Main info

Identifier:

HOVON 63 NHL

Sponsor:

HOVON

Included patients:

40

Active sites:

31

(of 31)

Title:

Randomized phase III study of Rituximab with intensified CHOP chemotherapy (R-iCHOP-14) versus Rituximab with High-Dose Sequential Therapy and Autologous Stem Cell Transplantation (R-HDT+ASCT) in Adult Patients (18-65 yrs) with Stage II-IV High-intermediate or High Risk Diffuse Large B-Cell Lymphoma.

Timeline

Flow

Details

Phase:

Prospective randomized Phase III study

Monitoring Type:

Objectives:

Eligibility

Inclusion Criteria:

• Patients with a confirmed histologic diagnosis of DLBCL according to the WHO classification;
• Ann Arbor stage II-IV;
• High-intermediate or high risk NHL according to age-adjusted IPI score (aa IPI=2-3);
• DLBCL must be CD20 positive;
• Age 18-65 years inclusive;
• WHO performance status <= 2;
• Negative preganacy test (if applicable);
• Written informed consent;

Exclusion Criteria:

• Intolerance of exogenous protein administration;
• Severe cardiac dysfunction (NYHA classification II-IV, Appendix F) or LVEF < 45 %;
• Significant renal dysfunction (serum creatinine >= 150 mmol/l), unless related to NHL;
• Significant hepatic dysfunction (total bilirubin >= 30 mmol/l or transaminases >= 2.5 times normal level), unless related to NHL;
• Suspected or documented Central Nervous System involvement by NHL;
• Testicular DLBCL;
• Primary mediastinal B cell lymphoma;
• Patients known to be HIV-positive;
• Patients with active, uncontrolled infections;
• Patients with uncontrolled asthma or allergy, requiring steroid treatment;
• Patient is a lactating woman;
• Unwillingness or not capable to use effective means of anticonception (all men and pre-menopausal women);
• 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/m^2 cumulative) or local radiotherapy in order to control life threatening tumor related symptoms;
• History of active cancer during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma;

Participating Sites

= Active hospitals

= Inactive hospitals