EUCTR2006-003844-41-GB
Active, not recruiting
Phase 1
Feasibility study of R-CHOP plus bevacizumab in patients with diffuse large B cell lymphoma (DLBCL) - R-CHOP-B
Royal Marsden NHS Trust0 sitesStarted: February 12, 2007Last updated:
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Royal Marsden NHS Trust
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •a) Age at least 18 years.
- •b) Histological proven diffuse large B cell non\-Hodgkin’s lymphoma (DLBCL) according to the current World Health Organization classification20 including all morphological variants. The B cell nature of the proliferation must be verified by the positivity with an anti\-CD20 antibody. All histology will be reviewed by a central Lymphoma Trials Office pathology panel.
- •c) No previous chemotherapy, radiotherapy or other investigational drug for this indication.
- •d) Stage II, III and IV disease
- •e) WHO performance status 0\<2\.
- •f) Adequate bone marrow function with platelets \> 100x109/l; neutrophils \> 1\.5x109/l at the time of study entry unless attributed to bone marrow infiltration by lymphoma.
- •g) Serum creatinine \< 150umol/l, serum bilirubin \< 35umol/l and transaminases \< 2\.5x upper limit of institutional normal range unless attributed to lymphoma.
- •h) Normal MUGA or echocardiogram without any areas of abnormal contractility. Patients must have an acceptable left ventricular ejection fraction (LVEF) of at least 50%.
- •i) No concurrent uncontrolled medical condition.
- •j) No active malignant disease other than basal or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix in the last 10 years.
Exclusion Criteria
- •a) Lymphomatous involvement of, or lymphoma arising in the gastrointestinal tract.
- •b)T\-cell lymphoma or transformed follicular lymphoma.
- •c) Previous history of treated or non\-treated indolent lymphoma. However, patients not previously diagnosed with an indolent lymphoma, who have diffuse large B\-cell lymphoma with some small cell infiltration in bone marrow or lymph node may be included.
- •d) Past history of heart failure or uncontrolled angina pectoris.
- •e) Central nervous system, meningeal involvement or cord compression by
- •f) Absence of clinically significant (i.e. active) cardiovascular disease e.g. cerebrovascular accidents (\< 6 months prior to randomization), any myocardial infarction (\< 1 year prior to randomization), uncontrolled hypertension while receiving chronic medication, unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication abnormal contractility on echocardiography or nuclear medicine examination \[MUGA]). Cardiac contraindication to doxorubicin.
- •g) Neurological contra\-indication to vincristine (e.g. pre\-existing diabetic neuropathy).
- •h) Any other serious active disease.
- •i) General status that does not allow the administration of 8 courses of CHOP according to the investigator.
- •j) Positive serology for HIV, Hepatitis B or Hepatitis C
Investigators
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