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NCT01664897 · OUTCOME

Participants With a Response

Erlotinib Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia · Source last updated 2020-01-07

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 3 months post-treatment

What was measured

Overall Response is complete remission (CR) + CR with incomplete hematologic recovery (CRi) + Partial remission (PR) + Hematologic improvement (HI) + Morphologic Leukemia-Free State (MLF). (CR) is Bone marrow; \</=5% blasts, no Auer rods or extramedullary disease and peripheral blood counts \>/= 1.0x10\^9/L Neutrophils, \>/= 100x10\^9/L platelets and no circulating blasts. (CRi), same as CR for bone marrow and \<1.0x10\^9/L neutrophils and \< 100x10\^9/L platelets in peripheral blood counts. PR is all CR criteria if abnormal prior to treatment except \>/= 50%reduction in bone marrow blast but still \> 5%. MLF is \</=5% myeloblasts on bone marrow . HI response must be described by the number of positively affected cell lines..

Groups in this outcome

Treatment (Erlotinib Hydrochloride)

Patients receive erlotinib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Erlotinib Hydrochloride: Given PO Laboratory Biomarker Analysis: Correlative studies

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 (Erlotinib Hydrochloride)29

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Erlotinib Hydrochloride)3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
denoms
  1. counts
    1. group Id
      OG000
      value
      29
    units
    Participants
description
Overall Response is complete remission (CR) + CR with incomplete hematologic recovery (CRi) + Partial remission (PR) + Hematologic improvement (HI) + Morphologic Leukemia-Free State (MLF). (CR) is Bone marrow; \</=5% blasts, no Auer rods or extramedullary disease and peripheral blood counts \>/= 1.0x10\^9/L Neutrophils, \>/= 100x10\^9/L platelets and no circulating blasts. (CRi), same as CR for bone marrow and \<1.0x10\^9/L neutrophils and \< 100x10\^9/L platelets in peripheral blood counts. PR is all CR criteria if abnormal prior to treatment except \>/= 50%reduction in bone marrow blast but still \> 5%. MLF is \</=5% myeloblasts on bone marrow . HI response must be described by the number of positively affected cell lines..
groups
  1. description
    Patients receive erlotinib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Erlotinib Hydrochloride: Given PO Laboratory Biomarker Analysis: Correlative studies
    id
    OG000
    title
    Treatment (Erlotinib Hydrochloride)
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Up to 3 months post-treatment
title
Participants With a Response
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice