Targeted Intensification With ZBEAM and Autologous Stem Cell Transplantation in Patients With High-grade B-Cell Lymphoma (ZBEAM2)

Lymphoma Study Association (LYSA)

Status and phase

Completed

Phase 2

Conditions

Lymphoma, Large Cell, Diffuse

Treatments

Drug: Rituximab

Procedure: ASCT

Drug: ZBEAM (Zevalin, BCNU, Etoposide, Aracytine, Melphalan)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00689169

ZBEAM2

2007-000270-23 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

75 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.