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Indolent Non-Hodgkin's LymphomaPhase 3NCT02576275

A Study of Duvelisib in Combination With Rituximab and Bendamustine vs Placebo in Combination With Rituximab and Bendamustine in Subjects With Previously-Treated Indolent Non-Hodgkin Lymphoma (BRAVURA)

A Phase 3 study testing Duvelisib, Rituximab and Bendamustine in people with Indolent Non-Hodgkin's Lymphoma and Follicular Lymphoma, run by SecuraBio at 7 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study will evaluate the efficacy and safety of duvelisib in combination with bendamustine and rituximab (DBR) vs placebo in combination with bendamustine and rituximab (PBR) in subjects with previously-treated indolent non-Hodgkin lymphoma (iNHL). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Duvelisib, Rituximab and Bendamustine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
7 sitesUnited States
Study dates
Dec 2015to Nov 2016
Phase
Phase 3
Are there results?
None posted in the registry

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Diagnosis of iNHL with one of the following histologic sub-types and grade:
  • Follicular lymphoma (FL)Grade 1, 2, or 3a
  • Small lymphocytic lymphoma (SLL)
  • Marginal zone lymphoma (MZL)( splenic, nodal, or extranodal)
  • Have received the following systemic treatments for iNHL:
  • an anti-CD20 antibody; and
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  • chemotherapy
  • At least 1 measurable disease lesion > 1.5 cm in at least one dimension by computed tomography (CT)/CT-PET or magnetic resonance imaging (MRI)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 (corresponds to Karnofsky Performance Status [(KPS) ≥60%])

Who cannot join

  • Clinical evidence of transformation to a more aggressive subtype of lymphoma or grade 3B FL
  • Refractory to bendamustine + rituximab therapy or single-agent bendamustine 120 mg/m2, with refractory defined as:
  • Progression of disease while receiving or within 6 months of completing treatment
  • Severe allergic or anaphylactic reaction to any monoclonal antibody therapy, murine protein, or known hypersensitivity to any of the study drugs
  • Received prior allogeneic transplant
  • Received prior treatment with a phosphoinositide-3-kinase (PI3K) inhibitor
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  • Infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
  • History of tuberculosis treatment within the two years prior to randomization
  • History of chronic liver disease, veno-occlusive disease, or alcohol abuse
  • Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine) or systemic steroids > 20 mg of prednisone (or equivalent) daily (QD)
  • Ongoing treatment for systemic bacterial, fungal, or viral infection at screening
  • Unable to receive prophylactic treatment for pneumocystis, herpes simplex virus (HSV), or herpes zoster (VZV) at screening
  • Concurrent active malignancy other than adequately treated non-melanoma skin cancer or lentigo maligna without evidence of invasive disease or adequately treated cervical carcinoma in situ without evidence of disease
  • History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or a pacemaker within the last 6 months prior to screening
  • History of progressive multifocal leukoencephalopathy

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Study site

    Cookeville, Tennessee, 38501

  • Study site

    East Setauket, New York, 11733-3456

  • Study site

    Knoxville, Tennessee, 37909

  • Study site

    Plainville, Connecticut, 06062

  • Study site

    Plantation, Florida, 33322

  • Study site

    Spokane, Washington, 99208

  • Study site

    Thomasville, Georgia, 31792

Other trials in United States

About this study

Official title: A Phase 3, Randomized, Double-blind Study of Duvelisib Administered in Combination With Rituximab and Bendamustine vs Placebo Administered in Combination With Rituximab and Bendamustine in Subjects With Previously-Treated Indolent Non-Hodgkin Lymphoma

This study will evaluate the efficacy and safety of duvelisib in combination with bendamustine and rituximab (DBR) vs placebo in combination with bendamustine and rituximab (PBR) in subjects with previously-treated indolent non-Hodgkin lymphoma (iNHL).

Read the detailed description

Study IPI-145-22 is an international, multicenter, randomized, double-blind, placebo-controlled, two-arm Phase 3 study designed to evaluate efficacy and safety of DBR vs PBR in subjects with previously-treated iNHL (including follicular lymphoma [FL], small lymphocytic lymphoma [SLL] and marginal zone lymphoma [MZL]).

Approximately 600 subjects will receive 25 mg of duvelisib or placebo, orally BID for 28 day continuous cycles, in combination with 375 mg/m2 of rituximab given on Day 1 of Cycles 1-6 and 90 mg/m2 of bendamustine given on Day 1 and Day 2 of Cycles 1-6. Subjects will receive duvelisib until disease progression or unacceptable toxicity.

Being tested
Duvelisib, Placebo, Rituximab, Bendamustine
Keywords
Phase 3, iNHL, Follicular Lymphoma, FL, PI3K, Small Lymphocytic Lymphoma, SLL, Marginal Zone Lymphoma, MZL
Medical subject headings
Lymphoma, Follicular, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, B-Cell, Marginal Zone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DuvelisibDrug

    Also called IPI-145

    Duvelisib (25 mg BID) administered orally in 28-day continuous treatment cycles

  • PlaceboDrug

    Matching placebo (25 mg BID) administered orally in 28-day continuous treatment cycles

  • RituximabDrug

    Also called Rituxan, MabThera

    IV infusion of rituximab (375 mg/m2) on Day 1 of Cycles 1-6.

  • BendamustineDrug

    Also called Treanda, Levact

    IV infusion of bendamustine (90 mg/m2) on Day 1 and Day 2 of Cycles 1-6.

Study groups in NCT02576275
Study groupRoleWhat they receive
Duvelisib + Rituximab + BendamustineExperimentalDuvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules. Bendamustine is administered as an intravenous (IV) infusion and is supplied for injection in single-use vials at two strengths, 25 mg and 100 mg. Rituximab is administered as an IV infusion and is supplied in single-use vials at two strengths, 100 mg and 500 mg.
Receives: Drug: Duvelisib; Drug: Rituximab; Drug: Bendamustine
Placebo + Rituximab + BendamustinePlacebo comparatorPlacebo is administered orally and supplied as formulated capsules to match the active 5 mg and 25 mg capsules of duvelisib. Bendamustine is administered as an IV infusion and is supplied for injection in single-use vials at two strengths, 25 mg and 100 mg. Rituximab is administered as an IV infusion and is supplied in single-use vials at two strengths, 100 mg and 500 mg.
Receives: Drug: Placebo; Drug: Rituximab; Drug: Bendamustine

What is being measured

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

  1. Progression-Free Survival (PFS)

    Measured: From date of enrollment until the date of first documentation of progression or date of death from any cause, whatever came first, assessed up to 78 months

Secondary outcomes (7)

  1. Complete Response (CRR)

    Measured: Every 3-6 Cycles (each cycle is 28 days) from date of randomization, until date of first documented progression. Subjects will be evaluated for progression through the primary analysis of the study or 5 years from randomization, whichever is later.

  2. Overall Response Rate (ORR)

    Measured: Every 3-6 Cycles (each cycle is 28 days) from date of randomization, until date of first documented progression. Subjects will be evaluated for progression through the primary analysis of the study or 5 years from randomization, whichever is later.

  3. Overall Survival (OS)

    Measured: Every 6 months for up to 5 years from date of randomization

  4. Duration of Response (DOR)

    Measured: Every 3-6 Cycles (each cycle is 28 days) from date of randomization, until date of first documented progression. Subjects will be evaluated for progression through the primary analysis of the study or 5 years from randomization, whichever is later.

  5. Safety (Treatment- emergent adverse events (TEAEs) and changes in safety laboratory values)

    Measured: Continuous from informed consent until 30 days from last dose

  6. Pharmacokinetics (PK)

    Evaluate the Duvelisib concentration in plasma sample.

    Measured: Cycle 1 and Cycle 2 (each cycle is 28 days)

  7. Pharmacokinetics (PK)

    Evaluate IPI-656 (metabolite) concentration in plasma sample.

    Measured: Cycle 1 and Cycle 2 (each cycle is 28 days)

Timeline

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

  1. First posted15 Oct 2015 (estimated)
  2. Study startDec 2015
  3. Primary completionNov 2016
  4. Study completionNov 2016

Why it stopped: The scope of the program has been reduced to focus resources on studies which can potentially enable the registration of duvelisib.

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02576275
Sponsor's protocol ID
IPI-145-22
Status last verified
Mar 2021
First submitted
7 Oct 2015
Last updated
17 Mar 2021
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Duvelisib, Rituximab and Bendamustine in people with Indolent Non-Hodgkin's Lymphoma and Follicular Lymphoma, run by SecuraBio at 7 sites in United States.

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 9 inclusion and 15 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: withdrawn, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Progression-Free Survival (PFS) (time frame: From date of enrollment until the date of first documentation of progression or date of death from any cause, whatever came first, assessed up to 78 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 NCT02576275.

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 17 Mar 2021.

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