A Study of Two Associations of Rituximab and Chemotherapy, With a PET-driven Strategy, in Lymphoma

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This Phase II study randomized R-ACVBP and R-CHOP as induction treatment in patients from 18 to 59 with DLBCL CD20+ lymphoma and 2 or 3 adverse prognostic factors of the age-adjusted IPI. The consolidation treatment is allocated according to the response to induction treatment assessed by PET after the 2nd and 4th induction cycles.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospices Civils de Lyon
• Treatments: Rituximab

Criteria

Inclusion Criteria:

• Patient with histologically proven CD20+ diffuse large B-cell lymphoma (WHO classification).

• Age from18 to 59 years, eligible for transplant.

• Patient not previously treated.

• Baseline FDG-PET Scan (PET0) performed before any treatment with at least one hypermetabolic lesion.

• Index prognostic factors (IPI) 2 or 3.

• With a minimum life expectancy of 3 months.

• Negative HIV, HBV and HCV serologies £ 4 weeks (except after vaccination).

• Having previously signed a written informed consent.

Exclusion Criteria:

• Any other histological type of lymphoma.

• Any history of treated or non-treated indolent lymphoma. However, patients not previously diagnosed and having a diffuse large B-cell lymphoma with some small cell infiltration in bone marrow or lymph node may be included.

• Central nervous system or meningeal involvement by lymphoma.

• Contra-indication to any drug contained in the chemotherapy regimens.

• Poor renal function (creatinin level >150 mmol/l), poor hepatic function (total bilirubin level >30 mmol/l, transaminases >2.5 maximum normal level) unless these abnormalities are related to the lymphoma.

• Poor bone marrow reserve as defined by neutrophils <1.5 G/l or platelets <100 G/l, unless related to bone marrow infiltration.

• Any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ)cervical carcinoma.

• Any serious active disease (according to the investigator's decision).

• Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy.

• Pregnant or lactating women or women of childbearing potential not currently practicing an adequate method of contraception

• Adult patient under tutelage.

• Impossibility to performed a baseline PET scan (PET0) before randomization and treatment beginning