NL-OMON23148Not yet recruitingNot Applicable
Randomized phase III study on the effect of early intensification of rituximab in combination with 2-weekly CHOP chemotherapy followed by rituximab maintenance in elderly patients (66-80 years) with diffuse large B-cell lymphoma
Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON) P/a HOVON Data CenterErasmus MC - Daniel den HoedPostbus 52013008 AE RotterdamTel: 010 4391568Fax: 010 4391028e-mail: hdc@erasmusmc.nl0 sites550 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 550
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1. Patients with a confirmed histologic diagnosis of diffuse large B-cell lymphoma (DLBCL) based upon a representative histology specimen according to the WHO classification
- •2. DLBCL must be CD20 positive
- •3. Ann Arbor stages II-IV
- •4. ≥ 66 and £ 80 years
- •5. Age WHO performance status 0 – 2
- •6. Written informed consent
Exclusion Criteria
- •1. Intolerance of exogenous protein administration
- •2. Severe cardiac dysfunction (NYHA classification III-IV or LVEF < 45%. Congestive heart failure or symptomatic coronary artery disease or cardiac arrhythmias not well controlled with medication. Myocardial infarction during the last 6 months
- •3. Severe pulmonary dysfunction (vital capacity or diffusion capacity < 50% of predicted value) unless clearly related to NHL involvement
- •4. Patients with uncontrolled asthma or allergy, requiring systemic steroid treatment
- •5. Significant hepatic dysfunction (total bilirubin ≥30mmol/l or transaminases ≥ 2.5 x upper normal limit), unless related to NHL
- •6. Significant renal dysfunction (serum creatinine ≥ 150 umol/l or clearance ≤ 60 ml/min), unless related to NHL
- •7. Clinical signs of severe cerebral dysfunction
- •8. Suspected or documented Central Nervous System involvement by NHL
- •9. Patients with a history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs
- •10. Testicular DLBCL
- •11. Primary mediastinal B cell lymphoma
- •12. Transformed indolent lymphoma
- •13. (EBV) post-transplant lymphoproliferative disorder
- •14. Secondary lymphoma after previous chemotherapy or radiotherapy
- •15. Major surgery, other than diagnostic surgery, within the last 4 weeks
- •16. Patients with active uncontrolled infections
- •17. Patients known to be HIV-positive
- •18. Active chronic hepatitis B or C infection
- •19. Serious underlying medical conditions, which could impair the ability of the patient to participate in the trial (e.g. ongoing infection, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease)
- •20. Life expectancy < 6 months
- •21. Prior treatment with chemotherapy, radiotherapy or immunotherapy for this lymphoma, except a short course of prednisone (< 1 week) and/or cyclophosphamide (< 1 week and not in excess of 900 mg/m2 cumulative) or local radiotherapy in order to control life threatening tumor related symptoms
- •22. History of active cancer during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma
Investigators
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