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NCT00843882 · OUTCOME

Association Between Major Erythroid Response and Cytogenetic Response

Lenalidomide With or Without Epoetin Alfa in Treating Patients With Myelodysplastic Syndrome and Anemia · Source last updated 2026-09-02

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
Assessed at baseline and after completion of 16 weeks of treatment

What was measured

Major erythroid response is defined as transfusion-independence for ≥ 8 consecutive weeks for patients who were red blood cell transfusion-dependent at baseline AND a ≥ 1 g/dL hemoglobin rise compared to mean pre-transfusion baseline value; or a \> 2 g/dL rise in hemoglobin without transfusion for non-transfusion dependent patients. Evaluation of cytogenetic response requires 20 analyzable metaphases before and after treatment, which must be done on bone marrow only. Fluorescent in situ hybridization (FISH) may be used as a supplement to follow a specifically defined cytogenetic abnormality, but it is not a substitute for conventional cytogenetic studies. Cytogenetic response is defined as follows: Complete response: Restoration of a normal karyotype in patients with a documented pre-existing clonal (\>2 metaphases abnormal) chromosome abnormalities. Partial response: \> 50% reduction in the percentage of bone marrow metaphases with only clonal abnormality.

Analysis population: Evaluable patients in both arms A and B who had both major erythroid response data and cytogenetic response data

Groups in this outcome

Major Erythroid Response

Patients with major erythroid response

No Major Erythroid Response

Patients without major erythroid response

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

Analysis denominator · Participants

GroupSource count
Major Erythroid Response23
No Major Erythroid Response83

Reported measurements

Source class 1

Cytogenetic response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Major Erythroid Response4Not reportedNot reportedNot reportedNot reported
No Major Erythroid Response5Not reportedNot reportedNot reportedNot reported

No cytogenetic response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Major Erythroid Response19Not reportedNot reportedNot reportedNot reported
No Major Erythroid Response78Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        5
      title
      Cytogenetic response
    2. measurements
      1. group Id
        OG000
        value
        19
      2. group Id
        OG001
        value
        78
      title
      No cytogenetic response
denoms
  1. counts
    1. group Id
      OG000
      value
      23
    2. group Id
      OG001
      value
      83
    units
    Participants
description
Major erythroid response is defined as transfusion-independence for ≥ 8 consecutive weeks for patients who were red blood cell transfusion-dependent at baseline AND a ≥ 1 g/dL hemoglobin rise compared to mean pre-transfusion baseline value; or a \> 2 g/dL rise in hemoglobin without transfusion for non-transfusion dependent patients. Evaluation of cytogenetic response requires 20 analyzable metaphases before and after treatment, which must be done on bone marrow only. Fluorescent in situ hybridization (FISH) may be used as a supplement to follow a specifically defined cytogenetic abnormality, but it is not a substitute for conventional cytogenetic studies. Cytogenetic response is defined as follows: Complete response: Restoration of a normal karyotype in patients with a documented pre-existing clonal (\>2 metaphases abnormal) chromosome abnormalities. Partial response: \> 50% reduction in the percentage of bone marrow metaphases with only clonal abnormality.
groups
  1. description
    Patients with major erythroid response
    id
    OG000
    title
    Major Erythroid Response
  2. description
    Patients without major erythroid response
    id
    OG001
    title
    No Major Erythroid Response
param Type
COUNT_OF_PARTICIPANTS
population Description
Evaluable patients in both arms A and B who had both major erythroid response data and cytogenetic response data
reporting Status
POSTED
time Frame
Assessed at baseline and after completion of 16 weeks of treatment
title
Association Between Major Erythroid Response and Cytogenetic Response
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice