Randomized phase III study of Rituximab with intensified CHOP chemotherapy vs. Rituximab with High-Dose Sequential Therapy and Autologous Stem Cell Transplantation in Adult Patients (18-65 yrs) with Stage II-IV High-intermediate or High Risk DLBCL.
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 250
1. Patients with a confirmed histologic diagnosis of DLBCL according to the WHO classification;
2. Ann Arbor stage II-IV;
3. High-intermediate or high risk NHL according to age-adjusted IPI score (aa IPI=2-3);
4. DLBCL must be CD20 positive;
5. Age 18-65 years inclusive;
6. WHO performance status <= 2;
7. Negative pregnancy test (if applicable);
8. Written informed consent.
1. Intolerance of exogenous protein administration;
2. Severe cardiac dysfunction (NYHA classification II-IV,
Appendix F) or LVEF < 45 %;
3. Significant renal dysfunction (serum creatinine >= 150
mumol/l), unless related to NHL;
4. Significant hepatic dysfunction (total bilirubin >= 30 mumol/l or
transaminases >= 2.5 times normal level), unless related to NHL;
5. Suspected or documented Central Nervous System involvement by NHL;
6. Testicular DLBCL;
7. Primary mediastinal B cell lymphoma;
8. Patients known to be HIV-positive;
9. Patients with active, uncontrolled infections;
10. Patients with uncontrolled asthma or allergy, requiring steroid treatment;
11. Patient is a lactating woman;
12. Unwillingness or not capable to use effective means of anticonception (all men and pre-menopausal women);
13. Prior treatment with chemotherapy, radiotherapy or immunotherapy for this lymphoma, except a short course of
prednisone (< 1 wk) and/or cyclophosphamide (< 1 wk and not
in excess of 900 mg/m2 cumulative) or local radiotherapy in order to control life threatening tumor related symptoms;
14. 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 Event-free survival (i.e. time from registration to induction failure<br>(i.e. less than PR after 3 x R-iCHOP, no CR (CRu) after 6 RiCHOP (arm A) or ASCT (arm B), death, progression or relapse<br>whichever occurs first); the time to failure of patients with induction failure (less than PR after 3 x R-iCHOP) is set at one<br>day.
- Secondary Outcome Measures
Name Time Method 1. Complete response (including CRu);<br>2. Progression on protocol (progression or relapse after initial PR or CR during protocol treatment);<br>3. Overall survival measured form the time of registration;<br>4. Disease-free interval (duration of the first CR) measured from the time of achievement of CR (including CRu) after protocol treatment to day of relapse or death from any cause (whichever<br>occurs first).