Main info

Identificatie:

HO84 NHL

Sponsor:

HOVON

Working group party:

Lymphoma

Age:

18-80

Stadium:

1st lijn

Echelon:

Level D

Included patients:

600

(of 600)

Active sites:

68

(of 87)

Title:

Randomized phase III study on the effect of early intensification of rituximab in combination with 2-weekly CHOP chemotherapy followed by rituximab maintenance in patients with diffuse large B-cell lymphoma

Timeline

News

Flow

Details

Phase:

Prospective randomized Phase III study

Monitoring Type:

Not any more

Objectives:

To assess in a prospective, multicenter, randomized phase III study in patients with DLBCL:

• The effect of early intensification of rituximab combined with 2-weekly CHOP +G-CSF (CHOP14) in comparison to no intensification of rituximab on the response rate (complete remission and FDG-PET negative partial remission/unconfirmed complete remission) and time to reach response
• The efficacy of maintenance treatment with rituximab in comparison to no further treatment on failure free survival

Eligibility

Inclusion Criteria:

• Patients with a confirmed histologic diagnosis of diffuse large B-cell lymphoma (DLBCL) based upon a representative histology specimen according to the WHO classification (see protocol appendix A)
• DLBCL must be CD20 positive
• Ann Arbor stages II-IV (see protocol appendix C)
• Age 18-65 (inclusive) years and aa-IPI 1-3 (see protocol appendix G) OR Age 66-80 (inclusive) years and aa-IPI 0-3 (see protocol appendix G)
• WHO performance status 0 – 2 (see protocol appendix E)
• Written informed consent

Exclusion Criteria:

• Age 18-65 (inclusive) years and aa-IPI 0 (no risk factors, see protocol appendix G)
• Intolerance of exogenous protein administration
• Severe cardiac dysfunction (NYHA classification III-IV, see protocol appendix F) 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
• Severe pulmonary dysfunction (vital capacity or diffusion capacity < 50% of predicted value) unless clearly related to NHL involvement
• Patients with uncontrolled asthma or allergy, requiring systemic steroid treatment
• Significant hepatic dysfunction (total bilirubin ≥ 30µmol/l or transaminases ≥ 2.5 x upper normal limit), unless related to NHL
• Significant renal dysfunction (serum creatinine ≥ 150 µmol/l or clearance ≤ 60 ml/min), unless related to NHL
• Clinical signs of severe cerebral dysfunction
• Suspected or documented Central Nervous System involvement by NHL
• 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
• Testicular DLBCL
• Primary mediastinal B cell lymphoma
• Transformed indolent lymphoma
• (EBV) post-transplant lymphoproliferative disorder
• Secondary lymphoma after previous chemotherapy or radiotherapy
• Major surgery, other than diagnostic surgery, within the last 4 weeks
• Patients with active uncontrolled infections
• Patients known to be HIV-positive
• Active chronic hepatitis B or C infection
• 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)
• Life expectancy < 6 months
• 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
• History of active cancer during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma

Registration Details

Participating Sites

= Active hospitals

= Inactive hospitals