Chronic Lymphocytic LeukemiaPhase 2BRIONCT03370185
Phase 2 Study of Duvelisib in Previously Treated Patients With Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma
A Phase 2 study testing Duvelisib in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by SecuraBio at 8 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
- What is being tested?
- Duvelisib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 8 sitesUnited States
- Study dates
- 12 Feb 2018to Mar 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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.
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- 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.
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
St. Vincent Frontier Cancer Center
Billings, Montana, 59102
Ingalls Memorial Hospital
Harvey, Illinois, 60426
Genesis Cancer Center
Hot Springs, Arkansas, 71913
Moores UC San Diego Cancer Center
La Jolla, California, 92093
Summit Medical Group
Morristown, New Jersey, 07932
QUEST Research Institute
Royal Oak, Michigan, 48073
Medical Oncology Associates PS, WA
Spokane, Washington, 99208
Arizona Oncology
Tempe, Arizona, 85284
About this study
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)
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.
- Being tested
- Duvelisib
- Keywords
- Leukemia, Lymphoma, Refractory, Relapse
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Lymphoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuvelisibDrug
Duvelisib 25 mg orally (PO) twice daily (BID) continuously in 28-day cycles
| Study group | Role | What they receive |
|---|---|---|
| Duvelisib | Experimental | Duvelisib 25 mg orally (PO) twice daily (BID) continuously in 28-day cycles Receives: Drug: Duvelisib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
Measured: From start of treatment to first documented response, 2 cycles (58 days)
Secondary outcomes (4)
Treatment-Emergent adverse events (TEAEs) and changes in laboratory values
Measured: 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
Measured: 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
Measured: 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
Measured: Greater than or equal to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start12 Feb 2018
- Primary completionJun 2020 (estimated)
- Study completionMar 2021 (estimated)
Why it stopped: Reassessing corporate priorities.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- SecuraBio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03370185
- Sponsor's protocol ID
- VS-0145-224
- Acronym
- BRIO
- Status last verified
- Feb 2023
- First submitted
- 29 Nov 2017
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03370185
- Acronym / sponsor ID
- BRIO / VS-0145-224
- Keywords
- Leukemia, Lymphoma, Refractory, Relapse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Reassessing corporate priorities.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- SecuraBioIndustry (pharma, biotech, devices)
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 12 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Duvelisib | Experimental | Drug: DuvelisibDuvelisib 25 mg orally (PO) twice daily (BID) continuously in 28-day cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- ≥ 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:
- Measurable disease with a lymph node or tumor mass > 1.5 cm in at least one dimension.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DuvelisibDuvelisib 25 mg orally (PO) twice daily (BID) continuously in 28-day cycles | Drug | Duvelisib |
Primary outcome
Overall Response Rate (ORR)
Time frame: From start of treatment to first documented response, 2 cycles (58 days)
4 secondary outcomes
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
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
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
Disease control rate (DCR), defined as CR/CRi + PR/PRwL + stable disease (SD) ≥ 8 weeks
Time frame: Greater than or equal to 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Duvelisib in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by SecuraBio at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: From start of treatment to first documented response, 2 cycles (58 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023.