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NCT01254890 · OUTCOME

Phase II: Number of Participants With Response

Sorafenib and 5-Azacitidine in Acute Leukemia + Myelodysplastic Syndrome · Source last updated 2016-05-06

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
90 days

What was measured

Response according to International Working Group response criteria for Acute myeloid leukemia (AML) (JCO 2003; 21: 4642-9): CR defined by presence of \<5% blasts in the bone marrow (BM), with \>1 X 10\^9/L neutrophils and \>100 x 10\^9/L platelets in the peripheral blood (PB) with no detectable extramedullary disease. Participants who met the above criteria but had neutrophil or platelet counts less than the stated values were considered to have achieved CRi (CR with incomplete recovery of PB counts) or CR with incomplete platelet recovery (CRp) if CR but platelets \< 100 x 10\^9/L but ≥ 50 x 10\^9/L and platelet transfusion independent. Partial response (PR) required all of the hematologic values for a CR but with a decrease of \>/= 50% in the percentage of blasts to 5% to 25% in the BM aspirate.

Analysis population: Nine participants were not evaluable for response.

Groups in this outcome

Azacitidine + Sorafenib

Azacitidine (AZA) 75 mg/m\^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib starting dose 200 mg orally twice a day for 28 Day cycle.

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

Analysis denominator · Participants

GroupSource count
Azacitidine + Sorafenib48

Reported measurements

Complete Response (CR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Azacitidine + Sorafenib8Not reportedNot reportedNot reportedNot reported
Complete Remission Without Platelet Recovery (CRi)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Azacitidine + Sorafenib10Not reportedNot reportedNot reportedNot reported
Partial Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Azacitidine + Sorafenib1Not reportedNot reportedNot reportedNot reported
Complete Response (CRp)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Azacitidine + Sorafenib6Not reportedNot reportedNot reportedNot reported
No Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Azacitidine + Sorafenib23Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    Complete Response (CR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        10
    title
    Complete Remission Without Platelet Recovery (CRi)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Partial Response
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Complete Response (CRp)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        23
    title
    No Response
denoms
  1. counts
    1. group Id
      OG000
      value
      48
    units
    Participants
description
Response according to International Working Group response criteria for Acute myeloid leukemia (AML) (JCO 2003; 21: 4642-9): CR defined by presence of \<5% blasts in the bone marrow (BM), with \>1 X 10\^9/L neutrophils and \>100 x 10\^9/L platelets in the peripheral blood (PB) with no detectable extramedullary disease. Participants who met the above criteria but had neutrophil or platelet counts less than the stated values were considered to have achieved CRi (CR with incomplete recovery of PB counts) or CR with incomplete platelet recovery (CRp) if CR but platelets \< 100 x 10\^9/L but ≥ 50 x 10\^9/L and platelet transfusion independent. Partial response (PR) required all of the hematologic values for a CR but with a decrease of \>/= 50% in the percentage of blasts to 5% to 25% in the BM aspirate.
groups
  1. description
    Azacitidine (AZA) 75 mg/m\^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib starting dose 200 mg orally twice a day for 28 Day cycle.
    id
    OG000
    title
    Azacitidine + Sorafenib
param Type
NUMBER
population Description
Nine participants were not evaluable for response.
reporting Status
POSTED
time Frame
90 days
title
Phase II: Number of Participants With Response
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice