BRIO: Phase 2 Study of Duvelisib in Previously Treated Patients With Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma

Sponsor

SecuraBio (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT03370185

Collaborator

(none)

Enrollment

Locations

Arm

36.6

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma	Drug: Duvelisib	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Feb 12, 2018

Anticipated Primary Completion Date :

Jun 1, 2020

Anticipated Study Completion Date :

Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Duvelisib 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

Arm

Intervention/Treatment

Experimental: Duvelisib

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

Outcome Measures

Primary Outcome Measures

Overall Response Rate (ORR) [From start of treatment to first documented response, 2 cycles (58 days)]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

≥ 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 Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	QUEST Research Institute	Royal Oak	Michigan	United States	48073
6	St. Vincent Frontier Cancer Center	Billings	Montana	United States	59102
7	Summit Medical Group	Morristown	New Jersey	United States	07932
8	Medical Oncology Associates PS, WA	Spokane	Washington	United States	99208