A Phase 3 interventional study of Duvelisib and Placebo in Indolent Non-Hodgkin's Lymphoma, Follicular Lymphoma and Small Lymphocytic Lymphoma, sponsored by SecuraBio. Withdrawn at 7 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-17.
Sponsored by SecuraBio · Phase 3, Interventional, and Treatment
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).
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.
964 studies on the registry are indexed under Lymphoma, Follicular; 242 are open to participants now.
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Diagnosis of iNHL with one of the following histologic sub-types and grade:
Have received the following systemic treatments for iNHL:
Exclusion Criteria:
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
Duvelisib 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.
Drug: Duvelisib · Drug: Rituximab · Drug: Bendamustine
Placebo 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.
Drug: Placebo · Drug: Rituximab · Drug: Bendamustine
Duvelisib (25 mg BID) administered orally in 28-day continuous treatment cycles
Also known as: IPI-145
Matching placebo (25 mg BID) administered orally in 28-day continuous treatment cycles
IV infusion of rituximab (375 mg/m2) on Day 1 of Cycles 1-6.
Also known as: Rituxan, MabThera
IV infusion of bendamustine (90 mg/m2) on Day 1 and Day 2 of Cycles 1-6.
Also known as: Treanda, Levact
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
Complete Response (CRR)
Time frame: 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.
Overall Response Rate (ORR)
Time frame: 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.
Overall Survival (OS)
Time frame: Every 6 months for up to 5 years from date of randomization
Duration of Response (DOR)
Time frame: 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.
Safety (Treatment- emergent adverse events (TEAEs) and changes in safety laboratory values)
Time frame: Continuous from informed consent until 30 days from last dose
Pharmacokinetics (PK)
Evaluate the Duvelisib concentration in plasma sample.
Time frame: Cycle 1 and Cycle 2 (each cycle is 28 days)
Pharmacokinetics (PK)
Evaluate IPI-656 (metabolite) concentration in plasma sample.
Time frame: Cycle 1 and Cycle 2 (each cycle is 28 days)
The record gives a start of Dec 2015, a primary completion of Nov 2016 and a completion of Nov 2016. It does not say whether these dates are actual or estimated.
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This study is withdrawn, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Duvelisib