High-dose Chemotherapy With Rituximab for Adults With Aggressive Large B-cell Lymphoma

Study Overview
=================
Brief Summary
-----------------
A prospective pilot trial was proposed to patients with DLBCL, with IH or high adjusted IPI, up to the age of 60 y.o. This program consisted of 2 courses of high-dose R-CHOP-like regimen, followed by a course of high-dose methotrexate with cytarabin. For patients who achieved at least a PR, ASCT started with a BEAM regimen.

Detailed Description
-----------------
Superiority of HDT with autologous stem cell transplantation (ASCT) in the upfront treatment of poor-risk DLBCL remains an option for intermediate-high (IH) or high IPI young adults. We updated results of the prospective trial Goelams 074 to evaluate long-term efficacy and toxicity in 42 patients who underwent HDT with ASCT.

Official Title
-----------------
Front-line High-dose Chemotherapy (HDT) Combined With Rituximab for Adults With Aggressive Large B-cell Lymphoma (DLBCL) : Goelams 074 Trial.

Conditions
-----------------
B-Cell Lymphoma

Intervention / Treatment
-----------------
* Drug: Rituximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 to 60 y.o Aggressive Large B-Cell Lymphoma (CD20+) Ann Arbor stage III, IV IH or high adjusted IPI signed inform consent Exclusion Criteria: Age < 18 ou > 60 y.o other type of lymphoma serology VIH + other neoplasms apart from basal cell carcinoma or situ carcinoma

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HDT combined with rituximab before ASCT<br>The study treatment consisted on 2 courses of high-dose R-CHOP-like regimen, followed by a course of high-dose methotrexate with cytarabin. For patients who achieved at least a PR, ASCT started with a BEAM regimen. | Drug: Rituximab<br>* Rituximab infusion on day 1 dose: 375mg/m²<br>* Other names: Mabthera®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CR rate after 3 high dose chemotherapy courses |  | safety/efficacy of chemotherapy treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CR and PR rate at the end of the study treatment |  | safety/efficacy of treatment30 days after the end of post ASCT aplasia | 
| PFS,EFS and OS |  | safety/efficacy of study treatment | 
| Tolerance of Rituximab combined with chemotherapy |  | safety/efficacy of immunotherapy combined with chemotherapy treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aggressive large B-cell lymphoma (DLBCL), Intensive chemotherapy, Rituximab, ASCT