R-ACVBP and DA-EPOCH-R in Patients With Non-GCB DLBCL

• Status: Unknown status
• Trial end date: 2021-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, open-label, multi-center, phase 3 study evaluating the efficacy of R-ACVBP and DA-EPOCH-R in patients with newly diagnosed non-germinal b-cell-like diffuse large B-cell lymphoma

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nanfang Hospital of Southern Medical University
• Treatments: Bleomycin; Cyclophosphamide; Doxorubicin; Etoposide; Etoposide phosphate; Liposomal doxorubicin; Prednisone; Rituximab; Vincristine; Vindesine

Criteria

Inclusion Criteria:

• Patient with histologically proven CD20+ diffuse large B cell lymphoma (WHO Classification),

• aaIPI>1,

• Age >18 and < 61 years,

• Negative HIV serologies 4 weeks

• Ability to understand and willingness to sign a written informed consent

Exclusion Criteria:

• Any other histological type of lymphoma. Any history of treated or non-treated indolent lymphoma.

• Central nervous system or meningeal involvement by lymphoma.

• Contraindication to any drug contained in the chemotherapy regimens.

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

• Poor renal function (creatinin level>150µmol/l), poor hepatic function (total bilirubin level>30mmol/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.

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

• Pregnant or lactating women.