Clinical trial · Interventional
A Study of Duvelisib in Participants With Refractory Indolent Non-Hodgkin Lymphoma
A Phase 2 Study of Duvelisib in Subjects With Refractory Indolent Non-Hodgkin Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Indolent Non-Hodgkin Lymphoma | Indolent Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Duvelisib | Drug | Duvelisib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Duvelisib
- interventionNames
- Drug: Duvelisib
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
- timeFrame
- Every 8-16 weeks while on treatment with duvelisib for up to 72 months
- description
- 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.
Secondary outcomes (6)
- measure
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)
- timeFrame
- Every 2-8 weeks for up to 73 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDFlinn 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. PMID 30742566