Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00924040 · OUTCOME

Number of Months to Response to Treatment

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
Months
Interval / dispersion
Not reported
Time frame
2/14/2009 till 6/24/2010

What was measured

Response is defined by the Response Evaluation Criteria in the protocol, namely the earliest point where all relevant tests (i.e. lab tests, physical exam, radiology results) are consistent with complete response (CR) or partial response (PR). CR or PR must be confirmed for at least 4 weeks. Complete response: No evidence of leukemic cells by routine H/E stains of the peripheral blood and bone marrow. Partial response:neutrophils \>/= 1,500/micrograms/L or 50% improvement over baseline without growth factors for at least 4 weeks.

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 Months · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
BL22 Immunotherapy2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    units
    Participants
description
Response is defined by the Response Evaluation Criteria in the protocol, namely the earliest point where all relevant tests (i.e. lab tests, physical exam, radiology results) are consistent with complete response (CR) or partial response (PR). CR or PR must be confirmed for at least 4 weeks. Complete response: No evidence of leukemic cells by routine H/E stains of the peripheral blood and bone marrow. Partial response:neutrophils \>/= 1,500/micrograms/L or 50% improvement over baseline without growth factors for at least 4 weeks.
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
2/14/2009 till 6/24/2010
title
Number of Months to Response to Treatment
type
PRIMARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice