Targeted Intensification With ZBEAM and Autologous Stem Cell Transplantation in Patients With High-grade B-Cell Lymphoma
Targeted Intensification With ZBEAM and Autologous Stem Cell Transplantation in Patients With High-grade B-Cell Lymphoma
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
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.