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

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lymphoma Study Association
• Collaborator: Bayer
• Treatments: Cytarabine; Etoposide; Etoposide phosphate; Melphalan; Rituximab

Criteria

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.