Phase 2 study of the combination of ibrutinib plus venetoclax in subjects with treatment-naïve chronic lymphocytic leukemia / small lymphocytic lymphoma

Pharmacyclics LLC0 sites150 target enrollmentDecember 27, 2016

Overview

No summary available.

Registry

who.int

Start Date

December 27, 2016

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Diagnosis of CLL/SLL that meets IWCLL diagnostic criteria.
•2\. Active disease meeting at least 1 of the following IWCLL criteria for requiring treatment:
•\- Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia
•\-Massive, progressive, or symptomatic splenomegaly
•\-Massive nodes or progressive or symptomatic lymphadenopathy
•\-Progressive lymphocytosis
•\-Constitutional symptoms
•3\. Measurable nodal disease by computed tomography (CT).
•4\. Adequate hematologic function independent of transfusion and growth factor support for at least 7 days prior to screening, with the exception of pegylated G\-CSF (pegfilgrastim) and darbopoeitin which require at least 14 days prior to screening defined as:
•\- Absolute neutrophil count (ANC) \>750 cells/µL (750 cells/mm3 or 0\.75 x 109/L)

•1\. Any prior therapy (including but not limited to chemotherapy, targeted therapy, immunomodulating therapy, radiotherapy, and/or monoclonal antibody) used for treatment of CLL or SLL.
•2\. History of other malignancies, except:
•\- Malignancy treated with curative intent and with no known active disease present for \=3 before the first dose of study drug and felt to be at low risk for recurrence by the treating physician
•\-Adequately treated non\-melanoma skin cancer or lentigo maligna without evidence of disease
•\- Adequately treated carcinoma in situ without evidence of disease
•3\. Known or suspected history of Richter’s transformation.
•4\. Concurrent administration of \>20 mg/day of prednisone within 7 days of initiation of study drug unless indicated for prophylaxis or management of allergic reactions (eg, contrast).
•5\. Known hypersensitivity to one or more study drugs.
•6\. Known allergy to xanthine oxidase inhibitors and/or rasburicase for subjects at risk for TLS.
•7\. Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug.