Trials Sponsors Conditions Drugs Pricing

Conditions

CD20+ Follicular Lymphoma

Keywords

Follicular LymphomaPreviously Untreated

Outcome Measures

Primary Outcomes (2)

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 Outcomes (5)

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
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
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

Study Arms (2)

Duvelisib and Rituximab

EXPERIMENTAL

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: DuvelisibDrug: Rituximab

Duvelisib and Obinutuzumab

EXPERIMENTAL

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: DuvelisibDrug: Obinutuzumab

Interventions

DuvelisibDrug

PI3K Inhibitor

Also known as: Copiktra, IPI-145

Duvelisib and ObinutuzumabDuvelisib and Rituximab

RituximabDrug

monoclonal antibody

Also known as:

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Diagnosis of CD20+, follicular lymphoma that has not been treated
CD20-immunophenotyping of tumor to document B-cell follicular lymphoma

Sponsors & Collaborators

SecuraBio
Industrylead

Study Sites (21)

Los Angeles, California, 90095, United States

Palo Alto, California, 94304, United States

Hackensack, New Jersey, 07601, United States

Rochester, New York, 14642, United States

Dallas, Texas, 75246, United States

Kortrijk, 8000, Belgium

Leuven, 3000, Belgium

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

duvelisibRituximabobinutuzumab

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Results Point of Contact

Title: Beth Gregory, PharmD, MBA
Organization: Secura Bio, Inc.

Study Officials

Hagop Youssoufian, MD
Verastem, Inc.
STUDY CHAIR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: Yes

Enrollment

55 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 3, 2015

First Posted

March 18, 2015

Study Start

December 2014

Date type not reported

This date has not been verified as actual or estimated.

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (5)

Study Arms (2)

Duvelisib and Rituximab

Duvelisib and Obinutuzumab

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (21)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (5)

Study Arms (2)

Duvelisib and Rituximab

Duvelisib and Obinutuzumab

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (21)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations