Lymphocytic Leukemia, ChronicPhase 1NCT02292225
Duvelisib With Obinutuzumab in Patients With CLL/SLL Previously Treated With a BTKi (SYNCHRONY)
A Phase 1 study testing IPI-145 (duvelisib) and Obinutuzumab in people with Lymphocytic Leukemia, Chronic and Lymphoma, Small Lymphocytic, run by SecuraBio at 7 sites in 2 countries.
Trial summary
To evaluate the safety, pharmacokinetics, and pharmacodynamics of Duvelisib (IPI-145) in combination with obinutuzumab in patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma previously treated with a BTKi. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphocytic Leukemia, Chronic, Lymphoma, Small Lymphocytic
- What is being tested?
- IPI-145 (duvelisib) and Obinutuzumab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Feb 2015to Nov 2016
- Phase
- Phase 1
- 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 Chronic lymphocytic leukemia or Small lymphocytic lymphoma that meets at least one of the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria for treatment (Binet Stage ≥ B and/or Rai Stage ≥ I with symptoms)
- Measurable disease with a lymph node or tumor mass >1.5 cm in at least one dimension as assessed by computed tomography (CT)
- Previous exposure to BTKi therapy and meets at least one of the below criteria:
- Progressive disease while receiving a BTKi therapy, or stable disease as best response after 12 months of receiving a BTKi therapy
- Discontinued a BTKi therapy due to BTKi treatment-related intolerance
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (corresponds to Karnofsky Performance Status [KPS] ≥60%)
- Subjects must be able to receive outpatient treatment and laboratory monitoring (where specifically indicated) at the institution that administers study drug for the entire treatment period
Who cannot join
- Richter's transformation or prolymphocytic leukemia
- Refractory to obinutuzumab (defined as progression or relapse <12 months of receiving obinutuzumab monotherapy or <24 months of receiving an obinutuzumab-containing regimen)
- Progressive disease while previously receiving a PI3K inhibitor (e.g. GS-1101 [idelalisib], duvelisib) or a serious/severe AE related to PI3K inhibitor treatment
- History of severe reaction to prior monoclonal antibody therapy (defined as a Grade 4 event and/or requiring permanent discontinuation)
- Human immunodeficiency virus (HIV) or Human T Cell Lymphotropic Virus 1 (HTLV-1) infection
- Prior, current, or chronic hepatitis B or hepatitis C infection
- History of tuberculosis treatment within the preceding 2 years
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Study site
Boston, Massachusetts, 02115
Study site
Columbus, Ohio, 43210
Study site
Hackensack, New Jersey, 07601
Study site
Houston, Texas, 77030
Study site
La Jolla, California, 92093
Study site
New Hyde Park, New York, 11042
About this study
Official title: A Phase 1b Study of Duvelisib Administered in Combination With Obinutuzumab in Patients With CLL/SLL Previously Treated With a Bruton's Tyrosine Kinase Inhibitor (BTKi) (SYNCHRONY)
To evaluate the safety, pharmacokinetics, and pharmacodynamics of Duvelisib (IPI-145) in combination with obinutuzumab in patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma previously treated with a BTKi.
Read the detailed description
This is a Phase 1b, open-label, dose escalation, safety and tolerability study of Duvelisib (IPI-145) in combination with obinutuzumab in subjects with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma previously treated with a BTKi therapy.
- Being tested
- IPI-145 (duvelisib), Obinutuzumab
- Keywords
- Phase 1b, CLL/SLL, PI3K
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Hereditary Sensory and Autonomic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPI-145 (duvelisib)Drug
Also called Duvelisib
25mg and/or 5mg oral capsule
ObinutuzumabDrug
Also called GAZYVA
1000mg/40mL single-use vials
| Study group | Role | What they receive |
|---|---|---|
| IPI-145 in Combination with Obinutuzumab | Experimental | Not described Receives: Drug: IPI-145 (duvelisib); Drug: Obinutuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicities (DLTs)
Measured: 28 days
Treatment-emergent adverse events (TEAEs)
Measured: Up to 30 days from last dose of study treatment
Secondary outcomes (6)
Overall response rate (ORR)
Measured: Up to 2 years from the first dose of study treatment
Duration of response (DOR)
Measured: Up to 2 years from the first dose of study treatment
Progression-free survival (PFS)
Measured: Up to 2 years from the first dose of study treatment
Overall survival (OS)
Measured: Up to 2 years from the first dose of study treatment or until study treatment is completed, whichever is later
BTK mutation status
Measured: Baseline
Pharmacokinetic (PK) parameters of duvelisib and IPI-656 (major metabolite)
Measured: Week 1, Week 2, Months 2, 4, 7, 11, 15, 19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2014 (estimated)
- Study startFeb 2015
- Primary completionNov 2016
- Study completionNov 2016
Why it stopped: The scope of the program has been reduced to focus resources on studies which can potentially enable the registration of duvelisib.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphocytic Leukemia, ChronicStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- SecuraBio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02292225
- Sponsor's protocol ID
- IPI-145-18
- Status last verified
- Feb 2023
- First submitted
- 10 Nov 2014
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study of Duvelisib Administered in Combination With Obinutuzumab in Patients With CLL/SLL Previously Treated With a Bruton's Tyrosine Kinase Inhibitor (BTKi) (SYNCHRONY)
- ClinicalTrials.gov ID
- NCT02292225
- Acronym / sponsor ID
- IPI-145-18
- Keywords
- Phase 1b, CLL/SLL, PI3K
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The scope of the program has been reduced to focus resources on studies which can potentially enable the registration of duvelisib.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- SecuraBioIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 17 Nov 2014 (estimated)
- 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.
To evaluate the safety, pharmacokinetics, and pharmacodynamics of Duvelisib (IPI-145) in combination with obinutuzumab in patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma previously treated with a BTKi.
Detailed description
This is a Phase 1b, open-label, dose escalation, safety and tolerability study of Duvelisib (IPI-145) in combination with obinutuzumab in subjects with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma previously treated with a BTKi therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IPI-145 in Combination with Obinutuzumab | Experimental | Drug: IPI-145 (duvelisib), Drug: Obinutuzumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥18 years of age
- Diagnosis of Chronic lymphocytic leukemia or Small lymphocytic lymphoma that meets at least one of the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria for treatment (Binet Stage ≥ B and/or Rai Stage ≥ I with symptoms)
- Measurable disease with a lymph node or tumor mass >1.5 cm in at least one dimension as assessed by computed tomography (CT)
- Previous exposure to BTKi therapy and meets at least one of the below criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (corresponds to Karnofsky Performance Status [KPS] ≥60%)
Key exclusion criteria (7 listed)
- Richter's transformation or prolymphocytic leukemia
- Refractory to obinutuzumab (defined as progression or relapse <12 months of receiving obinutuzumab monotherapy or <24 months of receiving an obinutuzumab-containing regimen)
- Progressive disease while previously receiving a PI3K inhibitor (e.g. GS-1101 [idelalisib], duvelisib) or a serious/severe AE related to PI3K inhibitor treatment
- History of severe reaction to prior monoclonal antibody therapy (defined as a Grade 4 event and/or requiring permanent discontinuation)
- Human immunodeficiency virus (HIV) or Human T Cell Lymphotropic Virus 1 (HTLV-1) infection
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 |
|---|---|---|
| IPI-145 (duvelisib)Also: Duvelisib25mg and/or 5mg oral capsule | Drug | IPI-145 in Combination with Obinutuzumab |
| ObinutuzumabAlso: GAZYVA1000mg/40mL single-use vials | Drug | IPI-145 in Combination with Obinutuzumab |
Primary outcome
Dose-limiting toxicities (DLTs)
Time frame: 28 days
Treatment-emergent adverse events (TEAEs)
Time frame: Up to 30 days from last dose of study treatment
6 secondary outcomes
Overall response rate (ORR)
Time frame: Up to 2 years from the first dose of study treatment
Duration of response (DOR)
Time frame: Up to 2 years from the first dose of study treatment
Progression-free survival (PFS)
Time frame: Up to 2 years from the first dose of study treatment
Overall survival (OS)
Time frame: Up to 2 years from the first dose of study treatment or until study treatment is completed, whichever is later
BTK mutation status
Time frame: Baseline
Pharmacokinetic (PK) parameters of duvelisib and IPI-656 (major metabolite)
Time frame: Week 1, Week 2, Months 2, 4, 7, 11, 15, 19
Results and safety
The study was stopped early (reason given: The scope of the program has been reduced to focus resources on studies which can potentially enable the registration of duvelisib.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 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.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IPI-145 (duvelisib) and Obinutuzumab in people with Lymphocytic Leukemia, Chronic and Lymphoma, Small Lymphocytic, run by SecuraBio at 7 sites in 2 countries.
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 8 inclusion and 7 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: stopped early, as of the sponsor's last update on 27 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 7 sites in United States, Canada. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 stopped early (reason given: The scope of the program has been reduced to focus resources on studies which can potentially enable the registration of duvelisib.). Results are not available in the source record.
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?
Dose-limiting toxicities (DLTs) (time frame: 28 days). The study lists 2 primary outcomes in all. 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 27 Feb 2023.