CHOP-OR
Trial overview
Phase II single-arm NCRI feasibility study of CHOP in combination with ofatumumab in induction and maintenance of patients with newly diagnosed Richter's Syndrome.
The CHOP-OR trial is intended to discover whether the combination of chemotherapy and ofatumumab improves outcomes compared to chemotherapy alone, and also whether there are any rare side effects of ofatumumab in combination with chemotherapy which we do not know about.
Inclusion criteria
1. Signed written informed consent prior to performing any study-specific procedures.
2. Patients with B-CLL and newly diagnosed not previously treated and biopsy proven DLBCL Richter’s transformation.
3. Computerised tomography (CT) scan performed within 6 weeks prior to starting treatment..
4. ECOG Performance Status of 0, 1, 2 or 3.
5. Age 18 years and over.
Exclusion criteria
1. Treatment for DLBCL within 6 months prior to registration.
2. Known CNS involvement of B-CLL.
3. Any other malignancy that requires active treatment with the exception of basal cell carcinoma and non-invasive squamous cell carcinoma.
4. 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.
5. 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. (In addition, if negative for HBsAg but HBcAb 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.
6. Clinically significant cardiac disease including unstable angina, congestive heart failure, and arrhythmia requiring therapy, with the exception of extra systoles or minor conduction abnormalities.
7. Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease.
8. History of significant cerebrovascular disease in last 6 months.
9. Known HIV positive.
10. Known or suspected hypersensitivity to components of investigational product.
11. 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).
12. Current participation in any other interventional clinical study.
13. Patients known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency or psychological disorder).
14. Breast feeding women or women with a positive pregnancy test at screening.
15. 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.
Contact details
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Tags
chop-or richter's syndrome