Randomized phase III study of Rituximab with intensified CHOP chemotherapy versus Rituximab with High-Dose Sequential Therapy and Autologous Stem Cell Transplantation in Adult Patients (18-65 years) with Stage II-IV High-intermediate or High Risk DLBC

Completed

• Conditions: on Hodgkin's lymphoma (NHL); Cancer; Lymphoma

• Registration Number: ISRCTN46136861
• Lead Sponsor: Dutch Haemato-oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-13
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

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 7. Negative pregnancy test (if applicable)
8. Written informed consent

Exclusion Criteria

1. Intolerance of exogenous protein administration
2. Severe cardiac dysfunction (NYHA classification II-IV) 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 contraconception (all men and pre-menopausal women)
13. 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
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