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
- Conditions
- Diffuse large B-cell lymphoma
- Registration Number
- NL-OMON23148
- Lead Sponsor
- 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.nl
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 550
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method First randomization:<br>- Response rate (complete remission and FDG-PET negative partial remission or unconfirmed complete remission) <br>Second randomization:<br>- Failure free survival (measured from the date of second randomization)
- Secondary Outcome Measures
Name Time Method First randomization:<br>- Failure free survival measured from the date of registration. Patients still alive or lost to follow up are censored at the last day they were known to be alive<br>- Overall survival measured from the time of registration<br>- Time to reach response<br>- Toxicity<br>Second randomization:<br>- Overall survival<br>- Toxicity