Trials / Terminated
TerminatedNCT02204982
Study of Duvelisib in Combination With Rituximab vs Rituximab in Subjects With Previously Treated Follicular Lymphoma
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Duvelisib in Combination With Rituximab vs Rituximab in Subjects With Previously Treated Follicular Lymphoma
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- SecuraBio · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A study to evaluate the safety and efficacy of duvelisib administered in combination with rituximab vs placebo in combination with rituximab in patients with previously treated CD20-positive follicular lymphoma who are not suitable candidates for chemotherapy.
Detailed description
Study IPI-145-08 is an international, multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 study designed to evaluate the efficacy and safety of duvelisib in combination with rituximab vs placebo in combination with rituximab in subjects with previously treated CD20-positive follicular lymphoma. Approximately 400 subjects will receive 25 mg of duvelisib or placebo, orally BID for 28 day continuous cycles, in combination with 375 mg/m2 of Rituximab given once weekly for 4 weeks during Cycle 1 and then once on Day 1 of Cycles 4, 6, 8, and 10. Patients will remain on treatment for up to 27 cycles and may continue treatment if clinical benefit is observed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Duvelisib | PI3K Inhibitor |
| DRUG | Placebo | Matching Placebo (25 mg BID) administered orally in 28-day continuous treatment cycles. |
| DRUG | Rituximab | IV infusion of rituximab (375 mg/m2) once weekly for 4 weeks during Cycle 1, then once on Day 1 of Cycles 4, 6, 8, and 10. |
Timeline
- Start date
- 2014-09-01
- Primary completion
- 2016-12-01
- Completion
- 2017-03-01
- First posted
- 2014-07-31
- Last updated
- 2023-09-28
- Results posted
- 2019-01-03
Locations
5 sites across 4 countries: Australia, France, Italy, Poland
Source: ClinicalTrials.gov record NCT02204982. Inclusion in this directory is not an endorsement.