TriangleNCT04447027 · OUTCOME
Overall Response Rate (Complete Response + Partial Response)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 6 cycles (each cycle is 28 days)
What was measured
The response rate will be estimated using the Kaplan-Meier curve and reported along with a 95% confidence interval. 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.
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
Complete Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide | 50 | Not reported | 47.3 | 52.7 | Not reported |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide | 16.6 | Not reported | 15.3 | 18.0 | Not reported |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide | 33.3 | Not reported | 31.8 | 34.8 | Not reported |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation | 66 | Not reported | 64.0 | 68.0 | Not reported |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide | 100 | Not reported | 98 | 100 | Not reported |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide | 50 | Not reported | 47.3 | 52.7 | Not reported |
| Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide | 100 | Not reported | 100 | 100 | Not reported |
| Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide | 100 | Not reported | 97.3 | 100 | Not reported |
Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide | 50 | Not reported | 47.3 | 52.7 | Not reported |
| Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide | 0 | Not reported | 0 | 0 | Not reported |
| Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide | 33.3 | Not reported | 31.8 | 34.8 | Not reported |
| Arm 1, Cohort 1, Dose Level 3 Dose Escalation | 66 | Not reported | 64.0 | 68.0 | Not reported |
| Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide | 100 | Not reported | 98 | 100 | Not reported |
| Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide | 50 | Not reported | 47.3 | 52.7 | Not reported |
| Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide | 0 | Not reported | 0 | 0 | Not reported |
| Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide | 50 | Not reported | 47.3 | 52.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 47.3
- upper Limit
- 52.7
- value
- 50
- group Id
- OG001
- lower Limit
- 15.3
- upper Limit
- 18.0
- value
- 16.6
- group Id
- OG002
- lower Limit
- 31.8
- upper Limit
- 34.8
- value
- 33.3
- group Id
- OG003
- lower Limit
- 64.0
- upper Limit
- 68.0
- value
- 66
- group Id
- OG004
- lower Limit
- 98
- upper Limit
- 100
- value
- 100
- group Id
- OG005
- lower Limit
- 47.3
- upper Limit
- 52.7
- value
- 50
- group Id
- OG006
- lower Limit
- 100
- upper Limit
- 100
- value
- 100
- group Id
- OG007
- lower Limit
- 97.3
- upper Limit
- 100
- value
- 100
- title
- Complete Response
- categories
- measurements
- group Id
- OG000
- lower Limit
- 47.3
- upper Limit
- 52.7
- value
- 50
- group Id
- OG001
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- group Id
- OG002
- lower Limit
- 31.8
- upper Limit
- 34.8
- value
- 33.3
- group Id
- OG003
- lower Limit
- 64.0
- upper Limit
- 68.0
- value
- 66
- group Id
- OG004
- lower Limit
- 98
- upper Limit
- 100
- value
- 100
- group Id
- OG005
- lower Limit
- 47.3
- upper Limit
- 52.7
- value
- 50
- group Id
- OG006
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- group Id
- OG007
- lower Limit
- 47.3
- upper Limit
- 52.7
- value
- 50
- title
- Partial Response
- 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
- The response rate will be estimated using the Kaplan-Meier curve and reported along with a 95% confidence interval. 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.
- 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
- NUMBER
- reporting Status
- POSTED
- time Frame
- 6 cycles (each cycle is 28 days)
- title
- Overall Response Rate (Complete Response + Partial Response)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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