Clinical trial NCT02391545: A Study of Duvelisib in Combination With Rituximab or Obinutuzumab in Subjects With Previously Untreated CD20+ Follicular Lymphoma (CONTEMPO)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: CD20+ Follicular Lymphoma
Keywords: Follicular Lymphoma
Previously Untreated
Lead sponsor: SecuraBio
Sponsor class: INDUSTRY
First posted: 2015-03-18
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Subjects With Dose Limiting Toxicities (DLTs) - Part 1
timeFrame: 28 days from first dose of study treatment
measure: Complete Response Rate (CRR)- Part 2
timeFrame: Up to 2 years from the first dose of study treatment
Secondary outcomes:
measure: Safety: Composite Measure of Safety, as Indicated by Treatment-emergent Adverse Events (TEAEs) and Changes in Safety Laboratory Values
timeFrame: Up to 30 days after the last dose of study treatment
measure: Overall Response Rate (ORR)
timeFrame: Up to 2 years from the first dose of study treatment
measure: Duration of Response (DOR)
timeFrame: Up to 2 years from the first dose of study treatment
measure: Overall Survival (OS)
timeFrame: Up to 2 years from the first dose of study treatment
measure: Pharmacokinetic (PK): Plasma Concentrations of Duvelisib and IPI-656 (Metabolite)
timeFrame: Every 4 weeks for 16 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Palo Alto
country: United States
state: California
city: Hackensack
country: United States
state: New Jersey
city: Rochester
country: United States
state: New York
city: Dallas
country: United States
state: Texas
city: Kortrijk
country: Belgium
city: Leuven
country: Belgium
city: Wilrijk
country: Belgium
city: Clermont-Ferrand
country: France
city: Marseille Cedex 05
country: France
city: Pessac
country: France
city: Rouen Cedex 1
country: France
city: Tours Cedex 01
country: France
city: Bologna
country: Italy
city: Varese
country: Italy
city: Badalona
country: Spain
state: Barcelona
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Salamanca
country: Spain
city: Leeds
country: United Kingdom
city: London
country: United Kingdom
Study officials:
affiliation: Verastem, Inc.
name: Hagop Youssoufian, MD
role: STUDY_CHAIR
References: