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

Phase 1

Terminated

• Conditions: CD20+ Follicular Lymphoma
• Interventions: Drug: Duvelisib; Drug: Rituximab; Drug: Obinutuzumab

• Registration Number: NCT02391545
• Lead Sponsor: SecuraBio

Brief Summary

A Two-arm, Phase 1b/2 Study of duvelisib Administered in Combination with Rituximab or Obinutuzumab in Subjects with Previously Untreated CD20+ Follicular Lymphoma.

Detailed Description

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.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-03-03
• Study First Submitted QC: 2015-03-17
• Study First Posted: 2015-03-18
• Primary Completion: 2017-01-17
• Study Completion: 2017-05
• Disposition First Submitted: 2018-05-02
• Disposition First Submitted QC: 2018-05-02
• Disposition First Posted: 2018-05-04
• Results First Submitted: 2018-10-23
• Results First Submitted QC: 2019-01-04
• Results First Posted: 2019-01-08
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-07
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• Diagnosis of CD20+, follicular lymphoma that has not been treated
• CD20-immunophenotyping of tumor to document B-cell follicular lymphoma
• Stage II disease with bulky disease (≥ 7cm lesion), Stage III, or Stage IV disease
• Disease that requires treatment based on the Investigator's opinion (e.g., meets GELF criteria)
• At least one measurable lesion that is > 1.5 cm in at least one dimension
• Eastern Cooperative Oncology Group (ECOG) performance status <=2 (corresponds to Karnofsky Performance Status [KPS] >=60%)

Exclusion Criteria

• Received systemic treatment for lymphoma such as chemotherapy, immunotherapy, radiotherapy, investigational agents, or radioimmunotherapy.
• Clinical evidence of transformation to a more aggressive subtype of lymphoma or grade 3B follicular lymphoma
• Severe allergic or anaphylactic reaction to any monoclonal antibody therapy, murine protein, or known hypersensitivity to any of the study drugs
• Prior allogeneic hematopoietic stem cell transplant
• Prior, current or chronic hepatitis B or hepatitis C infection
• Human immunodeficiency virus (HIV) infection or Human T Cell Lymphotropic Virus 1 (HTLV-1) infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Duvelisib and Rituximab	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. 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 and Rituximab	Duvelisib	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 and Obinutuzumab	Duvelisib	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 and Obinutuzumab	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. 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.

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Dose Limiting Toxicities (DLTs) - Part 1	28 days from first dose of study treatment
Complete Response Rate (CRR)- Part 2	Up to 2 years from the first dose of study treatment

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)	Up to 2 years from the first dose of study treatment
Duration of Response (DOR)	Up to 2 years from the first dose of study treatment	The median DOR was non-estimable.
Overall Survival (OS)	Up to 2 years from the first dose of study treatment
Pharmacokinetic (PK): Plasma Concentrations of Duvelisib and IPI-656 (Metabolite)	Every 4 weeks for 16 weeks	Plasma concentrations of Duvelisib and IPI-656 (metabolite)
Safety: Composite Measure of Safety, as Indicated by Treatment-emergent Adverse Events (TEAEs) and Changes in Safety Laboratory Values	Up to 30 days after the last dose of study treatment	Composite measure of safety, as indicated by Treatment-emergent adverse events (TEAEs) and changes in safety laboratory values. TEAEs assessed as \>=Grade 3.