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NCT03146871 · OUTCOME

Tolerability Defined as the Ability to Complete Two Courses of Treatment Without the Occurrence of Dose Limiting Toxicity and the Ability to Begin Course 3 Within 4 Weeks and Graded According to the NCI CTCAE v4.0

Recombinant EphB4-HSA Fusion Protein and Azacitidine or Decitabine for Relapsed or Refractory Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia Patients Previously Treated With a Hypomethylating Agent · Source last updated 2026-06-08

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

What was measured

Will be tabulated and reported according to grade, type, cycle, and attribution.

Analysis population: Tolerability was assessed by summarizing the number of participants who completed two courses of treatment without the occurrence of dose limiting toxicity and the ability to begin course 3 within 4 weeks

Groups in this outcome

Treatment (sEphB4-HSA, Azacitidine, Decitabine)

Patients receive recombinant EphB4-HSA fusion protein intravenously (IV) over 60 minutes on days 1 and 15. Patients also receive azacitidine IV or subcutaneously (SC) on days 1-7 or days 1-5 and 8-9, or decitabine IV on days 1-5. Administration of recombinant EphB4-HSA fusion protein occurs before or after the HMA (not concurrently). Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Azacitidine: Given IV or SC Decitabine: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Recombinant EphB4-HSA Fusion Protein: 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 (sEphB4-HSA, Azacitidine, Decitabine)7

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (sEphB4-HSA, Azacitidine, Decitabine)7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        7
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    units
    Participants
description
Will be tabulated and reported according to grade, type, cycle, and attribution.
groups
  1. description
    Patients receive recombinant EphB4-HSA fusion protein intravenously (IV) over 60 minutes on days 1 and 15. Patients also receive azacitidine IV or subcutaneously (SC) on days 1-7 or days 1-5 and 8-9, or decitabine IV on days 1-5. Administration of recombinant EphB4-HSA fusion protein occurs before or after the HMA (not concurrently). Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Azacitidine: Given IV or SC Decitabine: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Recombinant EphB4-HSA Fusion Protein: Given IV
    id
    OG000
    title
    Treatment (sEphB4-HSA, Azacitidine, Decitabine)
param Type
COUNT_OF_PARTICIPANTS
population Description
Tolerability was assessed by summarizing the number of participants who completed two courses of treatment without the occurrence of dose limiting toxicity and the ability to begin course 3 within 4 weeks
reporting Status
POSTED
time Frame
Up to 3 months
title
Tolerability Defined as the Ability to Complete Two Courses of Treatment Without the Occurrence of Dose Limiting Toxicity and the Ability to Begin Course 3 Within 4 Weeks and Graded According to the NCI CTCAE v4.0
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice