18 and older, any sex, with Peripheral T-cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Response Rate (ORR) as Assessed by the Investigator Using the Lugano CriteriaPrimary· 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.
Group
Value
95% CI
Dose Optimization Phase: Cohort 1
53.8
26.7 – 80.9
Dose Optimization Phase: Cohort 2
53.8
26.7 – 80.9
ORR as Assessed by the Independent Review Committee (IRC) Using the Lugano CriteriaPrimary· 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.
Group
Value
95% CI
Expansion Phase
48.0
39.1 – 56.8
Duration of Response (DOR) as Assessed by the Investigator Using the Lugano CriteriaSecondary· 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.
Group
Value
95% CI
Dose Optimization Phase: Cohort 1
4.22
1.87 – NA
Dose Optimization Phase: Cohort 2
3.32
1.77 – NA
Progression-free Survival (PFS) as Assessed by the Investigator Using the Lugano CriteriaSecondary· 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.
Group
Value
95% CI
Dose Optimization Phase: Cohort 1
3.55
1.05 – 8.54
Dose Optimization Phase: Cohort 2
3.55
1.81 – 13.14
Disease Control Rate (DCR) As Assessed by the Investigator Using the Lugano CriteriaSecondary· 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.
Group
Value
95% CI
Dose Optimization Phase: Cohort 1
61.5
35.1 – 88.0
Dose Optimization Phase: Cohort 2
61.5
35.1 – 88.0
DOR as Assessed by the IRC Using the Lugano CriteriaSecondary· 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.
Group
Value
95% CI
Expansion Phase
7.9
6.4 – 21.00
PFS as Assessed by the IRC Using the Lugano CriteriaSecondary· 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.
Group
Value
95% CI
Expansion Phase
3.4
1.8 – 3.9
DCR as Assessed by the IRC Using the Lugano CriteriaSecondary· 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.
Group
Value
95% CI
Expansion Phase
49.6
40.8 – 58.4
Overall Survival (OS)Secondary· 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.
Group
Value
95% CI
Dose Optimization Phase: Cohort 1
6.70
5.22 – NA
Dose Optimization Phase: Cohort 2
10.58
6.67 – 44.62
Expansion Phase
12.4
8.4 – 22.7
Plasma Concentration of IPI-145 (Duvelisib) and IPI-656 (Metabolite)Secondary· 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).
Duvelisib: Cycle 1, Day 15
Group
Value
95% CI
Dose Optimization Phase: Cohort 1
1238.1
± 787.53
Dose Optimization Phase: Cohort 2
2070.0
± 889.39
Expansion Phase
2873.7
± 1709.15
Duvelisib: Cycle 2, Day 15
Group
Value
95% CI
Dose Optimization Phase: Cohort 1
1492.5
± 1019.10
Expansion Phase
2648.2
± 1336.94
Metabolite (IPI-156): Cycle 1, Day 15
Group
Value
95% CI
Dose Optimization Phase: Cohort 1
1310.4
± 1408.99
Dose Optimization Phase: Cohort 2
1580.9
± 772.13
Expansion Phase
2387.5
± 1919.33
Metabolite (IPI-156): Cycle 2, Day 15
Group
Value
95% CI
Dose Optimization Phase: Cohort 1
894.8
± 441.55
Expansion Phase
2427.0
± 1655.89
Adverse events — posted to ClinicalTrials.gov
Time frame: From start of treatment (Day 1) to end of study (70 months).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Dose Optimization Phase: Cohort 1
Serious: 14/20 (70%)
Deaths: 16/20
Dose Optimization Phase: Cohort 2
Serious: 9/13 (69%)
Deaths: 11/13
Expansion Phase
Serious: 60/123 (49%)
Deaths: 78/123
Serious adverse events (86 terms)
Reaction
System
Dose Optimization Phase: C…
Dose Optimization Phase: C…
Expansion Phase
Disease progression
General disorders
—
—
—
Diarrhoea
Gastrointestinal disorders
—
—
—
Pyrexia
General disorders
—
—
—
Pneumonia
Infections and infestations
—
—
—
Sepsis
Infections and infestations
—
—
—
Aspartate aminotransferase increased
Investigations
—
—
—
Alanine aminotransferase increased
Investigations
—
—
—
Febrile neutropenia
Blood and lymphatic system disorders
—
—
—
Atrial fibrillation
Cardiac disorders
—
—
—
Colitis
Gastrointestinal disorders
—
—
—
COVID-19 pneumonia
Infections and infestations
—
—
—
Urinary tract infection
Infections and infestations
—
—
—
Hyponatraemia
Metabolism and nutrition disorders
—
—
—
Dehydration
Metabolism and nutrition disorders
—
—
—
Acute kidney injury
Renal and urinary disorders
—
—
—
Respiratory failure
Respiratory, thoracic and mediastinal disorders
—
—
—
Dyspnoea
Respiratory, thoracic and mediastinal disorders
—
—
—
Hypoxia
Respiratory, thoracic and mediastinal disorders
—
—
—
Anaemia
Blood and lymphatic system disorders
—
—
—
Autoimmune haemolytic anaemia
Blood and lymphatic system disorders
—
—
—
Sinus tachycardia
Cardiac disorders
—
—
—
Cardiac arrest
Cardiac disorders
—
—
—
Cardiac failure
Cardiac disorders
—
—
—
Tachycardia
Cardiac disorders
—
—
—
Abdominal pain
Gastrointestinal disorders
—
—
—
Other adverse events (130 terms — click to expand)
This is a multi-center, parallel cohort, open-label, Phase 2 study of duvelisib, an oral dual inhibitor of phosphoinositide-3-kinase-delta, gamma (PI3K-δ,γ), in participants with relapsed/refractory peripheral T-cell lymphoma (PTCL).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07293403 — Duvelisib Maintenance for the Treatment of Peripheral T-Cell Lymphomas
· Phase 2
· not yet recruiting
NCT07001384 — A Study of Alectinib and Duvelisib in People With Anaplastic Lymphoma Kinase-Positive Anaplastic Large Cell Lymphoma (AL
· Phase 1
· recruiting
NCT06810778 — Duvelisib and Venetoclax in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
· Phase 1, PHASE2
· recruiting
NCT05923502 — (CHANT)Real World Study of Duvelisib in the Treatment of Non-Hodgkin's Lymphoma (NHL)
· not yet recruiting
NCT04639843 — Doxorubicin, CC-(486) (5-azacitidine), Romidepsin, and Duvelisib (hARD) for T-cell Lymphoma
· Phase 1
· withdrawn
Other recruiting trials for Peripheral T-cell Lymphoma
Currently open trials in the same condition.
NCT07523555 — Adaptive Dual-Target CAR-T Cells for Relapsed or Refractory Hematologic Malignancies
· Phase 1, PHASE2
· recruiting
NCT06914037 — A Clinical Study of CHT101 in CD70-Positive Relapsed or Refractory Hematological Malignancies
· Phase 1
· recruiting
NCT07072221 — Bendamustine Combined With Chidamide and Lenalidomide for Relapsed and Refractory PTCL Patients
· NA
· recruiting
NCT06739265 — Golidocitinib Plus CHOP in Newly Diagnosed PTCL
· Phase 1, PHASE2
· recruiting
Other SecuraBio trials
Trials by the same sponsor.
NCT04193293 — A Study of Duvelisib in Combination With Pembrolizumab in Head and Neck Cancer
· Phase 1, PHASE2
· terminated
NCT04342117 — Observational Trial of Real-World Treatment Utilization and Effectiveness of PI3K-inhibitors in CLL/SLL and FL
· terminated
NCT04038359 — A Phase 2 Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Participants With Indolent Non-Hodgkin Lymphom
· Phase 2
· completed
NCT01882803 — A Study of Duvelisib in Participants With Refractory Indolent Non-Hodgkin Lymphoma
· Phase 2
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by SecuraBio
Last refreshed: 7 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03372057.