AzTrials
AzTrials

Indolent Non-Hodgkin LymphomaPhase 2DYNAMONCT01882803

A Study of Duvelisib in Participants With Refractory Indolent Non-Hodgkin Lymphoma

A Phase 2 study testing Duvelisib in people with Indolent Non-Hodgkin Lymphoma, run by SecuraBio at 69 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This was a Phase 2 clinical trial to evaluate the safety and efficacy of duvelisib as a monotherapy in participants with indolent non-Hodgkin lymphoma (iNHL) (follicular lymphoma [FL], marginal zone lymphoma, or small lymphocytic lymphoma) that was refractory to rituximab and to either chemotherapy or… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Indolent Non-Hodgkin Lymphoma
What is being tested?
Duvelisib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
129 participants
Where
69 sitesin 12 countries
Study dates
17 Jun 2013to 18 Nov 2020
Phase
Phase 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

  • Participants who had been diagnosed with iNHL that had progressed.
  • Participants must have exhibited lack of CR or progressive disease (PR) or progression within 6 months after the last dose of a chemotherapy induction regimen or RIT.
  • Participants must have had rituximab-refractory disease, defined as lack of CR or PR or PD within 6 months of last dose.
  • Measurable disease with a lymph node or tumor mass ≥1.5 centimeters in at least one dimension by computed tomography (CT), positron emission tomography/CT or magnetic resonance imaging.
  • Adequate renal and hepatic function.

Who cannot join

  • Candidate for potentially curative therapies in the opinion of the investigator.
  • Previous treatment with a PI3K inhibitor or Bruton's tyrosine kinase inhibitor.
  • Prior history of allogeneic hematopoietic stem cell transplant.
  • Prior chemotherapy, cancer immunosuppressive therapy, or other investigational agents within 4 weeks before first dose of study drug.
  • Grade 3B FL and/or clinical evidence of transformation to a more aggressive subtype of lymphoma.
  • Symptomatic central nervous system NHL.
Show all 9Show fewer
  • Ongoing systemic bacterial, fungal, or viral infections at the time of initiation of study treatment.
  • Prior, current, or chronic hepatitis B or hepatitis C infection, positive result for hepatitis C virus antibodies, hepatitis B surface antigen, or hepatitis B core antibodies.
  • History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months prior to first dose of study drug.

Trial locations and contacts

69 sites in 12 countries.

69 sites in 12 countries

United States24 sites

  • Study site

    Atlanta, Georgia, 30322

  • Study site

    Baltimore, Maryland, 21204

  • Study site

    Baltimore, Maryland, 21229

  • Study site

    Boston, Massachusetts, 02215

  • Study site

    Canton, Ohio, 44718

  • Study site

    Chicago, Illinois, 60637

  • Study site

    Dallas, Texas, 75246

  • Study site

    Denver, Colorado, 80218

  • Study site

    Fort Myers, Florida, 39916

  • Study site

    Howell Township, New Jersey, 07731

  • Study site

    Lawton, Oklahoma, 73505

  • Study site

    Los Angeles, California, 90095-6984

  • Study site

    Louisville, Kentucky, 40207

  • Study site

    Lynchburg, Virginia, 24501

  • Study site

    Morristown, New Jersey, 07962

  • Study site

    Nashville, Tennessee, 37203

  • Study site

    New York, New York, 10021

  • Study site

    Oklahoma City, Oklahoma, 73104

  • Study site

    Philadelphia, Pennsylvania, 01911

  • Study site

    Rockville Centre, New York, 11510

  • Study site

    St Louis, Missouri, 63110

  • Study site

    St. Petersburg, Florida, 33705

  • Study site

    Tallahassee, Florida, 32308

  • Study site

    Whittier, California, 90603

Other trials in United States

Italy12 sites

  • Study site

    Bologna, 40138

  • Study site

    Brescia, 25123

  • Study site

    Busto Arsizio, 21052

  • Study site

    Genova, 16132

  • Study site

    Meldola, 47014

  • Study site

    Milan, 20162

  • Study site

    Modena, 41124

  • Study site

    Orbassano, 10043

  • Study site

    Parma, 43100

  • Study site

    Ravenna, 48121

  • Study site

    Rimini, 47923

  • Study site

    Varese, 21100

Other trials in Italy

United Kingdom6 sites

  • Study site

    Cardiff, CF 14 4XW

  • Study site

    Chelsea

  • Study site

    Liverpool, L7 8XP

  • Study site

    London, NW1 2PG

  • Study site

    London, W1G 6AD

  • Study site

    Sutton, SM2 5PT

Other trials in United Kingdom

France5 sites

  • Study site

    Angers, 49933

  • Study site

    Bordeaux, 33076

  • Study site

    Clermont-Ferrand, 63000

  • Study site

    Marseille, 13005

  • Study site

    Pierre-Bénite, 69495

Other trials in France

Belarus4 sites

  • Study site

    Brest, 224027

  • Study site

    Lyasny, Minsk Oblast, 223040

  • Study site

    Minsk, 220013

  • Study site

    Vitebsk, 210603

Other trials in Belarus

Bulgaria4 sites

  • Study site

    Sofia, 1233

  • Study site

    Sofia, 1407

  • Study site

    Sofia, 1431

  • Study site

    Sofia, 1756

Other trials in Bulgaria

Canada3 sites

  • Study site

    Gatineau, Quebec, J8P7H2

  • Study site

    Montreal, Quebec, H3T 1E2

  • Study site

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Hungary3 sites

  • Study site

    Budapest, 1083

  • Study site

    Budapest, 1122

  • Study site

    Debrecen, 4032

Other trials in Hungary

Spain3 sites

  • Study site

    Barcelona, 08036

  • Study site

    Madrid, 28222

  • Study site

    Salamanca, 37007

Other trials in Spain

Belgium2 sites

  • Study site

    Ghent, 9000

  • Study site

    Kortrijk, 8500

Other trials in Belgium

Czechia2 sites

  • Study site

    Brno, 625-00

  • Study site

    Ostrava-Poruba, 708-52

Other trials in Czechia

Georgia1 site

  • Study site

    Tbilisi, 0186

Other trials in Georgia

About this study

Official title: A Phase 2 Study of Duvelisib in Subjects With Refractory Indolent Non-Hodgkin Lymphoma

This was a Phase 2 clinical trial to evaluate the safety and efficacy of duvelisib as a monotherapy in participants with indolent non-Hodgkin lymphoma (iNHL) (follicular lymphoma [FL], marginal zone lymphoma, or small lymphocytic lymphoma) that was refractory to rituximab and to either chemotherapy or radioimmunotherapy (RIT).

Read the detailed description

This was an open-label, single-arm safety and efficacy study of duvelisib administered orally to participants who had been diagnosed with iNHL whose disease was refractory to rituximab and to either chemotherapy or RIT.

Approximately 120 participants received 25 milligrams of duvelisib twice daily over the course of 28-day treatment cycles for up to 13 cycles.

After completing 13 treatment cycles of duvelisib, participants continued to receive additional cycles of duvelisib until disease progression or unacceptable toxicity. However, to receive additional cycles of duvelisib beyond 13 cycles, participants must have had evidence of response (complete response [CR] or partial response [PR]) or stable disease according to the International Working Group criteria by the end of Cycle 13.

Being tested
Duvelisib
Keywords
PI3K Inhibitor

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

    Phosphoinositide-3-kinase (PI3K) inhibitor

Study groups in NCT01882803
Study groupRoleWhat they receive
DuvelisibExperimentalNot described
Receives: Drug: Duvelisib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate (ORR)

    ORR, defined as the total percentage of participants who had a best overall response of either complete response (CR) or partial response (PR), was evaluated locally (investigator's assessment) according to the revised IWG Response Criteria for Malignant Lymphoma. ORR is reported with a 2-sided 95% exact confidence interval.

    Measured: Every 8-16 weeks while on treatment with duvelisib for up to 72 months

Secondary outcomes (6)

  1. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    An adverse event was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A TEAE was defined as any adverse event that emerged or worsened in the period from the first dose of study treatment to 30 days after the last dose of study treatment. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

    Measured: Every 2-8 weeks for up to 73 months

  2. Duration of Response (DOR)

    DOR, defined as the time from the first documentation of response to either progressive disease (PD) or death due to any cause, was evaluated locally (investigator's assessment) according to the revised IWG Response Criteria for Malignant Lymphoma.

    Measured: Every 8-16 weeks for up to 72 months

  3. Progression-free Survival (PFS)

    PFS, defined as the time from the first dose of study treatment to the first documentation of either Investigator-assessed PD or death resulting from any cause, was evaluated locally (investigator's assessment) according to the revised IWG Response Criteria for Malignant Lymphoma.

    Measured: Every 8-16 weeks for up to 72 months

  4. Overall Survival (OS)

    OS, defined as the time from the first dose of study treatment to the date of death, was evaluated locally (investigator's assessment) according to the revised IWG Response Criteria for Malignant Lymphoma.

    Measured: Every 16 weeks for up to 72 months

  5. Plasma Concentration of Duvelisib and IPI-656

    The serum concentration of duvelisib and its main metabolite, IPI-656, are reported for Day 15 of Cycle 1 (C1D15) and Day 1 of Cycle 2 (C2D1) and Day 1 of Cycle 3 (C3D1). Results are reported in nanograms/milliliter (ng/mL).

    Measured: Every 4 weeks for 12 weeks (C1D15: predose, 1 and 4 hours post dose; C2D1 and C3D1: anytime during study visit)

  6. Time to Response (TTR)

    TTR, defined as the time from the first dose of study treatment to the first documentation of response, was evaluated by an independent, third-party panel of radiologists and oncologists (Independent Review Committee [IRC]) according to the revised IWG Response Criteria for Malignant Lymphoma.

    Measured: First dose to first documentation of complete or partial response (up to 6 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2013 (estimated)
  2. Study start17 Jun 2013
  3. Primary completion18 Nov 2020
  4. Study completion18 Nov 2020

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
129 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01882803
Sponsor's protocol ID
IPI-145-06
Other IDs
2013-004008-20
Acronym
DYNAMO
Status last verified
Sep 2023
First submitted
31 May 2013
Last updated
7 Sep 2023
Data monitoring committee
Yes

Publications

  • Flinn IW, Miller CB, Ardeshna KM, Tetreault S, Assouline SE, Mayer J, Merli M, Lunin SD, Pettitt AR, Nagy Z, Tournilhac O, Abou-Nassar KE, Crump M, Jacobsen ED, de Vos S, Kelly VM, Shi W, Steelman L, Le N, Weaver DT, Lustgarten S, Wagner-Johnston ND, Zinzani PL. DYNAMO: A Phase II Study of Duvelisib (IPI-145) in Patients With Refractory Indolent Non-Hodgkin Lymphoma. J Clin Oncol. 2019 Apr 10;37(11):912-922. doi: 10.1200/JCO.18.00915. Epub 2019 Feb 11.

    PubMed 30742566

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Duvelisib in people with Indolent Non-Hodgkin Lymphoma, run by SecuraBio at 69 sites in 12 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 7 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 69 sites in United States, Italy, United Kingdom, France, Belarus and 7 more countries. 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 phase mean?

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 20 Nov 2018). 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?

Overall Response Rate (ORR) (time frame: Every 8-16 weeks while on treatment with duvelisib for up to 72 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01882803, which also lists 1 linked publication.

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 7 Sep 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in