Back to resultsA Study of Duvelisib in Combination With Rituximab or Obinutuzumab in Subjects With Previously Untreated CD20+ Follicular Lymphoma (CONTEMPO)
Primary Purpose
CD20+ Follicular Lymphoma
Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Duvelisib
Rituximab
Obinutuzumab
Sponsored by
About this trial
This is an interventional treatment trial for CD20+ Follicular Lymphoma focused on measuring Follicular Lymphoma, Previously Untreated
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Duvelisib and Rituximab
Duvelisib and Obinutuzumab
Arm Description
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 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.
Outcomes
Primary Outcome Measures
Number of Subjects With Dose Limiting Toxicities (DLTs) - Part 1
Complete Response Rate (CRR)- Part 2
Secondary Outcome Measures
Safety: Composite Measure of Safety, as Indicated by Treatment-emergent Adverse Events (TEAEs) and Changes in Safety Laboratory Values
Composite measure of safety, as indicated by Treatment-emergent adverse events (TEAEs) and changes in safety laboratory values. TEAEs assessed as >=Grade 3.
Overall Response Rate (ORR)
Duration of Response (DOR)
The median DOR was non-estimable.
Overall Survival (OS)
Pharmacokinetic (PK): Plasma Concentrations of Duvelisib and IPI-656 (Metabolite)
Plasma concentrations of Duvelisib and IPI-656 (metabolite)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02391545
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
Sponsor is focusing on studies which can enable registration of duvelisib.
Study Start Date
December 2014 (undefined)
Primary Completion Date
January 17, 2017 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SecuraBio
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CD20+ Follicular Lymphoma
Keywords
Follicular Lymphoma, Previously Untreated
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Duvelisib and Rituximab
Arm Type
Experimental
Arm Description
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.
Arm Title
Duvelisib and Obinutuzumab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Duvelisib
Other Intervention Name(s)
Copiktra, IPI-145
Intervention Description
PI3K Inhibitor
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Rituxan/MabThera®
Intervention Description
monoclonal antibody
Intervention Type
Drug
Intervention Name(s)
Obinutuzumab
Other Intervention Name(s)
GAZYVA/GAZYVARO™
Intervention Description
monoclonal antibody
Primary Outcome Measure Information:
Title
Number of Subjects With Dose Limiting Toxicities (DLTs) - Part 1
Time Frame
28 days from first dose of study treatment
Title
Complete Response Rate (CRR)- Part 2
Time Frame
Up to 2 years from the first dose of study treatment
Secondary Outcome Measure Information:
Title
Safety: Composite Measure of Safety, as Indicated by Treatment-emergent Adverse Events (TEAEs) and Changes in Safety Laboratory Values
Description
Composite measure of safety, as indicated by Treatment-emergent adverse events (TEAEs) and changes in safety laboratory values. TEAEs assessed as >=Grade 3.
Time Frame
Up to 30 days after the last dose of study treatment
Title
Overall Response Rate (ORR)
Time Frame
Up to 2 years from the first dose of study treatment
Title
Duration of Response (DOR)
Description
The median DOR was non-estimable.
Time Frame
Up to 2 years from the first dose of study treatment
Title
Overall Survival (OS)
Time Frame
Up to 2 years from the first dose of study treatment
Title
Pharmacokinetic (PK): Plasma Concentrations of Duvelisib and IPI-656 (Metabolite)
Description
Plasma concentrations of Duvelisib and IPI-656 (metabolite)
Time Frame
Every 4 weeks for 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hagop Youssoufian, MD
Organizational Affiliation
Verastem, Inc.
Official's Role
Study Chair
Facility Information:
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
City
Kortrijk
ZIP/Postal Code
8000
Country
Belgium
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
City
Marseille Cedex 05
ZIP/Postal Code
13385
Country
France
City
Pessac
ZIP/Postal Code
33600
Country
France
City
Rouen Cedex 1
ZIP/Postal Code
76038
Country
France
City
Tours Cedex 01
ZIP/Postal Code
37044
Country
France
City
Bologna
ZIP/Postal Code
40138
Country
Italy
City
Varese
ZIP/Postal Code
21100
Country
Italy
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
8916
Country
Spain
City
Barcelona
ZIP/Postal Code
8097
Country
Spain
City
Madrid
ZIP/Postal Code
28222
Country
Spain
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
City
London
ZIP/Postal Code
NW1 1BU
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study of Duvelisib in Combination With Rituximab or Obinutuzumab in Subjects With Previously Untreated CD20+ Follicular Lymphoma (CONTEMPO)
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