TriangleNCT00112723 · OUTCOME
Complete and Partial Response Rate (Phase II)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- patients
- Interval / dispersion
- Not reported
- Time frame
- Up to 2 years
What was measured
Patients were assessed for clinical response after two , four and six cycle with laboratory studies, physical exam, and CT scans. Response was evaluated using the modified NCI-sponsored Working Group Lymphoma Response Criteria.
Analysis population: Includes patients enrolled with Indolent B-cell NHL, Intermediate Grade B NHL, Mantle cell NHL and T/NK-cell NHL
Groups in this outcome
Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2)
Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2)
Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Dose Level 3 Dose (Flavopiridol 50 mg/m2 + 50 mg/m2)
Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
| Group | Source count |
|---|---|
| Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2) | 12 |
| Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2) | 17 |
| Dose Level 3 Dose (Flavopiridol 50 mg/m2 + 50 mg/m2) | 14 |
Reported measurements
Complete Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 3 Dose (Flavopiridol 50 mg/m2 + 50 mg/m2) | 0 | Not reported | Not reported | Not reported | Not reported |
Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2) | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2) | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 3 Dose (Flavopiridol 50 mg/m2 + 50 mg/m2) | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Complete Response
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- title
- Partial Response
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 17
- group Id
- OG002
- value
- 14
- units
- Participants
- description
- Patients were assessed for clinical response after two , four and six cycle with laboratory studies, physical exam, and CT scans. Response was evaluated using the modified NCI-sponsored Working Group Lymphoma Response Criteria.
- groups
- description
- Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
- id
- OG000
- title
- Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2)
- description
- Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
- id
- OG001
- title
- Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2)
- description
- Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
- id
- OG002
- title
- Dose Level 3 Dose (Flavopiridol 50 mg/m2 + 50 mg/m2)
- param Type
- NUMBER
- population Description
- Includes patients enrolled with Indolent B-cell NHL, Intermediate Grade B NHL, Mantle cell NHL and T/NK-cell NHL
- reporting Status
- POSTED
- time Frame
- Up to 2 years
- title
- Complete and Partial Response Rate (Phase II)
- type
- PRIMARY
- unit Of Measure
- patients
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice