Clinical Trial · NCT00607854

Safety of Ibritumomab Tiuxetan (Zevalin®) in Combination With a Fludarabine-based Reduced Intensity Conditioning (RIC) Regimen (ZEVALLO 2007)

Overview

The purpose of this study is to evaluate the safety and efficacy of Zevalin® in a Reduced Intensity Conditioning regimen followed by allogenic stem cell support in patients with aggressive lymphomas who are responsive to a salvage chemotherapy regimen.

Sponsor

University Hospital, Bordeaux

Phase

Phase 2

Contacts

Geneviève CHENE, Pr (STUDY_CHAIR)

Krimo BOUABDALLAH, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT00607854

Drug / Compound

Ibritumomab tiuxetan

Isotope(s):

Target(s):

CD20 antigen

Ligand Class: Antibodies

Chelator: Tiuxetan

Eligibility

Inclusion

ECOG (Eastern Cooperative Oncology Group) \< 2
With a chemosensitive relapse NHL (at least partial response \> 50% as defined with cheson criteria (See appendix 5)
Eligible for an allogenic transplant
CD20 positive diffuse large B-cell lymphoma in relapse or refractory after two prior regimens or after one regimen including autologous stem cell transplantation, or
And sensitive to relapse's treatment
Patient affiliated to or beneficiary of the National Health Service
Low grade lymphoma CD20 positive for which an indication of allograft is selected
CD20 positive mantle-cell lymphoma in relapse or refractory after two prior regimens or after one regimen including autologous stem cell transplantation or
Low grade lymphoma CD20 positive (follicular lymphoma, marginal zone lymphoma) in histological processing or
Other CD20 positive aggressive lymphoma for which an indication of allograft is selected (Burkitt lymphoma, lymphoblastic lymphoma, intra-vascular lymphoma…..) or
Having or not received previously rituximab
Patients with this lymphoma:
HLA-matched related or unrelated donor 10/10 or 9/10 with C or DQ mismatch without contra-indication for stem cell mobilization

Exclusion

Any contraindication to allogenic stem cell transplantation:
Patient with HIV or HCV positive serology and requiring treatment
Respiratory insufficiency defined as DLCO below 50% of the theoretical value
Hepatic failure defined as a 2-fold increase of bilirubin or transaminases except if due to the lymphoma
Cardiac insufficiency (ejection fraction \< 50% by echocardiography)
Known hypersensitivity to murine antibodies and other proteins, the active ingredients or any of the ingredients of the products under review
Patient under the protection of justice
Patient allografted previously
Renal failure defined as creatinin clearance \< 30 ml/mn
Childbearing or child breastfeeding women
Women who are pregnant or nursing, or man, in the absence of effective contraception during treatment and up to 12 months after stopping treatment
History of cancer