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

Chronic Lymphocytic Leukemia Clinical Trial

— BRIO  

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03370185
• Other study ID #: VS-0145-224
• Status: Withdrawn
• Phase: Phase 2
• Start date: February 12, 2018
• Est. completion date: March 2021

Study information

• Verified date: February 2023
• Source: SecuraBio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2021
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma
• Small Lymphocytic Lymphoma

Intervention

Drug:
• Duvelisib
Duvelisib 25 mg orally (PO) twice daily (BID) continuously in 28-day cycles

Locations

Country	Name	City	State
United States	St. Vincent Frontier Cancer Center	Billings	Montana
United States	Ingalls Memorial Hospital	Harvey	Illinois
United States	Genesis Cancer Center	Hot Springs	Arkansas
United States	Moores UC San Diego Cancer Center	La Jolla	California
United States	Summit Medical Group	Morristown	New Jersey
United States	QUEST Research Institute	Royal Oak	Michigan
United States	Medical Oncology Associates PS, WA	Spokane	Washington
United States	Arizona Oncology	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
SecuraBio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR)		From start of treatment to first documented response, 2 cycles (58 days)
Secondary	Treatment-Emergent adverse events (TEAEs) and changes in laboratory values		From start of treatment to end of treatment plus 30 days; 7 months
Secondary	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
Secondary	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
Secondary	Disease control rate (DCR), defined as CR/CRi + PR/PRwL + stable disease (SD) = 8 weeks		Greater than or equal to 8 weeks