Chronic Lymphocytic Leukemia Clinical Trial
Duvelisib With Obinutuzumab in Patients With CLL/SLL Previously Treated With a 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.
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.
≥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
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
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There are 7 Locations for this study
La Jolla California, 92093, United States
Boston Massachusetts, 02115, United States
Hackensack New Jersey, 07601, United States
New Hyde Park New York, 11042, United States
Columbus Ohio, 43210, United States
Houston Texas, 77030, United States
Montreal Quebec, H3T 1, Canada
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