Status:
TERMINATED
Duvelisib With Obinutuzumab in Patients With CLL/SLL Previously Treated With a BTKi (SYNCHRONY)
Lead Sponsor:
SecuraBio
Conditions:
Lymphocytic Leukemia, Chronic
Lymphoma, Small Lymphocytic
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 previous...
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 L...
Eligibility Criteria
Inclusion
- ≥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
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT02292225
Start Date
February 1 2015
End Date
November 1 2016
Last Update
February 27 2023
Active Locations (7)
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1
La Jolla, California, United States, 92093
2
Boston, Massachusetts, United States, 02115
3
Hackensack, New Jersey, United States, 07601
4
New Hyde Park, New York, United States, 11042