Clinical trial NCT03370185: Phase 2 Study of Duvelisib in Previously Treated Patients With Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma
Official title: 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)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Keywords: Leukemia
Lymphoma
Refractory
Relapse
Lead sponsor: SecuraBio
Sponsor class: INDUSTRY
First posted: 2017-12-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: From start of treatment to first documented response, 2 cycles (58 days)
Secondary outcomes:
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: 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
timeFrame: Time from the first documentation of response to first documentation of progressive disease or death due to any cause, 6 months
measure: 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
timeFrame: Time from start of treatment to first documentation of progression or date of death from any cause, whichever came first, 4 months
measure: Disease control rate (DCR), defined as CR/CRi + PR/PRwL + stable disease (SD) ≥ 8 weeks
timeFrame: Greater than or equal to 8 weeks
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Arizona Oncology
state: Arizona
city: Hot Springs
country: United States
facility: Genesis Cancer Center
state: Arkansas
city: La Jolla
country: United States
facility: Moores UC San Diego Cancer Center
state: California
city: Harvey
country: United States
facility: Ingalls Memorial Hospital
state: Illinois
city: Royal Oak
country: United States
facility: QUEST Research Institute
state: Michigan
city: Billings
country: United States
facility: St. Vincent Frontier Cancer Center
state: Montana
city: Morristown
country: United States
facility: Summit Medical Group
state: New Jersey
city: Spokane
country: United States
facility: Medical Oncology Associates PS, WA
state: Washington
Study officials:
References: