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

NCT00607854 | Completed Phase 2 DMC

• 1 other identifier: CHUBX 2007/11
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 12

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 who are responsive to a salvage chemotherapy regimen.

Conditions

Diffuse Large B-Cell Lymphoma; Mantle Cell Lymphoma

Keywords

Zevalin; Reduced intensity conditioning; Allogenic stem cell transplantation

Outcome Measures

Primary Outcomes (1)

• the treatment-related mortality rate (except if the death is related to the lymphoma exclusively).

  day 100 post transplant

Secondary Outcomes (4)

• The event-free-survival (EFS)(an event is defined as: death from any cause, relapse or progression, need to another treatment except for donor-lymphocytes injection (DLI), patient lost for follow-up)

  1 year post transplant

• The rate of hematologic recovery (defined as ANC above 500/mm3 and platelets count above 20.000/mm3 for three consecutive days without stimulating growth support neither platelet transfusion)

  day 30

• Biological post allogenic effects of Zevalin® on the incidence of GVHD and B-cell and T-cell reconstitution

  days d0, d28, d90, d180 and 1 year

• Chimérism

  day d28, d56, d 80, 1 year than at least once a year

Study Arms (1)

Zevalin

EXPERIMENTAL

Zevalin associated with a Fludarabine-based reduced-intensity conditioning regimen,all patients will receive Zevalin in the conditioning regimen

Drug: Ibritumomab Tiuxetan (Zevalin)

Interventions

Ibritumomab Tiuxetan (Zevalin) DRUG

Conditioning regimen followed by allogeneic hematopoietic stem cell transplantation. Ibritumomab Tiuxetan(Zevalin): 0.4 mCi/kg IV at day -14 (Day 0 is the transplantation)

Zevalin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Bayer: collaborator

Study Sites (12)

Service d'hématologie - CHU de Besançon

Besançon, 25030, France

Location

Service des maladies du sang - Hôpital Haut-Lévêque - avenue de magellan

Bordeaux - Pessac, 33600, France

Location

Service d'hématologie - CHU Hôtel Dieu Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

Service de médecine nucléaire - Centre de Lutte contre le Cancer de la Région Auvergne Jean Perrin

Clermont-Ferrand, 63011, France

Location

Hôpital Edouard Herriot

Lyon, 69437, France

Location

Service d'Oncologie Hématologie, Institut Paoli Calmettes - 232 Bd Ste Marguerite

Marseille, 13009, France

Location

Hématologie et Oncologie médicale - CHU Lapeyronie

Montpellier, 34295, France

Location

Service d'Hématologie, Hôpital Hôtel Dieu, CHU Nantes - 1 Place Alexis Ricordeau

Nantes, 44093, France

Location

Service d'hématologie clinique - Hôpital l'Archet 1

Nice, 06202, France

Location

Service d'Hématologie Adultes - Hôpital Necker-Enfants Malade

Paris, 75015, France

Location

Pôle hématologie et immunologie clinique - Hôpital Saint-Louis

Paris, 75475, France

Location

Département d'hématologie et d'Oncologie - CHRU Hautepierre

Strasbourg, 67098, France

Location

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MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Lymphoma, Mantle-Cell

Interventions

ibritumomab tiuxetan

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Krimo BOUABDALLAH, MD

  University Hospital Bordeaux, France

  PRINCIPAL INVESTIGATOR

• Geneviève CHENE, Pr

  University Hospital Bordeaux, France

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2008
• First Posted: February 6, 2008
• Study Start: February 1, 2008
• Primary Completion: February 1, 2011
• Study Completion: November 1, 2011
• Last Updated: October 5, 2016

Record last verified: 2013-02

Locations

FR (12)