Targeted Intensification by a Preparative Regimen for Patients With High-grade B-Cell Lymphoma Utilizing Standard-dose Yttrium-90 Ibritumomab Tiuxetan (Zevalin) Radioimmunotherapy (RIT) Combined With High-dose BEAM Followed by Autologous Stem Cell Transplantation (ASCT)
- Aged from 18 to 65 years.
- Patient with pathologically proven, high grade B-cell Lymphoma CD 20 positive (WHO
- 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.
- Histological transformation in diffuse large B cell lymphoma, any type of low grade
- 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.