A Phase 2 interventional study of Duvelisib in Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by SecuraBio. Withdrawn at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-28.
Sponsored by SecuraBio · Phase 2, Interventional, and Treatment
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.
1,648 studies on the registry are indexed under Leukemia, Lymphocytic, Chronic, B-Cell; 245 are open to participants now.
Browse Leukemia, Lymphocytic, Chronic, B-Cell studies →SecuraBio is the lead sponsor of 25 studies on the registry; 2 are open to participants now.
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Previous exposure to BTKi and meet at least one of the criteria below:
Exclusion Criteria:
Duvelisib 25 mg orally (PO) twice daily (BID) continuously in 28-day cycles
Drug: Duvelisib
Duvelisib 25 mg orally (PO) twice daily (BID) continuously in 28-day cycles
Overall Response Rate (ORR)
Time frame: From start of treatment to first documented response, 2 cycles (58 days)
Treatment-Emergent adverse events (TEAEs) and changes in laboratory values
Time frame: 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 frame: 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 frame: 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
Time frame: Greater than or equal to 8 weeks
Plan to share: No
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This study is withdrawn, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Duvelisib
Leukemia, Lymphocytic, Chronic, B-Cell →