A Phase 1/2 interventional study of Duvelisib and Rituximab in CD20+ Follicular Lymphoma, sponsored by SecuraBio. Terminated at 21 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-28.
Sponsored by SecuraBio · Phase 1/2, Interventional, and Treatment
A Two-arm, Phase 1b/2 Study of duvelisib Administered in Combination with Rituximab or Obinutuzumab in Subjects with Previously Untreated CD20+ Follicular Lymphoma.
This is a two-arm, open-label, Phase 1b/2 trial designed to evaluate the safety and efficacy of duvelisib in combination with rituximab and duvelisib in combination with obinutuzumab in subjects with previously untreated CD20+ FL.
The study will be conducted in two parts, a Safety Lead-in (Part 1) followed by a randomized, 2-Stage Design in Part 2. Each treatment arm will be assessed independently for dose limiting toxicity (DLT) within Part 1.
Exclusion Criteria:
Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Rituximab 375 mg/m2 will be administered intravenously (IV) beginning on Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.
Drug: Duvelisib · Drug: Rituximab
Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Duvelisib will be administered orally, twice daily, in 28-day cycles. Obinutuzumab 1000 mg will be administered intravenously (IV) beginning at Cycle 1 (28 day cycles); days 1, 8, 15 and 22. Thereafter, infusions will occur on Day 1 of the even cycles treatment; Cycles 4-26.
Drug: Duvelisib · Drug: Obinutuzumab
PI3K Inhibitor
Also known as: Copiktra, IPI-145
monoclonal antibody
Also known as: Rituxan/MabThera®
monoclonal antibody
Also known as: GAZYVA/GAZYVARO™
Number of Subjects With Dose Limiting Toxicities (DLTs) - Part 1
Time frame: 28 days from first dose of study treatment
Complete Response Rate (CRR)- Part 2
Time frame: Up to 2 years from the first dose of study treatment
Safety: Composite Measure of Safety, as Indicated by Treatment-emergent Adverse Events (TEAEs) and Changes in Safety Laboratory Values
Composite measure of safety, as indicated by Treatment-emergent adverse events (TEAEs) and changes in safety laboratory values. TEAEs assessed as \>=Grade 3.
Time frame: Up to 30 days after the last dose of study treatment
Overall Response Rate (ORR)
Time frame: Up to 2 years from the first dose of study treatment
Duration of Response (DOR)
The median DOR was non-estimable.
Time frame: Up to 2 years from the first dose of study treatment
Overall Survival (OS)
Time frame: Up to 2 years from the first dose of study treatment
Pharmacokinetic (PK): Plasma Concentrations of Duvelisib and IPI-656 (Metabolite)
Plasma concentrations of Duvelisib and IPI-656 (metabolite)
Time frame: Every 4 weeks for 16 weeks
| Milestone | Duvelisib and Obinutuzumab | Duvelisib and Rituximab |
|---|---|---|
| Started | 27 | 28 |
| Completed | 1 | 0 |
| Not completed | 26 | 28 |
| Withdrew: Death | 0 | 2 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Termination of study by sponsor | 20 | 20 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Other reasons | 6 | 4 |
| Participants | Duvelisib and Obinutuzumab | Duvelisib and Rituximab |
|---|---|---|
| Number of Subjects With Dose Limiting Toxicities (DLTs) - Part 1 | 1 | 0 |
| Participants | Duvelisib and Obinutuzumab | Duvelisib and Rituximab |
|---|---|---|
| Complete Response Rate (CRR)- Part 2 | 11 | 10 |
Composite measure of safety, as indicated by Treatment-emergent adverse events (TEAEs) and changes in safety laboratory values. TEAEs assessed as \>=Grade 3.
| Participants | Duvelisib and Obinutuzumab | Duvelisib and Rituximab |
|---|---|---|
| TEAEs assessed as ≥ Grade 3 | 24 | 19 |
| TEAEs ≥ Grade 3 assessed as related to duvelisib | 23 | 17 |
| TEAEs ≥ Grade 3 assessed as related to anti-CD20 | 11 | 2 |
| participants | Duvelisib and Obinutuzumab | Duvelisib and Rituximab |
|---|---|---|
| Complete Response | 11 | 10 |
| Partial Response | 13 | 16 |
| Stable Disease | 1 | 0 |
The median DOR was non-estimable.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Plasma concentrations of Duvelisib and IPI-656 (metabolite)
No measurements were reported for this outcome.
Collected over 35 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Duvelisib and Obinutuzumab | 0/27 (0%) | 16/27 (59.3%) | 26/27 (96.3%) |
| Duvelisib and Rituximab | 1/28 (3.6%) | 10/28 (35.7%) | 27/28 (96.4%) |
| Event | Duvelisib and Obinutuzumab | Duvelisib and Rituximab |
|---|---|---|
| PyrexiaGeneral disorders | 4/27 | 2/28 |
| DiarrhoeaGastrointestinal disorders | 2/27 | 4/28 |
| ColitisGastrointestinal disorders | 2/27 | 1/28 |
| Alanine aminotransferase increasedInvestigations | 2/27 | 0/28 |
| RashSkin and subcutaneous tissue disorders | 2/27 | 1/28 |
| Febrile NeutropeniaBlood and lymphatic system disorders | 1/27 | 0/28 |
| OdynophagiaGastrointestinal disorders | 1/27 | 0/28 |
| StomatitisGastrointestinal disorders | 1/27 | 0/28 |
| FatigueGeneral disorders | 1/27 | 0/28 |
| Mucosal InflammationGeneral disorders | 1/27 | 0/28 |
| Event | Duvelisib and Obinutuzumab | Duvelisib and Rituximab |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 11/27 | 16/28 |
| Alanine aminotransferase increasedInvestigations | 13/27 | 9/28 |
| Aspartate aminotransferase increasedInvestigations | 13/27 | 8/28 |
| NauseaGastrointestinal disorders | 12/27 | 7/28 |
| FatigueGeneral disorders | 8/27 | 9/28 |
| Abdominal PainGastrointestinal disorders | 8/27 | 5/28 |
| VomitingGastrointestinal disorders | 8/27 | 3/28 |
| PyrexiaGeneral disorders | 8/27 | 6/28 |
| RashSkin and subcutaneous tissue disorders | 7/27 | 7/28 |
| CoughRespiratory, thoracic and mediastinal disorders | 6/27 | 7/28 |
| Age, Categorical(Participants) | Duvelisib and Obinutuzumab | Duvelisib and Rituximab | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 16 | 20 | 36 |
| >=65 years | 11 | 8 | 19 |
| Age, Continuous(years) | Duvelisib and Obinutuzumab | Duvelisib and Rituximab | Total |
|---|---|---|---|
| Mean | 58.4 ± 12.32 | 58.2 ± 10.65 | 58.3 ± 11.39 |
| Sex: Female, Male(Participants) | Duvelisib and Obinutuzumab | Duvelisib and Rituximab | Total |
|---|---|---|---|
| Female | 16 | 10 | 26 |
| Male | 11 | 18 | 29 |
| Region of Enrollment(participants) | Duvelisib and Obinutuzumab | Duvelisib and Rituximab | Total |
|---|---|---|---|
| Belgium | 6 | 3 | 9 |
| United States | 10 | 9 | 19 |
| United Kingdom | 3 | 2 | 5 |
| Italy | 1 | 1 | 2 |
| France | 3 | 4 | 7 |
| Spain | 4 | 9 | 13 |
This study is terminated, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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