TriangleNCT04447027 · OUTCOME
Duration of Response (DOR) in Months Reported Along With a 95% Confidence Interval
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- up to a median of 11.7 months
What was measured
DOR will be determined and reported along with a 95% confidence interval. DOR is measured from the time measurement criteria are met for complete response (CR) or partial response (PR (whichever is recorded first) until the first date that recurrent or progressive disease is objectively documented. Response was measured by the Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria. Complete response (CR) is disappearance of all target lesions and all nodes with long axis \<10mm. Partial response (PR) is a ≥30% decrease in the sum of longest diameters of target lesions but not a CR. Progressive disease is \>20% increase in the sum of longest diameters of target lesions.
Groups in this outcome
Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide
T-cell Malignancies, Dose Escalation, Arm 1, Dose Level -1 Arm 1, Dose Level-1: Lenalidomide 2.5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 200 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide
T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 1 Arm 1, Dose Level 1: Lenalidomide 5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide
T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 2 Arm 1, Dose Level 2: Lenalidomide 10 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
Arm 1, Cohort 1, Dose Level 3 Dose Escalation
T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 3 Arm 1, Dose Level 3: Lenalidomide 15 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide
T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 4 Arm 1, Dose Level 4: Lenalidomide 20 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide
T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 2 Arm 2, Dose Level 2: Lenalidomide by oral intake at maximum tolerated dose (MTD) on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.
Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide
T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 4 Arm 2, Dose Level 4: Lenalidomide by oral intake at maximum tolerated dose (MTD) Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.
Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide
T-cell Malignancies, Dose Expansion, Arm 3, Dose Level 4 Arm 3, Dose Level 4: Lenalidomide 20 mg maximum tolerated dose (MTD) by oral intake at on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.
| Group | Source count |
|---|---|
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide | 2 |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide | 6 |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide | 6 |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation | 3 |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide | 3 |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide | 2 |
| Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide | 1 |
| Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide | 5.8 | Not reported | 5.2 | 6.4 | Not reported |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide | NA | Not reported | NA | NA | The median was not reached as there were not enough events. |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide | NA | Not reported | NA | NA | The median was not reached as there were not enough events. |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation | 2.1 | Not reported | 1.8 | 2.4 | Not reported |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide | 6.0 | Not reported | 5.7 | 6.3 | Not reported |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide | 3.4 | Not reported | 3.0 | 3.8 | Not reported |
| Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide | 11.7 | Not reported | 11.7 | 11.7 | Not reported |
| Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide | 1.5 | Not reported | 1.1 | 1.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.2
- upper Limit
- 6.4
- value
- 5.8
- comment
- The median was not reached as there were not enough events.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- The median was not reached as there were not enough events.
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- group Id
- OG003
- lower Limit
- 1.8
- upper Limit
- 2.4
- value
- 2.1
- group Id
- OG004
- lower Limit
- 5.7
- upper Limit
- 6.3
- value
- 6.0
- group Id
- OG005
- lower Limit
- 3.0
- upper Limit
- 3.8
- value
- 3.4
- group Id
- OG006
- lower Limit
- 11.7
- upper Limit
- 11.7
- value
- 11.7
- group Id
- OG007
- lower Limit
- 1.1
- upper Limit
- 1.9
- value
- 1.5
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 3
- units
- Participants
- description
- DOR will be determined and reported along with a 95% confidence interval. DOR is measured from the time measurement criteria are met for complete response (CR) or partial response (PR (whichever is recorded first) until the first date that recurrent or progressive disease is objectively documented. Response was measured by the Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria. Complete response (CR) is disappearance of all target lesions and all nodes with long axis \<10mm. Partial response (PR) is a ≥30% decrease in the sum of longest diameters of target lesions but not a CR. Progressive disease is \>20% increase in the sum of longest diameters of target lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- T-cell Malignancies, Dose Escalation, Arm 1, Dose Level -1 Arm 1, Dose Level-1: Lenalidomide 2.5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 200 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
- id
- OG000
- title
- Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide
- description
- T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 1 Arm 1, Dose Level 1: Lenalidomide 5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
- id
- OG001
- title
- Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide
- description
- T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 2 Arm 1, Dose Level 2: Lenalidomide 10 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
- id
- OG002
- title
- Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide
- description
- T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 3 Arm 1, Dose Level 3: Lenalidomide 15 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
- id
- OG003
- title
- Arm 1, Cohort 1, Dose Level 3 Dose Escalation
- description
- T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 4 Arm 1, Dose Level 4: Lenalidomide 20 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).
- id
- OG004
- title
- Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide
- description
- T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 2 Arm 2, Dose Level 2: Lenalidomide by oral intake at maximum tolerated dose (MTD) on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.
- id
- OG005
- title
- Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide
- description
- T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 4 Arm 2, Dose Level 4: Lenalidomide by oral intake at maximum tolerated dose (MTD) Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.
- id
- OG006
- title
- Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide
- description
- T-cell Malignancies, Dose Expansion, Arm 3, Dose Level 4 Arm 3, Dose Level 4: Lenalidomide 20 mg maximum tolerated dose (MTD) by oral intake at on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.
- id
- OG007
- title
- Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- up to a median of 11.7 months
- title
- Duration of Response (DOR) in Months Reported Along With a 95% Confidence Interval
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice