TriangleNCT03289910 · OUTCOME
Number of Participants With a Response
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 7 months
What was measured
Based on published standards for acute leukemias, Complete Response (CR) means less than 5% leukemic blasts in the bone marrow, no blasts in the blood, no longer presence of cytogenetic abnormalities, no longer presence of extramedullary disease, with or without absolute neutrophil count or platelet count recovery; Partial Remission (PR) includes the criteria for Complete Remission except there are 5-25% leukemic blasts in the bone marrow and there is absolute neutrophil count and platelet count recovery; Hematologic Improvement (HI) means the disease has not gotten worse and there is at least a 20% decrease in the leukemic blasts in the bone marrow and/or a decrease in leukemia symptoms. Response = CR, PR, or HI.
Groups in this outcome
Arm A (Veliparib, Topotecan Hydrochloride, Carboplatin)
Patients receive veliparib PO BID on days 1-21 and topotecan hydrochloride IV continuously over 24 hours and carboplatin IV continuously over 24 hours on days 3-7. Treatment repeats every 28-63 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Arm B (Topotecan Hydrochloride, Carboplatin)
Patients receive topotecan hydrochloride IV continuously over 24 hours and carboplatin IV continuously over 24 hours on days 1-5. Treatment repeats every 28-63 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Arm A (Veliparib, Topotecan Hydrochloride, Carboplatin) | 16 |
| Arm B (Topotecan Hydrochloride, Carboplatin) | 9 |
Reported measurements
Source class 1
Participants with a response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Veliparib, Topotecan Hydrochloride, Carboplatin) | 5 | Not reported | Not reported | Not reported | Not reported |
| Arm B (Topotecan Hydrochloride, Carboplatin) | 4 | Not reported | Not reported | Not reported | Not reported |
Participants who did not have a response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Veliparib, Topotecan Hydrochloride, Carboplatin) | 11 | Not reported | Not reported | Not reported | Not reported |
| Arm B (Topotecan Hydrochloride, Carboplatin) | 5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 4
- title
- Participants with a response
- measurements
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 5
- title
- Participants who did not have a response
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 9
- units
- Participants
- description
- Based on published standards for acute leukemias, Complete Response (CR) means less than 5% leukemic blasts in the bone marrow, no blasts in the blood, no longer presence of cytogenetic abnormalities, no longer presence of extramedullary disease, with or without absolute neutrophil count or platelet count recovery; Partial Remission (PR) includes the criteria for Complete Remission except there are 5-25% leukemic blasts in the bone marrow and there is absolute neutrophil count and platelet count recovery; Hematologic Improvement (HI) means the disease has not gotten worse and there is at least a 20% decrease in the leukemic blasts in the bone marrow and/or a decrease in leukemia symptoms. Response = CR, PR, or HI.
- groups
- description
- Patients receive veliparib PO BID on days 1-21 and topotecan hydrochloride IV continuously over 24 hours and carboplatin IV continuously over 24 hours on days 3-7. Treatment repeats every 28-63 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Arm A (Veliparib, Topotecan Hydrochloride, Carboplatin)
- description
- Patients receive topotecan hydrochloride IV continuously over 24 hours and carboplatin IV continuously over 24 hours on days 1-5. Treatment repeats every 28-63 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- Arm B (Topotecan Hydrochloride, Carboplatin)
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Up to 7 months
- title
- Number of Participants With a Response
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice