Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Follicular

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Follicular Lymphoma

All Drugs and Chemicals

Antineoplastic Agents

Antirheumatic Agents

Antibodies

Antibodies, Monoclonal

Obinutuzumab

Rituximab

Immunoglobulins

Antineoplastic Agents, Immunological

Immunologic Factors

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.

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.

Duvelisib

Hagop Youssoufian, MD

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.

A Study of Duvelisib in Combination With Rituximab or Obinutuzumab in Subjects With Previously Untreated CD20+ Follicular Lymphoma (CONTEMPO)

A Two-arm, Phase 1b/2 Study of Duvelisib Administered in Combination With Rituximab or Obinutuzumab in Subjects With Previously Untreated CD20+ Follicular Lymphoma (CONTEMPO)

Composite measure of safety, as indicated by Treatment-emergent adverse events (TEAEs) and changes in safety laboratory values. TEAEs assessed as \>=Grade 3.

Plasma concentrations of Duvelisib and IPI-656 (metabolite)

SecuraBio

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.

IPI-145 (duvelisib): PI3K Inhibitor

Obinutuzumab

Duvelisib and Obinutuzumab

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.

IPI-145 (duvelisib): PI3K Inhibitor

Rituximab

Duvelisib and Rituximab

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Belgium

United States

United Kingdom

Italy

France

Spain

Region of Enrollment

Beth Gregory, PharmD, MBA

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.

Duvelisib: PI3K Inhibitor

Obinutuzumab

Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. IPI-145 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.

Duvelisib: PI3K Inhibitor

Rituximab

Number of Subjects With Dose Limiting Toxicities (DLTs) - Part 1

Complete Response Rate (CRR)- Part 2

TEAEs assessed as ≥ Grade 3

TEAEs ≥ Grade 3 assessed as related to duvelisib

TEAEs ≥ Grade 3 assessed as related to anti-CD20

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.

Duvelisib: PI3K Inhibitor

Rituximab

Safety: Composite Measure of Safety, as Indicated by Treatment-emergent Adverse Events (TEAEs) and Changes in Safety Laboratory Values

Complete Response

Partial Response

Stable Disease

Overall Response Rate (ORR)

Data could not be reported because the study was terminated early and a sufficient number of subjects and events were not available for analysis.

Duration of Response (DOR)

The study had been terminated and Overall Survival was not performed.

Overall Survival (OS)

The study had been terminated and PK analysis was not performed.

Pharmacokinetic (PK): Plasma Concentrations of Duvelisib and IPI-656 (Metabolite)

Overall Study

Spots Global Cancer Trial Database for cd20+ follicular lymphoma