Clinical trial · Interventional
A Safety and Efficacy Study of Duvelisib in Relapsed/Refractory Follicular Lymphoma
A Phase 2, Single Arm, Open Label, Multi-center Clinical Study of Dual PI3K-δ,γ Inhibitor Duvelisib in Patients With Relapsed/Refractory Follicular Lymphoma
NCT04707079CI-TRIAL-00049413unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 is a phase 2 clinical trial to evaluate the safety and efficacy of duvelisib as a monotherapy in subjects diagnosed with follicular lymphoma (FL) that is relapsed or refractory 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 |
|---|---|---|---|
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Duvelisib | Drug | Duvelisib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Duvelisib
- description
- Eligible subjects will be given duvelisib (15mg, 25mg), orally at a dose of 25 mg BID during each 28-day treatment cycle, for up to 12 cycles.
- interventionNames
- Drug: Duvelisib
Primary outcomes (1)
- measure
- Overall Response Rate (ORR),
- timeFrame
- Within 7 days prior to initiating the next cycle of study treatment (i.e. Day -7 to Day 1) of Cycles 3, 5, 7, 9 (each cycle is 28 days) and at every fourth cycle thereafter (Cycle 13, 17, 21, etc.) up to the end of treatment, an average of 8 months.
- description
- Defined as the best response of complete response/remission (CR) or partial response/remission (PR), according to the Cheson 2007 Criteria by Independent Review Committee (IRC)
Secondary outcomes (10)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subjects must have been fully informed and signed informed consent form. 2. Subjects must be adults (\>/=18 years), male or female. 3. Subjects who have been defined as FL by histologic or cytologic diagnosis, and must have relapsed or been refractory (at least two prior regimens for FL). 4. Measurable disease with a lymph node or tumor mass ≥1.5 cm in at least one dimension by CT, PET/CT or MRI according to Lugano 2014 criteria. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 6. Adequate renal and hepatic function. 7. Women of childbearing potential must have a negative serum or urine β human chorionic gonadotropin (βhCG) pregnancy test. 8. Willingness of male and female subjects who are not surgically sterile or postmenopausal to use medically acceptable methods of birth control for the duration of the study, including 30 days after the last dose of duvelisib. Exclusion Criteria: 1. Grade 3B FL and/or clinical evidence of transformation to a more aggressive subtype of lymphoma. 2. Known hypersensitivity to the study drug duvelisib or excipients. 3. Previous treatment with a PI3K inhibitor or BTK inhibitor. 4. Prior history of allogeneic hematopoietic stem cell transplant (HSCT). 5. Prior chemotherapy, cancer immunosuppressive therapy, radiotherapy or other investigational agents within 4 weeks before the first dose of study drug. 6. Symptomatic central nervous system (CNS) Lymphoma. 7. Ongoing systemic bacterial, fungal, or viral infections at the time of initiation of study treatment. 8. Human immunodeficiency virus (HIV) infection. 9. Active cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection. 10. Hepatitis B or hepatitis C Infection. 11. History of stroke, unstable angina, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months prior to first dose of study drug. 12. Female subjects who are pregnant or breastfeeding.
References
Publications (0)
Data not yet available
No reference posted for this study.