Lymphoma, Large Cell, Diffuse
Conditions
Keywords
Lymphoma, Lymphoma Diffuse, B-Cell lymphoma, Aggressive lymphoma
Brief summary
The purpose of this study is to evaluate the efficacy and the safety of a preparative regimen utilizing standard-dose Yttrium-90 Ibritumomab Tiuxetan (Zevalin) radioimmunotherapy combined with high-dose BEAM followed by ASCT after first line treatment in patients aged from 18 to 65 years with poor prognosis CD 20 Diffuse Large B-Cell lymphoma
Interventions
DRUGZBEAM (Zevalin, BCNU, Etoposide, Aracytine, Melphalan)
Zevalin 0.4 mCi/kg: D-14 BCNU 300 mg/m² : D-6 Etoposide 100 mg/m²/12h : D-6 D-5 D-4 D-3 Aracytine 200 mg/m²/12h : D-6 D-5 D-4 D-3 Melphalan 140 mg/m²: D-2
PROCEDUREASCT
ASCT : D0
DRUGRituximab
Rituximab 250 mg/m² :D-21 D-14
Sponsors
Bayer
Lymphoma Study Association
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Aged from 18 to 65 years. * Patient with pathologically proven, high grade B-cell Lymphoma CD 20 positive (WHO classification) : * Diffuse large B cell lymphoma. * Adverse prognostic factors IPI\>1 * In Complete Remission, or partial response to first line treatment. * Previously treated with chemotherapy regimen containing rituximab: R CHOP or R ACVBP * Chemo-sensitive disease * PET Scan prior transplant * Eligible for autologous stem cell transplantation * With a minimum life expectancy of 3 months. * Negative HIV, HBV and HCV serologies (in the last 4 weeks except after vaccination). * Having previously signed a written informed consent.
Exclusion criteria
* Histological transformation in diffuse large B cell lymphoma, any type of low grade lymphoma * More than one line of treatment. Prior transplantation. Prior exposure to Zevalin * Central nervous system or meningeal involvement by lymphoma. * Contraindication to any drug contained in the chemotherapy regimen. * Any serious active disease or co-morbid medical condition (according to the investigator's decision and information provided in the IDB). * Poor renal function (creatinin level up to 2.5 maximum normal level) unless these abnormalities are related to the lymphoma. * Poor hepatic function (total bilirubin level up to 30 micro mol/l, transaminases up to 2.5 maximum normal level) unless these abnormalities are related to the lymphoma. * Poor bone marrow reserve as defined by neutrophils less than 1.5 G/l or platelets less than 100 G/l * Large bone marrow irradiation more than 40percent. * Bone marrow infiltration * Lack of sufficient autologous hematopoietic stem cells for transplantation. * Prior treatment with murine antibodies * Known hypersensibility to murine antibodies or proteins * Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma. * Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study. * Adult patient unable to give informed consent because of intellectual impairment. * Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event free survival (EFS): events being death from any cause, relapse for complete responders and unconfirmed complete responders, progression during and after treatment and changes of therapy | 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate (ORR) (Complete Response CR and Partial Response PR) | 100 days | 100 days after ASCT |
Countries
France
Outcome results
None listed