Back to resultsSafety of Ibritumomab Tiuxetan (Zevalin®) in Combination With a Fludarabine-based Reduced Intensity Conditioning (RIC) Regimen (ZEVALLO 2007) (ZEVALLO)
Primary Purpose
Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Ibritumomab Tiuxetan (Zevalin)
Sponsored by
About this trial
This is an interventional treatment trial for Diffuse Large B-Cell Lymphoma focused on measuring Zevalin, Reduced intensity conditioning, Allogenic stem cell transplantation
Eligibility Criteria
Inclusion Criteria:
- 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 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
Sites / Locations
- Service d'hématologie - CHU de Besançon
- Service des maladies du sang - Hôpital Haut-Lévêque - avenue de magellan
- Service d'hématologie - CHU Hôtel Dieu Clermont-Ferrand
- Service de médecine nucléaire - Centre de Lutte contre le Cancer de la Région Auvergne Jean Perrin
- Hôpital Edouard Herriot
- Service d'Oncologie Hématologie, Institut Paoli Calmettes - 232 Bd Ste Marguerite
- Hématologie et Oncologie médicale - CHU Lapeyronie
- Service d'Hématologie, Hôpital Hôtel Dieu, CHU Nantes - 1 Place Alexis Ricordeau
- Service d'hématologie clinique - Hôpital l'Archet 1
- Service d'Hématologie Adultes - Hôpital Necker-Enfants Malade
- Pôle hématologie et immunologie clinique - Hôpital Saint-Louis
- Département d'hématologie et d'Oncologie - CHRU Hautepierre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Zevalin
Arm Description
Zevalin associated with a Fludarabine-based reduced-intensity conditioning regimen,all patients will receive Zevalin in the conditioning regimen
Outcomes
Primary Outcome Measures
the treatment-related mortality rate (except if the death is related to the lymphoma exclusively).
Secondary Outcome Measures
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)
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)
Biological post allogenic effects of Zevalin® on the incidence of GVHD and B-cell and T-cell reconstitution
Chimérism
Full Information
NCT ID
NCT00607854
First Posted
January 23, 2008
Last Updated
October 4, 2016
Sponsor
University Hospital, Bordeaux
Collaborators
Bayer
1. Study Identification
Unique Protocol Identification Number
NCT00607854
Brief Title
Safety of Ibritumomab Tiuxetan (Zevalin®) in Combination With a Fludarabine-based Reduced Intensity Conditioning (RIC) Regimen (ZEVALLO 2007)
Acronym
ZEVALLO
Official Title
Safety and Efficacy of Ibritumomab Tiuxetan (Zevalin®) in Association With a Fludarabine Based Reduced Conditioning Regimen and Allogenic Stem Cell Support in Chemo-sensitive Relapsed CD20 Positive Aggressive Non-Hodgkin's Lymphoma Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
Collaborators
Bayer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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 been already evaluated in the setting of allo-SCT and the results reported so far seem to be promising without an overwhelming toxicity neither a delayed hematologic recovery. The assumption that the addition of Zevalin® to the conditioning regimen might improve lymphoma control and the demonstration that nucleoside analogs such as fludarabine synergize optimally with RIT led us to conduct this trial using the following preparative regimen: rituximab 250 mg/m² on days -21 and -14, Zevalin® 0,4 mCi/Kg body weight on day -14, fludarabine 30 mg/m² intravenously from days -6 to -2, Busulfan orally (4 mg/Kg body weight) or intravenously (0,8 mg/Kg body weight) on days -5 and -4 and ATG (Thymoglobulin®) 2,5 mg/Kg body weight intravenously on day -1. Cyclosporine A is administered at 2 or 3 mg/Kg body weight from day -1 to day 28 than followed by a dose reduction.
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
Patients are followed from the beginning of the RIC regimen until day 365 for primary and secondary objectives of the study than on a regular basis depending on the practice of each centre. The evaluation includes physical examination (performance status, hematologic assessment, acute and chronic GVH disease), biologic tests (blood screening for blood count, renal and hepatic function, B and T-cell recovery, chimerism analysis, response assessment) and complementary examinations (marrow biopsies, tomography scan, positron emission tomography, …).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma
Keywords
Zevalin, Reduced intensity conditioning, Allogenic stem cell transplantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Zevalin
Arm Type
Experimental
Arm Description
Zevalin associated with a Fludarabine-based reduced-intensity conditioning regimen,all patients will receive Zevalin in the conditioning regimen
Intervention Type
Drug
Intervention Name(s)
Ibritumomab Tiuxetan (Zevalin)
Intervention Description
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)
Primary Outcome Measure Information:
Title
the treatment-related mortality rate (except if the death is related to the lymphoma exclusively).
Time Frame
day 100 post transplant
Secondary Outcome Measure Information:
Title
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)
Time Frame
1 year post transplant
Title
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)
Time Frame
day 30
Title
Biological post allogenic effects of Zevalin® on the incidence of GVHD and B-cell and T-cell reconstitution
Time Frame
days d0, d28, d90, d180 and 1 year
Title
Chimérism
Time Frame
day d28, d56, d 80, 1 year than at least once a year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Krimo BOUABDALLAH, MD
Organizational Affiliation
University Hospital Bordeaux, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Geneviève CHENE, Pr
Organizational Affiliation
University Hospital Bordeaux, France
Official's Role
Study Chair
Facility Information:
Facility Name
Service d'hématologie - CHU de Besançon
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
Service des maladies du sang - Hôpital Haut-Lévêque - avenue de magellan
City
Bordeaux - Pessac
ZIP/Postal Code
33600
Country
France
Facility Name
Service d'hématologie - CHU Hôtel Dieu Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Service de médecine nucléaire - Centre de Lutte contre le Cancer de la Région Auvergne Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
Hôpital Edouard Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
Service d'Oncologie Hématologie, Institut Paoli Calmettes - 232 Bd Ste Marguerite
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Hématologie et Oncologie médicale - CHU Lapeyronie
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Service d'Hématologie, Hôpital Hôtel Dieu, CHU Nantes - 1 Place Alexis Ricordeau
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Service d'hématologie clinique - Hôpital l'Archet 1
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Service d'Hématologie Adultes - Hôpital Necker-Enfants Malade
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Pôle hématologie et immunologie clinique - Hôpital Saint-Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Département d'hématologie et d'Oncologie - CHRU Hautepierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France
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Safety of Ibritumomab Tiuxetan (Zevalin®) in Combination With a Fludarabine-based Reduced Intensity Conditioning (RIC) Regimen (ZEVALLO 2007)
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