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

Nantes University Hospital (NUH)

Status and phase: Completed; Phase 2

Conditions: B-Cell Lymphoma

Treatments: Drug: Rituximab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00965289

GOELAMS 074

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

HDT combined with rituximab before ASCT

Experimental group

Description:

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.

Treatment:

Drug: Rituximab