Main info

Identifier:

HOVON 46 NHL

Sponsor:

HOVON

Included patients:

268

Active sites:

0

(of 51)

51 sites are pending

Title:

A randomized phase III study of chimeric anti-CD20 monoclonal antibody (Rituximab) with 2-weekly CHOP chemotherapy in elderly patients with intermediate- or high-risk non-Hodgkin?s lymphoma.

Timeline

Flow

Details

Phase:

Prospective randomized Phase III study

Monitoring Type:

Objectives:

Eligibility

Inclusion Criteria:

• Patients with a confirmed histologic diagnosis of NHL according to the WHO classification (Appendix A):

a. Mantle cell lymphoma (MCL)
b. Follicular lymphoma (grade III) (FL III)
c. Diffuse large B-cell lymphoma (DLBCL)

• Low-intermediate, high-intermediate or high risk NHL according to age-adjusted IPI score (appendix G)
• NHL must be CD20 positive.
• Age >= 65 years
• WHO performance status <= 2 (see appendix E)
• 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 creatinin >= 150 umol/l), unless related to NHL
• Significant hepatic dysfunction (total bilirubin >= 30 umol/l or transaminases >= 2.5 times normal level), unless related to NHL
• Suspected or documented Central Nervous System involvement by NHL
• Patients known to be HIV-positive
• Patients with active, uncontrolled infections
• Patients with uncontrolled asthma or allergy, requiring steroid treatment
• Prior treatment with chemotherapy, radiotherapy or immunotherapy for this lymphoma, except local radiotherapy in case of (potential) organ dysfunction by localized lymphoma mass or infiltration
• 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