Status:
COMPLETED
Safety of Ibritumomab Tiuxetan (Zevalin®) in Combination With a Fludarabine-based Reduced Intensity Conditioning (RIC) Regimen (ZEVALLO 2007)
Lead Sponsor:
University Hospital, Bordeaux
Collaborating Sponsors:
Bayer
Conditions:
Diffuse Large B-Cell Lymphoma
Mantle Cell Lymphoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 w...
Detailed Description
The benefit of Zevalin® in the setting of autologous stem cell transplantation has been largely reported. The addition of Zevalin® to a fludarabine-based Reduced Intensity Conditioning regimen has bee...
Eligibility Criteria
Inclusion
- Age ≥ 18 and ≤ 65
- Patients with this lymphoma:
- 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
- CD20 positive mantle-cell lymphoma in relapse or refractory after two prior regimens or after one regimen including autologous stem cell transplantation or
- Other CD20 positive aggressive lymphoma for which an indication of allograft is selected (Burkitt lymphoma, lymphoblastic lymphoma, intra-vascular lymphoma…..) or
- Low grade lymphoma CD20 positive (follicular lymphoma, marginal zone lymphoma) in histological processing or
- Low grade lymphoma CD20 positive for which an indication of allograft is selected
- And sensitive to relapse's treatment
- HLA-matched related or unrelated donor 10/10 or 9/10 with C or DQ mismatch without contra-indication for stem cell mobilization
- ECOG (Eastern Cooperative Oncology Group) \< 2
- Having or not received previously rituximab
- With a chemosensitive relapse NHL (at least partial response \> 50% as defined with cheson criteria (See appendix 5)
- Eligible for an allogenic transplant
- With a signed informed consent (obtained on the screening day at the latest and before any investigation)
- Patient affiliated to or beneficiary of the National Health Service
Exclusion
- Patient allografted previously
- History of cancer
- Patient with HIV or HCV positive serology and requiring treatment
- 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
- Any contraindication to allogenic stem cell transplantation:
- Cardiac insufficiency (ejection fraction \< 50% by echocardiography)
- Respiratory insufficiency defined as DLCO below 50% of the theoretical value
- Renal failure defined as creatinin clearance \< 30 ml/mn
- Hepatic failure defined as a 2-fold increase of bilirubin or transaminases except if due to the lymphoma
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00607854
Start Date
February 1 2008
End Date
November 1 2011
Last Update
October 5 2016
Active Locations (12)
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1
Service d'hématologie - CHU de Besançon
Besançon, France, 25030
2
Service des maladies du sang - Hôpital Haut-Lévêque - avenue de magellan
Bordeaux - Pessac, France, 33600
3
Service d'hématologie - CHU Hôtel Dieu Clermont-Ferrand
Clermont-Ferrand, France, 63000
4
Service de médecine nucléaire - Centre de Lutte contre le Cancer de la Région Auvergne Jean Perrin
Clermont-Ferrand, France, 63011