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

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

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 who are responsive to a salvage chemotherapy regimen.

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

Details

• Lead Sponsor: University Hospital, Bordeaux
• Collaborator: Bayer
• Treatments: Antibodies, Monoclonal; Fludarabine; Fludarabine phosphate

Criteria

Inclusion Criteria:

• Age ≥ 18 and ≤ 65

• Patients with this lymphoma:

1. 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

2. CD20 positive mantle-cell lymphoma in relapse or refractory after two prior regimens or after one regimen including autologous stem cell transplantation or

3. Other CD20 positive aggressive lymphoma for which an indication of allograft is selected (Burkitt lymphoma, lymphoblastic lymphoma, intra-vascular lymphoma…..) or

4. Low grade lymphoma CD20 positive (follicular lymphoma, marginal zone lymphoma) in histological processing or

5. 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 Criteria:

• 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