Clinical trial · Interventional
Phase 2 Study of Duvelisib in Previously Treated Patients With Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma
A Phase 2 Study of Duvelisib Efficacy and Safety in Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Previously Treated With a Bruton's Tyrosine Kinase Inhibitor (BTKi)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Reassessing corporate priorities.
Summary
Brief summary (as posted)
This is a multi-center, single-arm, open-label, Phase 2 study of duvelisib, an orally bioavailable dual inhibitor of PI3K-δ,γ, in patients with CLL/SLL who have previously been treated with ibrutinib or another Bruton's Tyrosine Kinase Inhibitor (BTKi) and relapsed or were refractory to such therapy or discontinued such therapy due to toxicity.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Small Lymphocytic Lymphoma | Small Lymphocytic 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
- Duvelisib 25 mg orally (PO) twice daily (BID) continuously in 28-day cycles
- interventionNames
- Drug: Duvelisib
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
- timeFrame
- From start of treatment to first documented response, 2 cycles (58 days)
Secondary outcomes (4)
- measure
- Treatment-Emergent adverse events (TEAEs) and changes in laboratory values
- timeFrame
- From start of treatment to end of treatment plus 30 days; 7 months
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. ≥ 18 years of age. 2. Diagnosis of CLL or SLL. 3. Received at least one prior anti-cancer therapy for CLL or SLL. 4. Previous exposure to BTKi and meet at least one of the criteria below: 1. Progressive disease (PD) while receiving or within 6 months after completing BTKi therapy. 2. Discontinued a BTKi therapy due to BTKi treatment- related intolerance. 5. Measurable disease with a lymph node or tumor mass \> 1.5 cm in at least one dimension. 6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. 7. Resolution of toxicities due to prior BTKi therapy to acceptable level. 8. Willingness of male and female patients to use medically acceptable methods of birth control. 9. Willing and able to participate in all required study evaluations and procedures. Exclusion Criteria: 1. Richter's transformation or prolymphocytic leukemia 2. Uncontrolled autoimmune hemolytic anemia or thrombocytopenia 3. Received prior transplant 4. Experienced PD or serious adverse events on a prior phosphoinositide-3-kinase (PI3K) inhibitor 5. Known central nervous system involvement by CLL/SLL
References
Publications (0)
Data not yet available