Duvelisib With Obinutuzumab in Patients With CLL/SLL Previously Treated With a BTKi (SYNCHRONY)
NCT ID: NCT02292225
Last Updated: 2023-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
3 participants
INTERVENTIONAL
2015-02-28
2016-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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IPI-145 in Combination with Obinutuzumab
IPI-145 (duvelisib)
25mg and/or 5mg oral capsule
Obinutuzumab
1000mg/40mL single-use vials
Interventions
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IPI-145 (duvelisib)
25mg and/or 5mg oral capsule
Obinutuzumab
1000mg/40mL single-use vials
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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SecuraBio
INDUSTRY
Responsible Party
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Locations
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La Jolla, California, United States
Boston, Massachusetts, United States
Hackensack, New Jersey, United States
New Hyde Park, New York, United States
Columbus, Ohio, United States
Houston, Texas, United States
Montreal, Quebec, Canada
Countries
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Other Identifiers
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IPI-145-18
Identifier Type: -
Identifier Source: org_study_id
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