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NCT01711632 · OUTCOME

To Assess the Pharmacodynamics Change From Baseline

BRAF Inhibitor, Vemurafenib, in Patients With Relapsed or Refractory Hairy Cell Leukemia · Source last updated 2025-10-20

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
2 years

What was measured

Peripheral blood and/or bone marrow aspirate samples from pretreatment and post-treatment at specified time points will be assessed by Western Blot or by phospho-flow for the downstream targets of BRAF (MEK, pMEK, ERK, pERK) to assess the ontarget effect of the Vemurafenib. The droplet digital PCR assay was performed to quantify the concentration of molecules with mutated BRAF V600E DNA at baseline and again at 12 weeks of vermurafenib therapy.

Groups in this outcome

Vemurafenib

Eligible patients will receive vemurafenib at a dose of 960mg orally twice daily (b.i.d.) continuously in cycles of 4 weeks (28 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
Vemurafenib36

Reported measurements

Pts with a decrease of the concentration of molecules with mutated BRAF V600E DNA at 12 wks
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Vemurafenib24Not reportedNot reportedNot reportedNot reported
Pts without decrease of the concentration of molecules with mutated BRAF V600E DNA at 12 wks
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Vemurafenib12Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        24
    title
    Pts with a decrease of the concentration of molecules with mutated BRAF V600E DNA at 12 wks
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        12
    title
    Pts without decrease of the concentration of molecules with mutated BRAF V600E DNA at 12 wks
denoms
  1. counts
    1. group Id
      OG000
      value
      36
    units
    Participants
description
Peripheral blood and/or bone marrow aspirate samples from pretreatment and post-treatment at specified time points will be assessed by Western Blot or by phospho-flow for the downstream targets of BRAF (MEK, pMEK, ERK, pERK) to assess the ontarget effect of the Vemurafenib. The droplet digital PCR assay was performed to quantify the concentration of molecules with mutated BRAF V600E DNA at baseline and again at 12 weeks of vermurafenib therapy.
groups
  1. description
    Eligible patients will receive vemurafenib at a dose of 960mg orally twice daily (b.i.d.) continuously in cycles of 4 weeks (28 days).
    id
    OG000
    title
    Vemurafenib
param Type
NUMBER
reporting Status
POSTED
time Frame
2 years
title
To Assess the Pharmacodynamics Change From Baseline
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice