TriangleNCT05011058 · OUTCOME
Objective Response Rate (ORR) by Study Milestone in the Peripheral T-Cell Lymphoma (Combination Therapy) Cohort That Enrolled Patients Beyond Stage 1 or in the Peripheral T-Cell Lymphoma (Monotherapy) Cohort Who Crossed Over to Receive Combination Therapy
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 approximately 2 years
What was measured
Number (percentage) of patients with a best overall complete response (CR) or partial response (PR) according to the 2007 International Working Group (IWG) criteria, where CR included complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy with all lymph nodes and nodal masses having regressed on computed tomography to normal size, and PR included at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses, no increase should have been observed in the size of other nodes, liver, or spleen, and splenic and hepatic nodules must have regressed by ≥ 50% in their SPD or, for single nodules, in the greatest transverse diameter.
Analysis population: Intent-to-Treat Analysis Set, defined as all patients who were enrolled into the trial regardless of whether or not they received study treatment. The sum of the Overall Number of Participants Analyzed across all subgroups (ie, 57) additionally includes pre-specified ORR analyses in a subset of 14 patients in the Peripheral T-Cell Lymphoma (Combination Therapy) cohort previously treated with only 1 line of anti-lymphoma therapy.
Groups in this outcome
Stage 1 (Peripheral T-Cell Lymphoma)
Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD in the first stage of the study
Stage 1 (Peripheral T-Cell Lymphoma - Second Line)
Patients with second-line relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD in the first stage of the study
Stage 2 (Peripheral T-Cell Lymphoma)
Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD in the second stage of the study
Stage 2 (Peripheral T-Cell Lymphoma - Second Line)
Patients with second-line relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD in the second stage of the study
Expansion (Peripheral T-Cell Lymphoma)
Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD in the expansion stage of the study
Expansion (Peripheral T-Cell Lymphoma - Second Line)
Patients with second-line relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD in the expansion stage of the study
Crossover (Peripheral T-Cell Lymphoma)
Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD after having been treated with nanatinostat 20 mg QD on Days 1 to 4 per week without response in the monotherapy cohort
| Group | Source count |
|---|---|
| Stage 1 (Peripheral T-Cell Lymphoma) | 10 |
| Stage 1 (Peripheral T-Cell Lymphoma - Second Line) | 5 |
| Stage 2 (Peripheral T-Cell Lymphoma) | 11 |
| Stage 2 (Peripheral T-Cell Lymphoma - Second Line) | 4 |
| Expansion (Peripheral T-Cell Lymphoma) | 17 |
| Expansion (Peripheral T-Cell Lymphoma - Second Line) | 5 |
| Crossover (Peripheral T-Cell Lymphoma) | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stage 1 (Peripheral T-Cell Lymphoma) | 5 | Not reported | Not reported | Not reported | Not reported |
| Stage 1 (Peripheral T-Cell Lymphoma - Second Line) | 5 | Not reported | Not reported | Not reported | Not reported |
| Stage 2 (Peripheral T-Cell Lymphoma) | 2 | Not reported | Not reported | Not reported | Not reported |
| Stage 2 (Peripheral T-Cell Lymphoma - Second Line) | 1 | Not reported | Not reported | Not reported | Not reported |
| Expansion (Peripheral T-Cell Lymphoma) | 4 | Not reported | Not reported | Not reported | Not reported |
| Expansion (Peripheral T-Cell Lymphoma - Second Line) | 1 | Not reported | Not reported | Not reported | Not reported |
| Crossover (Peripheral T-Cell Lymphoma) | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 11
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 17
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 5
- units
- Participants
- description
- Number (percentage) of patients with a best overall complete response (CR) or partial response (PR) according to the 2007 International Working Group (IWG) criteria, where CR included complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy with all lymph nodes and nodal masses having regressed on computed tomography to normal size, and PR included at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses, no increase should have been observed in the size of other nodes, liver, or spleen, and splenic and hepatic nodules must have regressed by ≥ 50% in their SPD or, for single nodules, in the greatest transverse diameter.
- groups
- description
- Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD in the first stage of the study
- id
- OG000
- title
- Stage 1 (Peripheral T-Cell Lymphoma)
- description
- Patients with second-line relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD in the first stage of the study
- id
- OG001
- title
- Stage 1 (Peripheral T-Cell Lymphoma - Second Line)
- description
- Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD in the second stage of the study
- id
- OG002
- title
- Stage 2 (Peripheral T-Cell Lymphoma)
- description
- Patients with second-line relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD in the second stage of the study
- id
- OG003
- title
- Stage 2 (Peripheral T-Cell Lymphoma - Second Line)
- description
- Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD in the expansion stage of the study
- id
- OG004
- title
- Expansion (Peripheral T-Cell Lymphoma)
- description
- Patients with second-line relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD in the expansion stage of the study
- id
- OG005
- title
- Expansion (Peripheral T-Cell Lymphoma - Second Line)
- description
- Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD after having been treated with nanatinostat 20 mg QD on Days 1 to 4 per week without response in the monotherapy cohort
- id
- OG006
- title
- Crossover (Peripheral T-Cell Lymphoma)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Intent-to-Treat Analysis Set, defined as all patients who were enrolled into the trial regardless of whether or not they received study treatment. The sum of the Overall Number of Participants Analyzed across all subgroups (ie, 57) additionally includes pre-specified ORR analyses in a subset of 14 patients in the Peripheral T-Cell Lymphoma (Combination Therapy) cohort previously treated with only 1 line of anti-lymphoma therapy.
- reporting Status
- POSTED
- time Frame
- Up to approximately 2 years
- title
- Objective Response Rate (ORR) by Study Milestone in the Peripheral T-Cell Lymphoma (Combination Therapy) Cohort That Enrolled Patients Beyond Stage 1 or in the Peripheral T-Cell Lymphoma (Monotherapy) Cohort Who Crossed Over to Receive Combination Therapy
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice