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

September 7, 2023 updated by: SecuraBio

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)

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Kortrijk, Belgium, 8000
      • Leuven, Belgium, 3000
      • Wilrijk, Belgium, 2610
  • France
      • Clermont-Ferrand, France, 63003
      • Marseille Cedex 05, France, 13385
      • Pessac, France, 33600
      • Rouen Cedex 1, France, 76038
      • Tours Cedex 01, France, 37044
  • Italy
      • Bologna, Italy, 40138
      • Varese, Italy, 21100
  • Spain
      • Barcelona, Spain, 8097
      • Madrid, Spain, 28222
      • Salamanca, Spain, 37007
    • Barcelona
      • Badalona, Barcelona, Spain, 8916
  • United Kingdom
      • Leeds, United Kingdom, LS9 7TF
      • London, United Kingdom, NW1 1BU
  • United States
    • California
      • Los Angeles, California, United States, 90095
      • Palo Alto, California, United States, 94304
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
    • New York
      • Rochester, New York, United States, 14642
    • Texas
      • Dallas, Texas, United States, 75246

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Duvelisib and 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.
Drug: Duvelisib
PI3K Inhibitor
Other Names:
  • Copiktra, IPI-145
Drug: Rituximab
monoclonal antibody
Other Names:
  • Rituxan/MabThera®
Experimental: 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.

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
PI3K Inhibitor
Other Names:
  • Copiktra, IPI-145
Drug: Obinutuzumab
monoclonal antibody
Other Names:
  • GAZYVA/GAZYVARO™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Subjects With Dose Limiting Toxicities (DLTs) - Part 1
Time Frame: 28 days from first dose of study treatment
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
Up to 2 years from the first dose of study treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety: Composite Measure of Safety, as Indicated by Treatment-emergent Adverse Events (TEAEs) and Changes in Safety Laboratory Values
Time Frame: 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.
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
Up to 2 years from the first dose of study treatment
Duration of Response (DOR)
Time Frame: Up to 2 years from the first dose of study treatment
The median DOR was non-estimable.
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
Up to 2 years from the first dose of study treatment
Pharmacokinetic (PK): Plasma Concentrations of Duvelisib and IPI-656 (Metabolite)
Time Frame: Every 4 weeks for 16 weeks
Plasma concentrations of Duvelisib and IPI-656 (metabolite)
Every 4 weeks for 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SecuraBio

Investigators

  • Study Chair: Hagop Youssoufian, MD, Verastem, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

January 17, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

March 3, 2015

First Submitted That Met QC Criteria

March 17, 2015

First Posted (Estimated)

March 18, 2015

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 7, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPI-145-19
  • 2014-005459-13 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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