Phase 2
N=129
A Study of Duvelisib in Participants With Refractory Indolent Non-Hodgkin Lymphoma
Indolent Non-Hodgkin Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT01882803 ↗Enrolled (actual)
129
Serious AEs
64.3%
Results posted
Nov 2018
Primary outcome: Primary: Overall Response Rate (ORR) — 59.7 percentage of participants — p=<=0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Duvelisib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- SecuraBio
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR) |
59.7 | <=0.0001 sig |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
128 | — |
| SECONDARY Duration of Response (DOR) |
10.16 | — |
| SECONDARY Progression-free Survival (PFS) |
9.57 | — |
| SECONDARY Overall Survival (OS) |
28.96 | — |
| SECONDARY Plasma Concentration of Duvelisib and IPI-656 |
414; 648; 1175; 641; 852; 714 | — |
| SECONDARY Time to Response (TTR) |
1.87 | — |
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 radioimmunotherapy (RIT).
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT01882803). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.