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NCT03146871 · OUTCOME

Assessment of Toxicity to Hypomethylating Agent (HMA)

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
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 13 months (up to 12 cycles + 30 days) from the start of treatment.

What was measured

Toxicity will be assessed and graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0, after each cycle.

Analysis population: Safety analysis includes all participants who completed 2 cycles of treatment.

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

Neutropenia CTCAE Grade ≥3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (sEphB4-HSA, Azacitidine, Decitabine)2Not reportedNot reportedNot reportedNot reported
Febrile neutropenia CTCAE Grade ≥3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (sEphB4-HSA, Azacitidine, Decitabine)1Not reportedNot reportedNot reportedNot reported
Thrombocytopenia CTCAE Grade ≥3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (sEphB4-HSA, Azacitidine, Decitabine)3Not reportedNot reportedNot reportedNot reported
Leukopenia CTCAE Grade ≥3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (sEphB4-HSA, Azacitidine, Decitabine)3Not reportedNot reportedNot reportedNot reported
Hypertension CTCAE Grade ≥3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (sEphB4-HSA, Azacitidine, Decitabine)1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Neutropenia CTCAE Grade ≥3
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Febrile neutropenia CTCAE Grade ≥3
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Thrombocytopenia CTCAE Grade ≥3
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Leukopenia CTCAE Grade ≥3
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Hypertension CTCAE Grade ≥3
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    units
    Participants
description
Toxicity will be assessed and graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0, after each cycle.
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
NUMBER
population Description
Safety analysis includes all participants who completed 2 cycles of treatment.
reporting Status
POSTED
time Frame
Up to 13 months (up to 12 cycles + 30 days) from the start of treatment.
title
Assessment of Toxicity to Hypomethylating Agent (HMA)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice