Immunotherapy100Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        100
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    units
    Participants
description
CD25 (sCD25)and CD22 (sCD22) quantify hairy cell leukemia (HCL) tumor burden. Patients with either PR or CR are evaluated for soluble forms of CD25 (sCD25) and soluble CD22 (sCD22). The number of patients with PR or CR who have normalization of sCD25 and sCD22 will be recorded. Normalization is considered \<3 ng/ml for sCD25, and \<2 ng/ml for sCD22. Patients will be assessed for normalization of sCD25 and sCD22 for at least 12 months after achieving PR or CR.
groups
  1. description
    30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
    id
    OG000
    title
    BL22 Immunotherapy
param Type
NUMBER
reporting Status
POSTED
time Frame
patients may undergo lymphapheresis before the first and/or later cycles up to 12 months after achieving CR or PR
title
Percentage of Patients Who Respond Clinically, Who Also Have Normalization in sCD22 or sCD25
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice