TriangleNCT05184842 · OUTCOME
Overall Response Rate in Patients With HR-MDS
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
- At the time of censoring of data, up to ~21 months
What was measured
ORR was determined in patients with HR-MDS. ORR was defined by summarizing and calculating the number/percentage of patients with Complete Remission + marrow Complete Remission (CR + mCR) based on International Working Group (IWG) criteria. Based on IWG criteria CR and mCR are considered the best outcomes and used for this endpoint. CR is defined as Bone marrow (BM): ≤ 5% myeloblasts with normal maturation of all cell lines, dysplasia may persist. Peripheral Blood (PB): Hgb ≥ 11g/dL, Platelets ≥ 100 x 10\^9/L, Neutrophils ≥ 1.0 x 10\^9/L, Blasts 0%. mCR is defined as BM: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment. PB: if Hematologic Improvement (HI) responses, should be noted in addition to mCR (in this study, mCR absent HI is NOT considered a response). All responses must last ≥ 4 weeks. Patients who have any response will be permitted to continue treatment until relapse or progression of disease. Results are summarized using basic descriptive statistics.
Analysis population: 6 patients who comprised the Primary Outcome analysis were part of the HR-MDS cohort.
Groups in this outcome
Decitabine/Venetoclax (Single Arm)
Administration: Decitabine is reconstituted with 5 ml sterile water to facilitate subcutaneous administration. Decitabine is given by subcutaneous injection. Venetoclax is taken as a tablet prepared by patients pharmacy. Venetoclax is given at a dose of 400 mg po once per week concurrently with the Decitabine dose (+/- 1 day allowed ). Venetoclax: Venetoclax 400 mg po on days 1, 8, 15 and 22 of each cycle (28-day cycle) Decitabine: Decitabine 0.2 mg/kg SQ (subcutaneous) on days 2, 9, 16, 23 (for aggressive disease will add decitabine on days 3, 10, 17, 24)
| Group | Source count |
|---|---|
| Decitabine/Venetoclax (Single Arm) | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Decitabine/Venetoclax (Single Arm) | 4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 4
- denoms
- counts
- group Id
- OG000
- value
- 6
- units
- Participants
- description
- ORR was determined in patients with HR-MDS. ORR was defined by summarizing and calculating the number/percentage of patients with Complete Remission + marrow Complete Remission (CR + mCR) based on International Working Group (IWG) criteria. Based on IWG criteria CR and mCR are considered the best outcomes and used for this endpoint. CR is defined as Bone marrow (BM): ≤ 5% myeloblasts with normal maturation of all cell lines, dysplasia may persist. Peripheral Blood (PB): Hgb ≥ 11g/dL, Platelets ≥ 100 x 10\^9/L, Neutrophils ≥ 1.0 x 10\^9/L, Blasts 0%. mCR is defined as BM: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment. PB: if Hematologic Improvement (HI) responses, should be noted in addition to mCR (in this study, mCR absent HI is NOT considered a response). All responses must last ≥ 4 weeks. Patients who have any response will be permitted to continue treatment until relapse or progression of disease. Results are summarized using basic descriptive statistics.
- groups
- description
- Administration: Decitabine is reconstituted with 5 ml sterile water to facilitate subcutaneous administration. Decitabine is given by subcutaneous injection. Venetoclax is taken as a tablet prepared by patients pharmacy. Venetoclax is given at a dose of 400 mg po once per week concurrently with the Decitabine dose (+/- 1 day allowed ). Venetoclax: Venetoclax 400 mg po on days 1, 8, 15 and 22 of each cycle (28-day cycle) Decitabine: Decitabine 0.2 mg/kg SQ (subcutaneous) on days 2, 9, 16, 23 (for aggressive disease will add decitabine on days 3, 10, 17, 24)
- id
- OG000
- title
- Decitabine/Venetoclax (Single Arm)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- 6 patients who comprised the Primary Outcome analysis were part of the HR-MDS cohort.
- reporting Status
- POSTED
- time Frame
- At the time of censoring of data, up to ~21 months
- title
- Overall Response Rate in Patients With HR-MDS
- type
- POST_HOC
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice