Diffuse Large B Cell Lymphoma of the Adult: Randomization Between High Dose Chemotherapy With Rituximab and CHOP 14-Rituximab

Nantes University Hospital (NUH)

Status: Completed

Conditions: Lymphoma, Large-Cell, Diffuse

Treatments: Drug: CHOP+RITUXIMAB; Drug: CEEP-RITUXIMAB

Study type: Interventional

Funder types: Other

Identifiers

NCT00561379

BRD 04/4-O

Details and patient eligibility

About

The aim of the protocol is to compare the outcome of patients with DLBCL stage II bulky, III or IV with 1 to 3 adverse prognostic factors according to the International prognostic index. Patients with eligibility criteria and who gave informed consent will be randomised between CHOP-14- Rituximab x 8 courses and High dose chemotherapy with rituximab including autologous stem cell support. The aim of the study is to compare the Event free survival between the two arms and to gain insight into the prognostic significance of several biological markers gathered at the time of diagnosis/randomisation ( i.e. Fcgamma R III A genotyping, DNA profile and BCL é expression).

Full description

Diffuse Large B Cell Lymphoma not previously treated

Enrollment: 350 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 et ≤ 60 and male and female
• Diffuse large B cell lymphoma according to WHO classification phénotype B CD 20 +
• Stage I et II tumor bulk > 7 cm and stage III et IV Ann Arbor.
• Non previously treated
• HIV négative
• Signed informed consent

Exclusion criteria

• Age < 18 and/or > 60 ans
• NHL not DLBCL
• Lymphoblastic Lymphoma
• Burkitt's Lymphoma
• Low grade Lymphoma transformed
• Primary CNS Lymphomal
• Post- transplantation Lymphoma
• CD20 negative
• Ann Arbor stage I or II without tumor bulk > 7 cm
• Previous treatment
• HIV positive
• Contre-indication to Rituximab use according to SmPC
• Contre-indication to high dose chemotherapy due to organ failure not related to the lymphoma
• Cancer or history of cancer with the exception of in situ cancer of the cervix or non-invasive skin epithelioma
• Patient not able to understand the proposed treatments
• Refusal to sign the informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

350 participants in 2 patient groups

1

Active Comparator group

Treatment:

Drug: CHOP+RITUXIMAB

2

Active Comparator group

Treatment:

Drug: CEEP-RITUXIMAB