CD20+ Follicular LymphomaPhase 1/2NCT02391545
A Study of Duvelisib in Combination With Rituximab or Obinutuzumab in Subjects With Previously Untreated CD20+ Follicular Lymphoma (CONTEMPO)
A Phase 1/2 study testing Duvelisib, Rituximab and Obinutuzumab in people with CD20+ Follicular Lymphoma, run by SecuraBio at 21 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CD20+ Follicular Lymphoma
- What is being tested?
- Duvelisib, Rituximab and Obinutuzumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 21 sitesin 6 countries
- Study dates
- Dec 2014to May 2017
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%)
Who cannot join
- 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
Trial locations and contacts
21 sites in 6 countries.
21 sites in 6 countries
United States5 sites
Study site
Dallas, Texas, 75246
Study site
Hackensack, New Jersey, 07601
Study site
Los Angeles, California, 90095
Study site
Palo Alto, California, 94304
Study site
Rochester, New York, 14642
France5 sites
Study site
Clermont-Ferrand, 63003
Study site
Marseille, 13385
Study site
Pessac, 33600
Study site
Rouen, 76038
Study site
Tours, 37044
Spain4 sites
Study site
Badalona, Barcelona, 8916
Study site
Barcelona, 8097
Study site
Madrid, 28222
Study site
Salamanca, 37007
Belgium3 sites
Study site
Kortrijk, 8000
Study site
Leuven, 3000
Study site
Wilrijk, 2610
United Kingdom2 sites
Study site
Leeds, LS9 7TF
Study site
London, NW1 1BU
About this study
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)
A Two-arm, Phase 1b/2 Study of duvelisib Administered in Combination with Rituximab or Obinutuzumab in Subjects with Previously Untreated CD20+ Follicular Lymphoma.
Read the 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.
- Conditions
- CD20+ Follicular Lymphoma
- Being tested
- Duvelisib, Rituximab, Obinutuzumab
- Keywords
- Follicular Lymphoma, Previously Untreated
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuvelisibDrug
Also called Copiktra, IPI-145
PI3K Inhibitor
RituximabDrug
Also called Rituxan/MabThera®
monoclonal antibody
ObinutuzumabDrug
Also called GAZYVA/GAZYVARO™
monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Duvelisib; Drug: 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. Receives: Drug: Duvelisib; Drug: Obinutuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Dose Limiting Toxicities (DLTs) - Part 1
Measured: 28 days from first dose of study treatment
Complete Response Rate (CRR)- Part 2
Measured: 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
Composite measure of safety, as indicated by Treatment-emergent adverse events (TEAEs) and changes in safety laboratory values. TEAEs assessed as >=Grade 3.
Measured: Up to 30 days after the last dose of study treatment
Overall Response Rate (ORR)
Measured: Up to 2 years from the first dose of study treatment
Duration of Response (DOR)
The median DOR was non-estimable.
Measured: Up to 2 years from the first dose of study treatment
Overall Survival (OS)
Measured: Up to 2 years from the first dose of study treatment
Pharmacokinetic (PK): Plasma Concentrations of Duvelisib and IPI-656 (Metabolite)
Plasma concentrations of Duvelisib and IPI-656 (metabolite)
Measured: Every 4 weeks for 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startDec 2014
- Primary completion17 Jan 2017
- Study completionMay 2017
Why it stopped: Sponsor is focusing on studies which can enable registration of duvelisib.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CD20+ Follicular LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- SecuraBio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hagop Youssoufian, MD, Study chair, Verastem, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02391545
- Sponsor's protocol ID
- IPI-145-19
- Other IDs
- 2014-005459-13, 2014
- Status last verified
- Sep 2023
- First submitted
- 3 Mar 2015
- Last updated
- 28 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02391545
- Acronym / sponsor ID
- IPI-145-19
- Conditions
- CD20+ Follicular Lymphoma
- Keywords
- Follicular Lymphoma, Previously Untreated
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor is focusing on studies which can enable registration of duvelisib.
- Enrolment
- 55 participants (actual)
- Lead sponsor
- SecuraBioIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- 17 Jan 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 18 Mar 2015 (estimated)
- Results
- Posted 8 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duvelisib and Rituximab | Experimental | Drug: Duvelisib, Drug: RituximabDuvelisib 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 and Obinutuzumab | Experimental | Drug: Duvelisib, Drug: ObinutuzumabDuvelisib 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DuvelisibAlso: Copiktra, IPI-145PI3K Inhibitor | Drug | Duvelisib and Obinutuzumab, Duvelisib and Rituximab |
| RituximabAlso: Rituxan/MabThera®monoclonal antibody | Drug | Duvelisib and Rituximab |
| ObinutuzumabAlso: GAZYVA/GAZYVARO™monoclonal antibody | Drug | Duvelisib and Obinutuzumab |
Primary outcome
Number of Subjects With Dose Limiting Toxicities (DLTs) - Part 1
Time frame: 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
5 secondary outcomes
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
Overall Response Rate (ORR)
Time frame: 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
Overall Survival (OS)
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hagop Youssoufian, MD study chair
Verastem, Inc.
21 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Duvelisib, Rituximab and Obinutuzumab in people with CD20+ Follicular Lymphoma, run by SecuraBio at 21 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, France, Spain, Belgium, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Dose Limiting Toxicities (DLTs) - Part 1 (time frame: 28 days from first dose of study treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.