NCT02391545

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2014

Typical duration for phase_1

Geographic Reach
6 countries

21 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 18, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

January 8, 2019

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

2.1 years

First QC Date

March 3, 2015

Results QC Date

October 23, 2018

Last Update Submit

September 7, 2023

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: Rituxan/MabThera®
Duvelisib and Rituximab
ObinutuzumabDRUG

monoclonal antibody

Also known as: GAZYVA/GAZYVARO™
Duvelisib and Obinutuzumab

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
  • 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%)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Unknown Facility

Los Angeles, California, 90095, United States

Location

Unknown Facility

Palo Alto, California, 94304, United States

Location

Unknown Facility

Hackensack, New Jersey, 07601, United States

Location

Unknown Facility

Rochester, New York, 14642, United States

Location

Unknown Facility

Dallas, Texas, 75246, United States

Location

Unknown Facility

Kortrijk, 8000, Belgium

Location

Unknown Facility

Leuven, 3000, Belgium

Location

Unknown Facility

Wilrijk, 2610, Belgium

Location

Unknown Facility

Clermont-Ferrand, 63003, France

Location

Unknown Facility

Marseille, 13385, France

Location

Unknown Facility

Pessac, 33600, France

Location

Unknown Facility

Rouen, 76038, France

Location

Unknown Facility

Tours, 37044, France

Location

Unknown Facility

Bologna, 40138, Italy

Location

Unknown Facility

Varese, 21100, Italy

Location

Unknown Facility

Badalona, Barcelona, 8916, Spain

Location

Unknown Facility

Barcelona, 8097, Spain

Location

Unknown Facility

Madrid, 28222, Spain

Location

Unknown Facility

Salamanca, 37007, Spain

Location

Unknown Facility

Leeds, LS9 7TF, United Kingdom

Location

Unknown Facility

London, NW1 1BU, United Kingdom

Location

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)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Beth Gregory, PharmD, MBA
Organization
Secura Bio, Inc.
bgregory@securabio.com
1-702-254-0011

Study Officials

  • Hagop Youssoufian, MD

    Verastem, Inc.

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
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 1, 2014

Primary Completion

January 17, 2017

Study Completion

May 1, 2017

Last Updated

September 28, 2023

Results First Posted

January 8, 2019

Record last verified: 2023-09

Locations

ES(4)GB(2)IT(2)FR(5)US(5)BE(3)