TriangleNCT03146871 · OUTCOME
Overall Response Defined as the Occurrence of Complete Response, Marrow Complete Response, Partial Response, or Hematological Improvement
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 56 days (2 courses of protocol treatment)
What was measured
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.
Analysis population: Participants who completed at least 2 cycles were assessed for response.
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 | Source count |
|---|---|
| Treatment (sEphB4-HSA, Azacitidine, Decitabine) | 7 |
Reported measurements
Complete Remission
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (sEphB4-HSA, Azacitidine, Decitabine) | 0 | Not reported | Not reported | Not reported | Not reported |
Marrow Complete Remission
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (sEphB4-HSA, Azacitidine, Decitabine) | 0 | Not reported | Not reported | Not reported | Not reported |
Partial Remission
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (sEphB4-HSA, Azacitidine, Decitabine) | 0 | Not reported | Not reported | Not reported | Not reported |
Hematological Improvement
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (sEphB4-HSA, Azacitidine, Decitabine) | 1 | Not reported | Not reported | Not reported | Not reported |
Stable Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (sEphB4-HSA, Azacitidine, Decitabine) | 2 | Not reported | Not reported | Not reported | Not reported |
Failure
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (sEphB4-HSA, Azacitidine, Decitabine) | 4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- title
- Complete Remission
- categories
- measurements
- group Id
- OG000
- value
- 0
- title
- Marrow Complete Remission
- categories
- measurements
- group Id
- OG000
- value
- 0
- title
- Partial Remission
- categories
- measurements
- group Id
- OG000
- value
- 1
- title
- Hematological Improvement
- categories
- measurements
- group Id
- OG000
- value
- 2
- title
- Stable Disease
- categories
- measurements
- group Id
- OG000
- value
- 4
- title
- Failure
- denoms
- counts
- group Id
- OG000
- value
- 7
- units
- Participants
- description
- 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.
- groups
- 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
- Participants who completed at least 2 cycles were assessed for response.
- reporting Status
- POSTED
- time Frame
- Up to 56 days (2 courses of protocol treatment)
- title
- Overall Response Defined as the Occurrence of Complete Response, Marrow Complete Response, Partial Response, or Hematological Improvement
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice