Study of Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone (CHOP) With Ofatumumab in Patients With Richter's Syndrome

• Status: Completed
• Trial end date: 2016-04-19
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate Ofatumumab in combination with CHOP (cyclophosphamide, hydroxydaunorubicin (doxorubicin), Oncovin (vincristine), and prednisone/prednisolone, the standard chemotherapy treatment) in induction and maintenance treatment of Richter's Syndrome. This study aims to evaluate the overall response rate to CHOP-O (CHOP in combination with Ofatumumab) according to the Revised Response Criteria for Malignant Lymphoma. The hypothesis would be that treatment with CHOP-O for Richter's Syndrome (RS), shows a difference in overall survival (more people living longer), when compared with the standard treatment of CHOP-R (CHOP chemotherapy plus Rituximab).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oxford
• Collaborators: Cancer Research UK; GlaxoSmithKline; NCRI CLL Subgroup; Oxford University Hospitals NHS Trust
• Treatments: Antibodies, Monoclonal; Ofatumumab

Criteria

Inclusion Criteria:

• Signed written informed consent prior to performing any study-specific procedures

• Patients with B-CLL and newly diagnosed not previously treated and biopsy proven DLBCL Richter's transformation

• Computerized tomography (CT) scan performed within 6 weeks prior to starting treatment.

• ECOG (Eastern Cooperative Oncology Group) Performance Status of 0, 1, 2 or 3

• Age 18 years and over.

Exclusion Criteria:

• CHOP or CHOP-like anthracycline containing treatment for DLBCL within 6 months prior to registration.

• Known central nervous system (CNS) involvement of B-CLL.

• Any malignancy that requires active treatment with the exception of basal cell carcinoma and non-invasive squamous cell carcinoma.

• Chronic or ongoing active infectious disease requiring systemic treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active hepatitis.

• Subjects meeting any of the following criteria must not be enrolled in the study:

• Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg (the surface antigen of the Hepatitis-B-Virus). In addition, if negative for HBsAg but HBcAb (Hepatitis B core Antibody) positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded. Consent will be sought prior to any test being performed.

• Clinically significant cardiac disease including unstable angina, uncontrolled congestive heart failure, and arrhythmia requiring therapy, with the exception of extra systoles or minor conduction abnormalities.

• Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease.

• History of significant cerebrovascular disease in last 6 months.

• Known Human immunodeficiency virus (HIV) positive.

• Known or suspected hypersensitivity to components of investigational product.

• Patients who have received treatment with any non-marketed drug substance or experimental therapy within 4 weeks prior to Visit 2 (start of treatment, cycle 1, day 1).

• Current participation in any other interventional clinical study.

• Patients known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency or psychological disorder).

• Breast feeding women or women with a positive pregnancy test at screening.

• Women of childbearing potential not willing to use adequate contraception during study and for 12 months after last dose of Ofatumumab. Adequate contraception is defined as abstinence, hormonal birth control or intrauterine devices.