Trial Outcomes & Findings for 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 (NCT NCT03146871)
NCT ID: NCT03146871
Last Updated: 2026-06-08
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
Up to 13 months (up to 12 cycles + 30 days) from the start of treatment.
Results posted on
2026-06-08
Participant Flow
Recruitment for this study started in April 2017 and ended in March 2019 due to lack of funding. All participants were seen and treated at University of Southern California Norris Comprehensive Cancer Center and/or Los Angeles County+University of Southern California Medical Center.
The study has no pre-assignment. All participants were given the same treatment.
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Treatment (sEphB4-HSA, Azacitidine, Decitabine)
n=7 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=9 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Up to 13 months (up to 12 cycles + 30 days) from the start of treatment.Population: Safety analysis includes all participants who completed 2 cycles of treatment.
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.
Outcome measures
| Measure |
Treatment (sEphB4-HSA, Azacitidine, Decitabine)
n=7 Participants
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
|
|---|---|
|
Assessment of Toxicity to Hypomethylating Agent (HMA)
Neutropenia CTCAE Grade ≥3
|
2 Participants
|
|
Assessment of Toxicity to Hypomethylating Agent (HMA)
Febrile neutropenia CTCAE Grade ≥3
|
1 Participants
|
|
Assessment of Toxicity to Hypomethylating Agent (HMA)
Thrombocytopenia CTCAE Grade ≥3
|
3 Participants
|
|
Assessment of Toxicity to Hypomethylating Agent (HMA)
Leukopenia CTCAE Grade ≥3
|
3 Participants
|
|
Assessment of Toxicity to Hypomethylating Agent (HMA)
Hypertension CTCAE Grade ≥3
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 56 days (2 courses of protocol treatment)Population: Participants who completed at least 2 cycles were assessed for response.
Responses assessed by the International Working Group (IWG) 2023 criteria are a set of standardized guidelines used to assess treatment response in patients with myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). These criteria are designed to evaluate a patient's response based on hematologic improvements, such as changes in blood counts and transfusion independence.
Outcome measures
| Measure |
Treatment (sEphB4-HSA, Azacitidine, Decitabine)
n=7 Participants
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
|
|---|---|
|
Overall Response Defined as the Occurrence of Complete Response, Marrow Complete Response, Partial Response, or Hematological Improvement
Complete Remission
|
0 Participants
|
|
Overall Response Defined as the Occurrence of Complete Response, Marrow Complete Response, Partial Response, or Hematological Improvement
Marrow Complete Remission
|
0 Participants
|
|
Overall Response Defined as the Occurrence of Complete Response, Marrow Complete Response, Partial Response, or Hematological Improvement
Partial Remission
|
0 Participants
|
|
Overall Response Defined as the Occurrence of Complete Response, Marrow Complete Response, Partial Response, or Hematological Improvement
Hematological Improvement
|
1 Participants
|
|
Overall Response Defined as the Occurrence of Complete Response, Marrow Complete Response, Partial Response, or Hematological Improvement
Stable Disease
|
2 Participants
|
|
Overall Response Defined as the Occurrence of Complete Response, Marrow Complete Response, Partial Response, or Hematological Improvement
Failure
|
4 Participants
|
PRIMARY outcome
Timeframe: up to 1 year (12 cycles)Will be displayed with Kaplan-Meier plots.
Outcome measures
| Measure |
Treatment (sEphB4-HSA, Azacitidine, Decitabine)
n=7 Participants
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
|
|---|---|
|
Time to Death From Any Cause
|
4.1 Months
Interval 2.9 to 22.0
|
PRIMARY outcome
Timeframe: up to 1 year (12 cycles)This will be measured from the start of treatment to the first disease progression or recurrence. Patients who are progression free at the time of last follow-up will be censored; death prior to progression will be counted as an event.
Outcome measures
| Measure |
Treatment (sEphB4-HSA, Azacitidine, Decitabine)
n=7 Participants
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
|
|---|---|
|
Time to Disease Progression
|
3.1 Months
Interval 2.9 to 22.0
|
PRIMARY outcome
Timeframe: Up to 3 monthsPopulation: 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
Will be tabulated and reported according to grade, type, cycle, and attribution.
Outcome measures
| Measure |
Treatment (sEphB4-HSA, Azacitidine, Decitabine)
n=7 Participants
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
|
|---|---|
|
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
|
7 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At Baseline, then up to 3 years.Population: Not performed, study terminated early.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At Baseline, then up to 2 years.Population: Not performed, study terminated early.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (sEphB4-HSA, Azacitidine, Decitabine)
Serious events: 7 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment (sEphB4-HSA, Azacitidine, Decitabine)
n=7 participants at risk
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
|
|---|---|
|
Investigations
Neutrophil count decreased
|
28.6%
2/7 • Number of events 2 • Up to 13 months (up to 12 cycles + 30 days) from the start of treatment.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
14.3%
1/7 • Number of events 1 • Up to 13 months (up to 12 cycles + 30 days) from the start of treatment.
|
|
Investigations
Platelet count decreased
|
42.9%
3/7 • Number of events 3 • Up to 13 months (up to 12 cycles + 30 days) from the start of treatment.
|
|
Investigations
White blood cell decreased
|
42.9%
3/7 • Number of events 4 • Up to 13 months (up to 12 cycles + 30 days) from the start of treatment.
|
|
Vascular disorders
Hypertension
|
14.3%
1/7 • Number of events 1 • Up to 13 months (up to 12 cycles + 30 days) from the start of treatment.
|
Other adverse events
Adverse event data not reported
Additional Information
Victoria Soto, Clinical Research Regulatory Administrator
USC Norris Comprehensive Cancer Center
Phone: (323) 865-0454
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place