Trial · NCT03372057
A Study of Duvelisib in Participants With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
NCT03372057, Phase 2, Completed, SecuraBio; results first posted 2025-02-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Duvelisib in Participants With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL). Trials, record NCT03372057. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03372057
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Duvelisib in Participants With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
- NCT number
- NCT03372057
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 156 participants, actual
- Lead sponsor
- SecuraBio
- Conditions
- Peripheral T-cell Lymphoma
- Interventions
- Duvelisib, Duvelisib, Duvelisib
- First posted
- 2017-12-13
- Last updated
- 2025-03-07
- Other registries' IDs
- eudract:2019-001123-13
- Results first posted
- 2025-02-28
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) as Assessed by the Investigator Using the Lugano Criteria | 56 days (2 cycles; 28-day cycles) | ORR was defined as the percentage of participants with CR + PR, as assessed by the investigator using the Lugano criteria, for participants receiving the optimal dose of duvelisib for at least one cycle of study therapy. |
| Primary | ORR as Assessed by the Independent Review Committee (IRC) Using the Lugano Criteria | 56 days (2 cycles; 28-day cycles) | ORR was defined as the percentage of participants with CR + PR, as assessed by the IRC using the Lugano criteria, for participants receiving the optimal dose of duvelisib for at least one cycle of study therapy. |
| Secondary | Duration of Response (DOR) as Assessed by the Investigator Using the Lugano Criteria | Up to 70 months | DOR was defined for participants with CR or PR as the time from the date of the first documentation of response (CR or PR) to the date of the first documentation of progressive disease (PD) or death due to any cause. Participants who withdraw from the study for any reason prior to PD and participants who had ongoing response at the time of the data cut were censored at the date of their last response assessment. |
| Secondary | Progression-free Survival (PFS) as Assessed by the Investigator Using the Lugano Criteria | Up to 70 months | PFS was defined as the time from the date of first treatment to the date of the first radiographic disease progression or death due to any cause, whichever occurred first. |
| Secondary | Disease Control Rate (DCR) As Assessed by the Investigator Using the Lugano Criteria | Up to 8 weeks | DCR was defined as the percentage of participants with a best overall response of CR or PR or with a best overall response of stable disease (SD) sustained for at least 8 weeks. |
| Secondary | DOR as Assessed by the IRC Using the Lugano Criteria | Up to 70 months | DOR was defined for participants with CR or PR as the time from the date of the first documentation of response (CR or PR) to the date of the first documentation of PD or death due to any cause. Participants who withdrew from the study for any reason prior to PD and participants who had ongoing response at the time of the data cut were censored at the date of their last response assessment. |
| Secondary | PFS as Assessed by the IRC Using the Lugano Criteria | Up to 70 months | PFS was defined as the time from the date of first treatment to the date of the first radiographic disease progression or death due to any cause, whichever occurred first. |
| Secondary | DCR as Assessed by the IRC Using the Lugano Criteria | Up to 8 weeks | DCR was defined as the percentage of participants with a best overall response of CR or PR or with a best overall response of SD sustained for at least 8 weeks. |
| Secondary | Overall Survival (OS) | Up to 70 months | OS was defined as the time from the date of first treatment to the date of death due to any cause. Participants without documented death were censored at last alive date. |
| Secondary | Plasma Concentration of IPI-145 (Duvelisib) and IPI-656 (Metabolite) | Day 15 of Cycles 1 and 2 (4 hours postdose) (28-day cycles) | Blood samples were taken for the analyses of duvelisib and IPI-656 in plasma at designated time points. Results are reported as nanograms/milliliter (ng/mL). |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) as Assessed by the Investigator Using the Lugano Criteria | 56 days (2 cycles; 28-day cycles) | Dose Optimization Efficacy Set: All participants who received at least one dose of study drug, completed at least one cycle of treatment, and had at least one scan to assess disease response after completion of one cycle of treatment. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. As pre-specified, efficacy analysis using investigator assessment reported for the Dose Optimization Phase only. | percentage of participants | NUMBER |
| PRIMARY | ORR as Assessed by the Independent Review Committee (IRC) Using the Lugano Criteria | 56 days (2 cycles; 28-day cycles) | Modified Intent-to-treat (mITT): all participants who received at least one dose of study drug. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. As pre-specified, efficacy analysis using IRC assessment reported for the Expansion Phase only. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) as Assessed by the Investigator Using the Lugano Criteria | Up to 70 months | Dose Optimization Efficacy Set: All participants who received at least one dose of study drug, completed at least one cycle of treatment, and had at least one scan to assess disease response after completion of one cycle of treatment. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. As pre-specified, efficacy analysis using investigator assessment reported for the Dose Optimization Phase only. | month | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) as Assessed by the Investigator Using the Lugano Criteria | Up to 70 months | Dose Optimization Efficacy Set: All participants who received at least one dose of study drug, completed at least one cycle of treatment, and had at least one scan to assess disease response after completion of one cycle of treatment. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. As pre-specified, efficacy analysis using investigator assessment reported for the Dose Optimization Phase only. | month | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) As Assessed by the Investigator Using the Lugano Criteria | Up to 8 weeks | Dose Optimization Efficacy Set: All participants who received at least one dose of study drug, completed at least one cycle of treatment, and had at least one scan to assess disease response after completion of one cycle of treatment. As pre-specified, efficacy analysis using investigator assessment reported for the Dose Optimization Phase only. | percentage of participants | NUMBER |
| SECONDARY | DOR as Assessed by the IRC Using the Lugano Criteria | Up to 70 months | Modified Intent-to-treat (mITT): all participants who receive at least one dose of study drug. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. As pre-specified, efficacy analysis using IRC assessment reported for the Expansion Phase only. | month | MEDIAN |
| SECONDARY | PFS as Assessed by the IRC Using the Lugano Criteria | Up to 70 months | Modified Intent-to-treat (mITT): all participants who received at least one dose of study drug. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. As pre-specified, efficacy analysis using IRC assessment reported for the Expansion Phase only. | months | MEDIAN |
| SECONDARY | DCR as Assessed by the IRC Using the Lugano Criteria | Up to 8 weeks | Modified Intent-to-treat (mITT): all participants who received at least one dose of study drug. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. As pre-specified, efficacy analysis using IRC assessment reported for the Expansion Phase only. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | Up to 70 months | Dose Optimization Efficacy Set: All participants who received at least one dose of study drug, completed at least one cycle of treatment, and had at least one scan to assess disease response after completion of one cycle of treatment. Modified Intent-to-treat (mITT): all participants who receive at least one dose of study drug. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. | month | MEDIAN |
| SECONDARY | Plasma Concentration of IPI-145 (Duvelisib) and IPI-656 (Metabolite) | Day 15 of Cycles 1 and 2 (4 hours postdose) (28-day cycles) | Safety Analysis Set: all participants who received at least one dose of study drug. Here, 'Overall Number of Participants Analyzed' signifies those who were evaluable for this outcome measure, and 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at the specified time points. | ng/mL | MEAN |
Source ClinicalTrials.gov
Results by group25
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) as Assessed by the Investigator Using the Lugano Criteria | Dose Optimization Phase: Cohort 1 | 53.8 | 95% Confidence Interval 26.7 to 80.9 | percentage of participants | |
| Overall Response Rate (ORR) as Assessed by the Investigator Using the Lugano Criteria | Dose Optimization Phase: Cohort 2 | 53.8 | 95% Confidence Interval 26.7 to 80.9 | percentage of participants | |
| ORR as Assessed by the Independent Review Committee (IRC) Using the Lugano Criteria | Expansion Phase | 48.0 | 95% Confidence Interval 39.1 to 56.8 | percentage of participants | |
| Duration of Response (DOR) as Assessed by the Investigator Using the Lugano Criteria | Dose Optimization Phase: Cohort 1 | 4.22 | 95% Confidence Interval 1.87 to NA | month | |
| Duration of Response (DOR) as Assessed by the Investigator Using the Lugano Criteria | Dose Optimization Phase: Cohort 2 | 3.32 | 95% Confidence Interval 1.77 to NA | month | |
| Progression-free Survival (PFS) as Assessed by the Investigator Using the Lugano Criteria | Dose Optimization Phase: Cohort 1 | 3.55 | 95% Confidence Interval 1.05 to 8.54 | month | |
| Progression-free Survival (PFS) as Assessed by the Investigator Using the Lugano Criteria | Dose Optimization Phase: Cohort 2 | 3.55 | 95% Confidence Interval 1.81 to 13.14 | month | |
| Disease Control Rate (DCR) As Assessed by the Investigator Using the Lugano Criteria | Dose Optimization Phase: Cohort 1 | 61.5 | 95% Confidence Interval 35.1 to 88.0 | percentage of participants | |
| Disease Control Rate (DCR) As Assessed by the Investigator Using the Lugano Criteria | Dose Optimization Phase: Cohort 2 | 61.5 | 95% Confidence Interval 35.1 to 88.0 | percentage of participants | |
| DOR as Assessed by the IRC Using the Lugano Criteria | Expansion Phase | 7.9 | 95% Confidence Interval 6.4 to 21.00 | month |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Dose Optimization Phase | STARTED | Dose Optimization Phase: Cohort 1 | 20 | |
| Dose Optimization Phase | STARTED | Dose Optimization Phase: Cohort 2 | 13 | |
| Dose Optimization Phase | STARTED | Expansion Phase | 0 | |
| Dose Optimization Phase | Received at Least 1 Dose of Study Drug | Dose Optimization Phase: Cohort 1 | 20 | |
| Dose Optimization Phase | Received at Least 1 Dose of Study Drug | Dose Optimization Phase: Cohort 2 | 13 | |
| Dose Optimization Phase | Received at Least 1 Dose of Study Drug | Expansion Phase | 0 | |
| Dose Optimization Phase | COMPLETED | Dose Optimization Phase: Cohort 1 | 0 | |
| Dose Optimization Phase | COMPLETED | Dose Optimization Phase: Cohort 2 | 0 | |
| Dose Optimization Phase | COMPLETED | Expansion Phase | 0 | |
| Dose Optimization Phase | NOT COMPLETED | Dose Optimization Phase: Cohort 1 | 20 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events648
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Dose Optimization Phase: Cohort 1 | 7 | 20 | |
| other | Anaemia | Blood and lymphatic system disorders | Dose Optimization Phase: Cohort 2 | 5 | 13 | |
| other | Anaemia | Blood and lymphatic system disorders | Expansion Phase | 34 | 123 | |
| other | Autoimmune haemolytic anaemia | Blood and lymphatic system disorders | Dose Optimization Phase: Cohort 1 | 0 | 20 | |
| other | Autoimmune haemolytic anaemia | Blood and lymphatic system disorders | Dose Optimization Phase: Cohort 2 | 1 | 13 | |
| other | Autoimmune haemolytic anaemia | Blood and lymphatic system disorders | Expansion Phase | 0 | 123 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Dose Optimization Phase: Cohort 1 | 0 | 20 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Dose Optimization Phase: Cohort 2 | 0 | 13 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Expansion Phase | 7 | 123 | |
| other | Normocytic anaemia | Blood and lymphatic system disorders | Dose Optimization Phase: Cohort 1 | 0 | 20 |
1 to 10 of 648Source ClinicalTrials.gov
See all 648 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Optimization Phase: Cohort 1 | 16 | 20 |
| Total, all-cause mortality | Dose Optimization Phase: Cohort 2 | 11 | 13 |
| Total, all-cause mortality | Expansion Phase | 78 | 123 |
| Total, other adverse events | Dose Optimization Phase: Cohort 1 | 19 | 20 |
| Total, other adverse events | Dose Optimization Phase: Cohort 2 | 13 | 13 |
| Total, other adverse events | Expansion Phase | 121 | 123 |
| Total, serious adverse events | Dose Optimization Phase: Cohort 1 | 14 | 20 |
| Total, serious adverse events | Dose Optimization Phase: Cohort 2 | 9 | 13 |
| Total, serious adverse events | Expansion Phase | 60 | 123 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42018969 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03372057
GET https://conductscience.org/api/trials/v1/NCT03372057/results?page=2