CHOP-OR

Phase II single arm multi-centre NCRI feasibility study of CHOP combined with Ofatumumab in induction and maintenance for patients with newly diagnosed Richter’s syndrome

The study has been added to the NIHR CRN Portfolio database, study ID: 9476.

1. Does the combination of chemotherapy and Ofatumumab improve outcomes compared to chemotherapy on its own?
2. Are there any rare side effects of Ofatumumab in combination with chemotherapy that we do not know about?

STUDY STATUS

If you are interested in participating in this trial please discuss this with your Doctor and if necessary ask to be referred to one of the hospitals in the list of active sites above.

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. ECOG Performance Status of 0, 1, 2 or 3.
4. Age 18 years and over.
5. Computerised tomography (CT) scan performed within 6 weeks prior to starting treatment.

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 two months after last dose of ofatumumab. Adequate contraception is defined as abstinence, hormonal birth control or intrauterine devices.

OBJECTIVES

Primary:

• Evaluate overall response rate (ORR) to CHOP-O according to the Revised Response Criteria for Malignant Lymphoma (Cheson criteria).

Secondary:

• Feasability of recruitment.
• Progression free survival (PFS).
• Overall Survival (OS).
• The clinical benefit and changes in patient reported outcome measures (PRO).
• Safety and tolerability.

OpenClinica

Data submission for this trial is via electronic submission of data in OpenClinica. OpenClinica is the world's leading open source clinical trial software for electronic data capture and clinical data management.  Information on how to use OpenClinica can be found on the OpenClinica Training page using the link below. It contains a user guide and instructional videos to show you how to use OpenClinica.  After reviewing these if you have any other queries please contact a member of the trial team at OCTO.

 

Oncology Clinical Trials Office (OCTO)

Registration Service Mon-Fri 9-5 (UK Time):

 Fax: 0800 389 1629 (24hrs)

 

CHOP-OR Trial Office 01865 617088 

Email: CHOP-OR@octo-oxford.org.uk

Website: www.octo-oxford.org.uk