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

Primary Purpose

Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Duvelisib
Sponsored by
SecuraBio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring Leukemia, Lymphoma, Refractory, Relapse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona Oncology
  • Genesis Cancer Center
  • Moores UC San Diego Cancer Center
  • Ingalls Memorial Hospital
  • QUEST Research Institute
  • St. Vincent Frontier Cancer Center
  • Summit Medical Group
  • Medical Oncology Associates PS, WA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Duvelisib

Arm Description

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

Outcomes

Primary Outcome Measures

Overall Response Rate (ORR)

Secondary Outcome Measures

Treatment-Emergent adverse events (TEAEs) and changes in laboratory values
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
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
Disease control rate (DCR), defined as CR/CRi + PR/PRwL + stable disease (SD) ≥ 8 weeks

Full Information

First Posted
November 29, 2017
Last Updated
February 24, 2023
Sponsor
SecuraBio
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1. Study Identification

Unique Protocol Identification Number
NCT03370185
Brief Title
Phase 2 Study of Duvelisib in Previously Treated Patients With Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Reassessing corporate priorities.
Study Start Date
February 12, 2018 (Actual)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SecuraBio

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Keywords
Leukemia, Lymphoma, Refractory, Relapse

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Duvelisib
Arm Type
Experimental
Arm Description
Duvelisib 25 mg orally (PO) twice daily (BID) continuously in 28-day cycles
Intervention Type
Drug
Intervention Name(s)
Duvelisib
Intervention Description
Duvelisib 25 mg orally (PO) twice daily (BID) continuously in 28-day cycles
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Time Frame
From start of treatment to first documented response, 2 cycles (58 days)
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
Disease control rate (DCR), defined as CR/CRi + PR/PRwL + stable disease (SD) ≥ 8 weeks
Time Frame
Greater than or equal to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Arizona Oncology
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85284
Country
United States
Facility Name
Genesis Cancer Center
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Moores UC San Diego Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Ingalls Memorial Hospital
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
QUEST Research Institute
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
St. Vincent Frontier Cancer Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Summit Medical Group
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07932
Country
United States
Facility Name
Medical Oncology Associates PS, WA
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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