Clinical trial · Interventional
Study of Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone (CHOP) With Ofatumumab in Patients With Richter's Syndrome
Single Arm NCRI Feasibility Study of CHOP in Combination With Ofatumumab in Induction and Maintenance for Patients With Newly Diagnosed Richter's Syndrome
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Richter's Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ofatumumab | Drug | Ofatumumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Ofatumumab
- description
- Single arm study
- interventionNames
- Drug: Ofatumumab
Primary outcomes (1)
- measure
- Objective response
- timeFrame
- Week 20
- description
- Objective response as defined by the revised response criteria for malignant lymphoma (Cheson et al, JCO, Vol 25, No 5, 2007). Patients will be classified as responders/non-responders as follows: complete remission (CR), nodular partial remission (nPR) and partial remission (PR) are classified as responders; while stable disease (SD) and progressive disease (PD) are classified as non-responders. Non-evaluable patients will be classified as non-responders.
Secondary outcomes (7)
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDEyre TA, Clifford R, Roberts C, Boyle L, Francis A, Schuh A, Dutton SJ. Single arm NCRI phase II study of CHOP in combination with Ofatumumab in induction and maintenance for patients with newly diagnosed Richter's syndrome. BMC Cancer. 2015 Feb 13;15:52. doi: 10.1186/s12885-015-1048-9. PMID 25775024