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

Phase 3

Completed

• Conditions: Diffuse large B-cell lymphoma; lymphoma; 10025320

• Registration Number: NL-OMON47490
• Lead Sponsor: HOVO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 460

Inclusion Criteria

For first randomization:, - 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 appendix A), - DLBCL must be
CD20 positive, - Ann Arbor stages II-IV (see appendix C), - Age 18-65 years and
age-adjusted IPI 1-3 OR age 66-80 years and age-adjusted IPI 0-3 , - WHO
performance status 0 - 2 (see appendix E) , - Written informed consent, For
second randomization:, Patients achieving a CR (or FDG-PET negative PR/CRu)
after 6 (elderly) or 8 (young patients) cycles of R-CHOP14 will be randomized
to maintenance treatment with rituximab or no further treatment., - Patients in
complete remission or FDG-PET negative partial remission/unconfirmed complete
remission at least 4 weeks after the last cycle of R-CHOP14 (including last
rituximab administration), - Time interval since last cycle of R-CHOP14
(including last rituximab administration) between 4 and 8 weeks, - No
rituximab-related adverse event necessitating stopping of rituximab
administration, - No active infection, - Written informed consent

Exclusion Criteria

-Age 18-65 (inclusive) years and aa-IPI 0 (no risk factors), -Intolerance of
exogenous protein administration, -Severe cardiac dysfunction (NYHA
classification III-IV, see 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 >= 30mmol/l or
transaminases >= 2.5 x upper normal limit), unless related to NHL , -
Significant renal dysfunction (serum creatinine >= 150 umol/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

Study & Design

• Study Type: Interventional
• Study Design: Not specified