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NCT01101880 · OUTCOME

Rates of Complete Remission and Complete Remission With Incomplete Recovery of Counts

Clofarabine, Cytarabine, and Filgrastim in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia, Advanced Myelodysplastic Syndrome, and/or Advanced Myeloproliferative Neoplasm · Source last updated 2017-10-19

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 5 years

What was measured

With 50 patients, the rates of these endpoints will be estimated with a standard error of 5 to 7 percentage points, depending on the observed rates. Complete remission is defined as less than 5% blast cells present in the bone marrow and count recovery (absolute neutrophil count greater than 1000/microL and platelet count greater than 100,000/microL). Complete remission with incomplete recovery of counts is defined as less than 5% blast cells present in the bone marrow without compete count recovery (absolute neutrophil count less than 1000/microL and platelet count less than 100,000/microL).

Analysis population: CR achieved with no AHD only applies to those who did not have AHD.

Groups in this outcome

Treatment (Chemotherapy and Colony Stimulating Factor)

INDUCTION THERAPY: Patients receive filgrastim SC daily beginning the day prior to chemotherapy and continuing until blood counts recover. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 5 days. CONSOLIDATION THERAPY: Patients receive filgrastim SC daily for 5 days beginning the day prior to chemotherapy. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 4 days. Treatment with induction therapy may continue for up to 2 courses and treatment with consolidation therapy may continue for up to 3 courses in the absence of disease progression or unacceptable toxicity. filgrastim: Given SC clofarabine: Given IV cytarabine: Given IV

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 (Chemotherapy and Colony Stimulating Factor)50

Reported measurements

CR achieved

Analysis denominator · Participants

GroupSource count
Treatment (Chemotherapy and Colony Stimulating Factor)50
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Chemotherapy and Colony Stimulating Factor)38Not reportedNot reportedNot reportedNot reported
CR achieved with first course of induction

Analysis denominator · Participants

GroupSource count
Treatment (Chemotherapy and Colony Stimulating Factor)50
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Chemotherapy and Colony Stimulating Factor)33Not reportedNot reportedNot reportedNot reported
CR + CRp achieved

Analysis denominator · Participants

GroupSource count
Treatment (Chemotherapy and Colony Stimulating Factor)50
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Chemotherapy and Colony Stimulating Factor)41Not reportedNot reportedNot reportedNot reported
CR achieved with no AHD

Analysis denominator · Participants

GroupSource count
Treatment (Chemotherapy and Colony Stimulating Factor)27
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Chemotherapy and Colony Stimulating Factor)23Not reportedNot reportedNot reportedNot reported
CR achieved with AHD

Analysis denominator · Participants

GroupSource count
Treatment (Chemotherapy and Colony Stimulating Factor)23
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Chemotherapy and Colony Stimulating Factor)15Not reportedNot reportedNot reportedNot reported
CR + CRp achieved with AHD

Analysis denominator · Participants

GroupSource count
Treatment (Chemotherapy and Colony Stimulating Factor)23
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Chemotherapy and Colony Stimulating Factor)18Not reportedNot reportedNot reportedNot reported
CR achieved with FLT3 positive

Analysis denominator · Participants

GroupSource count
Treatment (Chemotherapy and Colony Stimulating Factor)10
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Chemotherapy and Colony Stimulating Factor)7Not reportedNot reportedNot reportedNot reported
CR achieved with favorable risk cytogenetics

Analysis denominator · Participants

GroupSource count
Treatment (Chemotherapy and Colony Stimulating Factor)4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Chemotherapy and Colony Stimulating Factor)4Not reportedNot reportedNot reportedNot reported
CR achieved with intermediate risk cytogenetics

Analysis denominator · Participants

GroupSource count
Treatment (Chemotherapy and Colony Stimulating Factor)32
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Chemotherapy and Colony Stimulating Factor)26Not reportedNot reportedNot reportedNot reported
CR + CRp achieved with intermediate risk cyto.

Analysis denominator · Participants

GroupSource count
Treatment (Chemotherapy and Colony Stimulating Factor)32
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Chemotherapy and Colony Stimulating Factor)27Not reportedNot reportedNot reportedNot reported
CR achieved with unfavorable risk cytogenetics

Analysis denominator · Participants

GroupSource count
Treatment (Chemotherapy and Colony Stimulating Factor)13
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Chemotherapy and Colony Stimulating Factor)8Not reportedNot reportedNot reportedNot reported
CR + CRp achieved with unfavorable risk cyto.

Analysis denominator · Participants

GroupSource count
Treatment (Chemotherapy and Colony Stimulating Factor)13
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Chemotherapy and Colony Stimulating Factor)10Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        38
    denoms
    1. counts
      1. group Id
        OG000
        value
        50
      units
      Participants
    title
    CR achieved
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        33
    denoms
    1. counts
      1. group Id
        OG000
        value
        50
      units
      Participants
    title
    CR achieved with first course of induction
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        41
    denoms
    1. counts
      1. group Id
        OG000
        value
        50
      units
      Participants
    title
    CR + CRp achieved
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        23
    denoms
    1. counts
      1. group Id
        OG000
        value
        27
      units
      Participants
    title
    CR achieved with no AHD
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        15
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      units
      Participants
    title
    CR achieved with AHD
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        18
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      units
      Participants
    title
    CR + CRp achieved with AHD
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        7
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      units
      Participants
    title
    CR achieved with FLT3 positive
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    CR achieved with favorable risk cytogenetics
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        26
    denoms
    1. counts
      1. group Id
        OG000
        value
        32
      units
      Participants
    title
    CR achieved with intermediate risk cytogenetics
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        27
    denoms
    1. counts
      1. group Id
        OG000
        value
        32
      units
      Participants
    title
    CR + CRp achieved with intermediate risk cyto.
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      units
      Participants
    title
    CR achieved with unfavorable risk cytogenetics
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        10
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      units
      Participants
    title
    CR + CRp achieved with unfavorable risk cyto.
denoms
  1. counts
    1. group Id
      OG000
      value
      50
    units
    Participants
description
With 50 patients, the rates of these endpoints will be estimated with a standard error of 5 to 7 percentage points, depending on the observed rates. Complete remission is defined as less than 5% blast cells present in the bone marrow and count recovery (absolute neutrophil count greater than 1000/microL and platelet count greater than 100,000/microL). Complete remission with incomplete recovery of counts is defined as less than 5% blast cells present in the bone marrow without compete count recovery (absolute neutrophil count less than 1000/microL and platelet count less than 100,000/microL).
groups
  1. description
    INDUCTION THERAPY: Patients receive filgrastim SC daily beginning the day prior to chemotherapy and continuing until blood counts recover. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 5 days. CONSOLIDATION THERAPY: Patients receive filgrastim SC daily for 5 days beginning the day prior to chemotherapy. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 4 days. Treatment with induction therapy may continue for up to 2 courses and treatment with consolidation therapy may continue for up to 3 courses in the absence of disease progression or unacceptable toxicity. filgrastim: Given SC clofarabine: Given IV cytarabine: Given IV
    id
    OG000
    title
    Treatment (Chemotherapy and Colony Stimulating Factor)
param Type
COUNT_OF_PARTICIPANTS
population Description
CR achieved with no AHD only applies to those who did not have AHD.
reporting Status
POSTED
time Frame
Up to 5 years
title
Rates of Complete Remission and Complete Remission With Incomplete Recovery of Counts
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice