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

February 24, 2023 updated by: SecuraBio

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)

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tempe, Arizona, United States, 85284
        • Arizona Oncology
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Genesis Cancer Center
    • California
      • La Jolla, California, United States, 92093
        • Moores UC San Diego Cancer Center
    • Illinois
      • Harvey, Illinois, United States, 60426
        • Ingalls Memorial Hospital
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Quest Research Institute
    • Montana
      • Billings, Montana, United States, 59102
        • St. Vincent Frontier Cancer Center
    • New Jersey
      • Morristown, New Jersey, United States, 07932
        • Summit Medical Group
    • Washington
      • Spokane, Washington, United States, 99208
        • Medical Oncology Associates PS, WA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Response Rate (ORR)
Time Frame: From start of treatment to first documented response, 2 cycles (58 days)
From start of treatment to first documented response, 2 cycles (58 days)

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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 Frame: Time from the first documentation of response to first documentation of progressive disease or death due to any cause, 6 months
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 Frame: Time from start of treatment to first documentation of progression or date of death from any cause, whichever came first, 4 months
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
Time Frame: Greater than or equal to 8 weeks
Greater than or equal to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SecuraBio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2018

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

March 1, 2021

Study Registration Dates

First Submitted

November 29, 2017

First Submitted That Met QC Criteria

December 5, 2017

First Posted (Actual)

December 12, 2017

Study Record Updates

Last Update Posted (Estimate)

February 28, 2023

Last Update Submitted That Met QC Criteria

February 24, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VS-0145-224

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Lymphocytic Leukemia

Clinical Trials on Duvelisib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe