Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Conditions
Keywords
Leukemia, Lymphoma, Refractory, Relapse
Brief summary
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.
Interventions
DRUGDuvelisib
Duvelisib 25 mg orally (PO) twice daily (BID) continuously in 28-day cycles
Sponsors
SecuraBio
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate (ORR) | From start of treatment to first documented response, 2 cycles (58 days) |
Secondary
| Measure | Time frame |
|---|---|
| Treatment-Emergent adverse events (TEAEs) and changes in laboratory values | From start of treatment to end of treatment plus 30 days; 7 months |
| Duration of response (DOR), defined as the time from the first documentation of response to the first documentation of PD or death due to any cause | Time from the first documentation of response to first documentation of progressive disease or death due to any cause, 6 months |
| Progression-free survival (PFS), defined as the time from the first dose of study treatment to the first documentation of PD or death from any cause | Time from start of treatment to first documentation of progression or date of death from any cause, whichever came first, 4 months |
| Disease control rate (DCR), defined as CR/CRi + PR/PRwL + stable disease (SD) ≥ 8 weeks | Greater than or equal to 8 weeks |
Countries
United States
Outcome results
None listed