Status:
WITHDRAWN
Phase 2 Study of Duvelisib in Previously Treated Patients With Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma
Lead Sponsor:
SecuraBio
Conditions:
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- ≥ 18 years of age.
- Diagnosis of CLL or SLL.
- Received at least one prior anti-cancer therapy for CLL or SLL.
- Previous exposure to BTKi and meet at least one of the criteria below:
- Progressive disease (PD) while receiving or within 6 months after completing BTKi therapy.
- Discontinued a BTKi therapy due to BTKi treatment- related intolerance.
- Measurable disease with a lymph node or tumor mass \> 1.5 cm in at least one dimension.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Resolution of toxicities due to prior BTKi therapy to acceptable level.
- Willingness of male and female patients to use medically acceptable methods of birth control.
- Willing and able to participate in all required study evaluations and procedures.
Exclusion
- Richter's transformation or prolymphocytic leukemia
- Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
- Received prior transplant
- Experienced PD or serious adverse events on a prior phosphoinositide-3-kinase (PI3K) inhibitor
- Known central nervous system involvement by CLL/SLL
Key Trial Info
Start Date :
February 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03370185
Start Date
February 12 2018
End Date
March 1 2021
Last Update
February 28 2023
Active Locations (8)
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1
Arizona Oncology
Tempe, Arizona, United States, 85284
2
Genesis Cancer Center
Hot Springs, Arkansas, United States, 71913
3
Moores UC San Diego Cancer Center
La Jolla, California, United States, 92093
4
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426