A Study Combining Ibrutinib With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With CD20-Positive B-Cell Non Hodgkin Lymphoma

• Status: Completed
• Trial end date: 2014-09-04
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to identify if, and at what dose, ibrutinib may be administered with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) and to document responses of this combination in patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Collaborator: Pharmacyclics LLC.
• Treatments: Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Prednisone; Rituximab; Vincristine

Criteria

Inclusion Criteria:

• Histopathologically-confirmed CD20-positive B-cell non Hodgkin lymphoma disease for whom R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) is an appropriate therapy (diffuse large B-cell lymphoma, mantle cell lymphoma, or follicular lymphoma); for the expansion cohort, at least 1 cohort will only include patients with newly diagnosed diffuse large B-cell lymphoma

• Stage I AX (bulk defined as single lymph node mass >=10 cm in diameter) to Stage IV disease

• At least 1 measurable site of disease based on the Revised Response Criteria for Malignant Lymphoma

• Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2

• Adequate bone marrow, liver, and renal function

Exclusion Criteria:

• History of protocol-defined disallowed therapies

• Prior multidrug chemotherapy treatment for lymphoma

• History of stroke or intracranial hemorrhage within 6 months prior to the first dose of study drug

• Major surgery within 3 weeks before enrollment

• Known bleeding diatheses, platelet dysfunction disorders, or requires therapeutic anticoagulation

• Known lymphoma of the central nervous system

• Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, New York Heart Association Class III or IV heart failure, uncontrolled angina, pericardial disease, cardiac amyloidosis, clinically significant cardiac arrhythmia, or left ventricular ejection fraction outside of institutional limits

• Active systemic infection requiring treatment including hepatitis B and hepatitis C infection

• Documented or suspected human immunodeficiency virus infection

• Diagnosed or treated for a malignancy other than non-Hodgkin lymphoma except; adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ of the breast, or other solid tumors curatively treated with no evidence of disease for >5 years

• Has any condition that, in the opinion of the investigator, would make study participation not be in the best interest (eg, compromise the well-being) of the patient or that could prevent, limit, or confound the protocol-specified assessments