Diffuse Large B-Cell LymphomaPhase 2ZEVALLONCT00607854
Safety of Ibritumomab Tiuxetan (Zevalin®) in Combination With a Fludarabine-based Reduced Intensity Conditioning (RIC) Regimen (ZEVALLO 2007)
A Phase 2 study testing Ibritumomab Tiuxetan (Zevalin) in people with Diffuse Large B-Cell Lymphoma and Mantle Cell Lymphoma, run by University Hospital, Bordeaux at 12 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma
- What is being tested?
- Ibritumomab Tiuxetan (Zevalin)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 12 sitesFrance
- Study dates
- Feb 2008to Nov 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- 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:
Show all 12Show fewer
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Service d'hématologie - CHU de Besançon
Besançon, 25030
Service des maladies du sang - Hôpital Haut-Lévêque - avenue de magellan
Bordeaux - Pessac, 33600
Service d'hématologie - CHU Hôtel Dieu Clermont-Ferrand
Clermont-Ferrand, 63000
Service de médecine nucléaire - Centre de Lutte contre le Cancer de la Région Auvergne Jean Perrin
Clermont-Ferrand, 63011
Hôpital Edouard Herriot
Lyon, 69437
Service d'Oncologie Hématologie, Institut Paoli Calmettes - 232 Bd Ste Marguerite
Marseille, 13009
Hématologie et Oncologie médicale - CHU Lapeyronie
Montpellier, 34295
Service d'Hématologie, Hôpital Hôtel Dieu, CHU Nantes - 1 Place Alexis Ricordeau
Nantes, 44093
Service d'hématologie clinique - Hôpital l'Archet 1
Nice, 06202
Service d'Hématologie Adultes - Hôpital Necker-Enfants Malade
Paris, 75015
Pôle hématologie et immunologie clinique - Hôpital Saint-Louis
Paris, 75475
Département d'hématologie et d'Oncologie - CHRU Hautepierre
Strasbourg, 67098
About this study
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.
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.
Read the 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, …).
- Being tested
- Ibritumomab Tiuxetan (Zevalin)
- Keywords
- Zevalin, Reduced intensity conditioning, Allogenic stem cell transplantation
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| Zevalin | Experimental | Zevalin associated with a Fludarabine-based reduced-intensity conditioning regimen,all patients will receive Zevalin in the conditioning regimen Receives: Drug: Ibritumomab Tiuxetan (Zevalin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the treatment-related mortality rate (except if the death is related to the lymphoma exclusively).
Measured: 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)
Measured: 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)
Measured: day 30
Biological post allogenic effects of Zevalin® on the incidence of GVHD and B-cell and T-cell reconstitution
Measured: days d0, d28, d90, d180 and 1 year
Chimérism
Measured: day d28, d56, d 80, 1 year than at least once a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionFeb 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Diffuse Large B-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Krimo BOUABDALLAH, MD, Principal investigator, University Hospital Bordeaux, FranceGeneviève CHENE, Pr, Study chair, University Hospital Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00607854
- Sponsor's protocol ID
- CHUBX 2007/11
- Acronym
- ZEVALLO
- Status last verified
- Feb 2013
- First submitted
- 23 Jan 2008
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cheson BD. The role of radioimmunotherapy with yttrium-90 ibritumomab tiuxetan in the treatment of non-Hodgkin lymphoma. BioDrugs. 2005;19(5):309-22. doi: 10.2165/00063030-200519050-00004.
PubMed 16207072Chopra R, Goldstone AH, Pearce R, Philip T, Petersen F, Appelbaum F, De Vol E, Ernst P. Autologous versus allogeneic bone marrow transplantation for non-Hodgkin's lymphoma: a case-controlled analysis of the European Bone Marrow Transplant Group Registry data. J Clin Oncol. 1992 Nov;10(11):1690-5. doi: 10.1200/JCO.1992.10.11.1690.
PubMed 1403052Dean RM, Fowler DH, Wilson WH, Odom J, Steinberg SM, Chow C, Kasten-Sportes C, Gress RE, Bishop MR. Efficacy of reduced-intensity allogeneic stem cell transplantation in chemotherapy-refractory non-hodgkin lymphoma. Biol Blood Marrow Transplant. 2005 Aug;11(8):593-9. doi: 10.1016/j.bbmt.2005.04.005.
PubMed 16041309Escalon MP, Champlin RE, Saliba RM, Acholonu SA, Hosing C, Fayad L, Giralt S, Ueno NT, Maadani F, Pro B, Donato M, McLaughlin P, Khouri IF. Nonmyeloablative allogeneic hematopoietic transplantation: a promising salvage therapy for patients with non-Hodgkin's lymphoma whose disease has failed a prior autologous transplantation. J Clin Oncol. 2004 Jun 15;22(12):2419-23. doi: 10.1200/JCO.2004.09.092.
PubMed 15197204Fietz T, Uharek L, Gentilini C, Muessig A, Rieger K, Marinets O, Sandrock D, Munz DL, Glass B, Thiel E, Blau IW. Allogeneic hematopoietic cell transplantation following conditioning with 90Y-ibritumomab-tiuxetan. Leuk Lymphoma. 2006 Jan;47(1):59-63. doi: 10.1080/10428190500260478.
PubMed 16321828Frater JL, Hsi ED. Properties of the mantle cell and mantle cell lymphoma. Curr Opin Hematol. 2002 Jan;9(1):56-62. doi: 10.1097/00062752-200201000-00010.
PubMed 11753079Freytes CO, Loberiza FR, Rizzo JD, Bashey A, Bredeson CN, Cairo MS, Gale RP, Horowitz MM, Klumpp TR, Martino R, McCarthy PL, Molina A, Pavlovsky S, Pecora AL, Serna DS, Tsai T, Zhang MJ, Vose JM, Lazarus HM, van Besien K; Lymphoma Working Committee of the International Bone Marrow Transplant Registry. Myeloablative allogeneic hematopoietic stem cell transplantation in patients who experience relapse after autologous stem cell transplantation for lymphoma: a report of the International Bone Marrow Transplant Registry. Blood. 2004 Dec 1;104(12):3797-803. doi: 10.1182/blood-2004-01-0231. Epub 2004 Jul 27.
PubMed 15280203Gianni AM, Cortelazzo S, Magni M, Martelli M; Michelangelo Cooperative. Rituximab: enhancing stem cell transplantation in mantle cell lymphoma. Bone Marrow Transplant. 2002 Feb;29 Suppl 1:S10-3. doi: 10.1038/sj.bmt.1703296.
PubMed 11840155Gopal AK, Pagel JM, Rajendran JG, Maloney DG, Appelbaum FR, Sorror ML, Sandmaier BM, Storb R, Press OW. Improving the efficacy of reduced intensity allogeneic transplantation for lymphoma using radioimmunotherapy. Biol Blood Marrow Transplant. 2006 Jul;12(7):697-702. doi: 10.1016/j.bbmt.2006.03.014.
PubMed 16785058Grigg A, Ritchie D. Graft-versus-lymphoma effects: clinical review, policy proposals, and immunobiology. Biol Blood Marrow Transplant. 2004 Sep;10(9):579-90. doi: 10.1016/j.bbmt.2004.05.008.
PubMed 15319770Haioun C, Lepage E, Gisselbrecht C, Salles G, Coiffier B, Brice P, Bosly A, Morel P, Nouvel C, Tilly H, Lederlin P, Sebban C, Briere J, Gaulard P, Reyes F. Survival benefit of high-dose therapy in poor-risk aggressive non-Hodgkin's lymphoma: final analysis of the prospective LNH87-2 protocol--a groupe d'Etude des lymphomes de l'Adulte study. J Clin Oncol. 2000 Aug;18(16):3025-30. doi: 10.1200/JCO.2000.18.16.3025.
PubMed 10944137Johnson TA, Press OW. Synergistic cytotoxicity of iodine-131-anti-CD20 monoclonal antibodies and chemotherapy for treatment of B-cell lymphomas. Int J Cancer. 2000 Jan 1;85(1):104-12. doi: 10.1002/(sici)1097-0215(20000101)85:13.0.co;2-g.
PubMed 10585592Jones RJ, Ambinder RF, Piantadosi S, Santos GW. Evidence of a graft-versus-lymphoma effect associated with allogeneic bone marrow transplantation. Blood. 1991 Feb 1;77(3):649-53.
PubMed 1991174Khouri IF, Keating M, Korbling M, Przepiorka D, Anderlini P, O'Brien S, Giralt S, Ippoliti C, von Wolff B, Gajewski J, Donato M, Claxton D, Ueno N, Andersson B, Gee A, Champlin R. Transplant-lite: induction of graft-versus-malignancy using fludarabine-based nonablative chemotherapy and allogeneic blood progenitor-cell transplantation as treatment for lymphoid malignancies. J Clin Oncol. 1998 Aug;16(8):2817-24. doi: 10.1200/JCO.1998.16.8.2817.
PubMed 9704734Khouri IF, Lee MS, Romaguera J, Mirza N, Kantarjian H, Korbling M, Albitar M, Giralt S, Samuels B, Anderlini P, Rodriguez J, von Wolff B, Gajewski J, Cabanillas F, Champlin R. Allogeneic hematopoietic transplantation for mantle-cell lymphoma: molecular remissions and evidence of graft-versus-malignancy. Ann Oncol. 1999 Nov;10(11):1293-9. doi: 10.1023/a:1008380527502.
PubMed 10631455
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00607854
- Acronym / sponsor ID
- ZEVALLO / CHUBX 2007/11
- Keywords
- Zevalin, Reduced intensity conditioning, Allogenic stem cell transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Feb 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 6 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, …).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zevalin | Experimental | Drug: Ibritumomab Tiuxetan (Zevalin)Zevalin associated with a Fludarabine-based reduced-intensity conditioning regimen,all patients will receive Zevalin in the conditioning regimen |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age ≥ 18 and ≤ 65
- Patients with this lymphoma:
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ibritumomab Tiuxetan (Zevalin)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) | Drug | Zevalin |
Primary outcome
the treatment-related mortality rate (except if the death is related to the lymphoma exclusively).
Time frame: day 100 post transplant
4 secondary outcomes
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
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
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
Chimérism
Time frame: day d28, d56, d 80, 1 year than at least once a year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2016.
- Background: PubMed 16207072Cheson BD. The role of radioimmunotherapy with yttrium-90 ibritumomab tiuxetan in the treatment of non-Hodgkin lymphoma. BioDrugs. 2005;19(5):309-22. doi: 10.2165/00063030-200519050-00004.
- Background: PubMed 1403052Chopra R, Goldstone AH, Pearce R, Philip T, Petersen F, Appelbaum F, De Vol E, Ernst P. Autologous versus allogeneic bone marrow transplantation for non-Hodgkin's lymphoma: a case-controlled analysis of the European Bone Marrow Transplant Group Registry data. J Clin Oncol. 1992 Nov;10(11):1690-5. doi: 10.1200/JCO.1992.10.11.1690.
- Background: PubMed 16041309Dean RM, Fowler DH, Wilson WH, Odom J, Steinberg SM, Chow C, Kasten-Sportes C, Gress RE, Bishop MR. Efficacy of reduced-intensity allogeneic stem cell transplantation in chemotherapy-refractory non-hodgkin lymphoma. Biol Blood Marrow Transplant. 2005 Aug;11(8):593-9. doi: 10.1016/j.bbmt.2005.04.005.
- Background: PubMed 15197204Escalon MP, Champlin RE, Saliba RM, Acholonu SA, Hosing C, Fayad L, Giralt S, Ueno NT, Maadani F, Pro B, Donato M, McLaughlin P, Khouri IF. Nonmyeloablative allogeneic hematopoietic transplantation: a promising salvage therapy for patients with non-Hodgkin's lymphoma whose disease has failed a prior autologous transplantation. J Clin Oncol. 2004 Jun 15;22(12):2419-23. doi: 10.1200/JCO.2004.09.092.
- Background: PubMed 16321828Fietz T, Uharek L, Gentilini C, Muessig A, Rieger K, Marinets O, Sandrock D, Munz DL, Glass B, Thiel E, Blau IW. Allogeneic hematopoietic cell transplantation following conditioning with 90Y-ibritumomab-tiuxetan. Leuk Lymphoma. 2006 Jan;47(1):59-63. doi: 10.1080/10428190500260478.
- Background: PubMed 11753079Frater JL, Hsi ED. Properties of the mantle cell and mantle cell lymphoma. Curr Opin Hematol. 2002 Jan;9(1):56-62. doi: 10.1097/00062752-200201000-00010.
- Background: PubMed 15280203Freytes CO, Loberiza FR, Rizzo JD, Bashey A, Bredeson CN, Cairo MS, Gale RP, Horowitz MM, Klumpp TR, Martino R, McCarthy PL, Molina A, Pavlovsky S, Pecora AL, Serna DS, Tsai T, Zhang MJ, Vose JM, Lazarus HM, van Besien K; Lymphoma Working Committee of the International Bone Marrow Transplant Registry. Myeloablative allogeneic hematopoietic stem cell transplantation in patients who experience relapse after autologous stem cell transplantation for lymphoma: a report of the International Bone Marrow Transplant Registry. Blood. 2004 Dec 1;104(12):3797-803. doi: 10.1182/blood-2004-01-0231. Epub 2004 Jul 27.
- Background: PubMed 11840155Gianni AM, Cortelazzo S, Magni M, Martelli M; Michelangelo Cooperative. Rituximab: enhancing stem cell transplantation in mantle cell lymphoma. Bone Marrow Transplant. 2002 Feb;29 Suppl 1:S10-3. doi: 10.1038/sj.bmt.1703296.
- Background: PubMed 16785058Gopal AK, Pagel JM, Rajendran JG, Maloney DG, Appelbaum FR, Sorror ML, Sandmaier BM, Storb R, Press OW. Improving the efficacy of reduced intensity allogeneic transplantation for lymphoma using radioimmunotherapy. Biol Blood Marrow Transplant. 2006 Jul;12(7):697-702. doi: 10.1016/j.bbmt.2006.03.014.
- Background: PubMed 15319770Grigg A, Ritchie D. Graft-versus-lymphoma effects: clinical review, policy proposals, and immunobiology. Biol Blood Marrow Transplant. 2004 Sep;10(9):579-90. doi: 10.1016/j.bbmt.2004.05.008.
- Background: PubMed 10944137Haioun C, Lepage E, Gisselbrecht C, Salles G, Coiffier B, Brice P, Bosly A, Morel P, Nouvel C, Tilly H, Lederlin P, Sebban C, Briere J, Gaulard P, Reyes F. Survival benefit of high-dose therapy in poor-risk aggressive non-Hodgkin's lymphoma: final analysis of the prospective LNH87-2 protocol--a groupe d'Etude des lymphomes de l'Adulte study. J Clin Oncol. 2000 Aug;18(16):3025-30. doi: 10.1200/JCO.2000.18.16.3025.
- Background: PubMed 10585592Johnson TA, Press OW. Synergistic cytotoxicity of iodine-131-anti-CD20 monoclonal antibodies and chemotherapy for treatment of B-cell lymphomas. Int J Cancer. 2000 Jan 1;85(1):104-12. doi: 10.1002/(sici)1097-0215(20000101)85:13.0.co;2-g.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krimo BOUABDALLAH, MD principal investigator
University Hospital Bordeaux, France
Geneviève CHENE, Pr study chair
University Hospital Bordeaux, France
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ibritumomab Tiuxetan (Zevalin) in people with Diffuse Large B-Cell Lymphoma and Mantle Cell Lymphoma, run by University Hospital, Bordeaux at 12 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the treatment-related mortality rate (except if the death is related to the lymphoma exclusively). (time frame: day 100 post transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00607854, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2016.