B-Cell Lymphoma
Conditions
Keywords
Aggressive large B-cell lymphoma (DLBCL), Intensive chemotherapy, Rituximab, ASCT
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.
Interventions
DRUGRituximab
Rituximab infusion on day 1 dose: 375mg/m²
Sponsors
French Innovative Leukemia Organisation
Hoffmann-La Roche
Nantes University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CR rate after 3 high dose chemotherapy courses | safety/efficacy of chemotherapy treatment |
Secondary
| Measure | 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 |
Countries
France
Outcome results
None listed