Trials / Completed
CompletedNCT04038359
A Phase 2 Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Participants With Indolent Non-Hodgkin Lymphoma
A Phase 2, Randomized, Open-label, 2-Arm Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Subjects With Indolent Non-Hodgkin Lymphoma (iNHL)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 103 (actual)
- Sponsor
- SecuraBio · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study examined the effects of predefined 2-week duvelisib dose holidays on tumor responses and safety/tolerability.
Detailed description
This was a Phase 2, randomized, open-label, 2-arm study designed to evaluate the efficacy and safety of prescribed drug holidays of duvelisib treatment in participants with relapsed or refractory (R/R) indolent non-Hodgkin lymphoma (iNHL) who have received at least 1 prior systemic therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Duvelisib | Phosphoinositide 3-kinase (PI3K) inhibitor |
Timeline
- Start date
- 2019-09-24
- Primary completion
- 2023-07-24
- Completion
- 2023-07-24
- First posted
- 2019-07-30
- Last updated
- 2024-09-19
- Results posted
- 2024-09-19
Locations
28 sites across 8 countries: United States, Czechia, Germany, Italy, Poland, Russia, South Korea, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04038359. Inclusion in this directory is not an endorsement.