| ID | Type | Description | Link |
|---|---|---|---|
| EBMT 42205525 |
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| Name | Class |
|---|---|
| Pierre Fabre Medicament | INDUSTRY |
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In this trial dose reduced conditioning is compared to standard conditioning followed by allogeneic stem cell transplantation from related or unrelated donors in patients with MDS or secondary AML.
Conditioning is the very high dose chemotherapy treatment that is given in the days before the stem cell transplant.
The hypothesis is that a dose reduced conditioning will reduce the non-relapse mortality from 40% to 20% at one year after allogeneic stem cell transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Myeloablative conditioning |
|
| B | Experimental | Reduced Intensity Conditioning |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reduced Intensity Conditioning | Other | Busilvex®: 6.4 mg/kg IBW i. v. day -7: 0.8 mg/kg IBW x 4 (2 hour infusion every 6 hours) day -6: 0.8 mg/kg IBW x 4 (2 hour infusion every 6 hours) or (if i.v.-application is not available) Busulfan: 8.0 mg/kg BW p. o.: day -7: 4.0 mg/kg BW day -6: 4.0 mg/kg BW plus: Fludarabine: 5 x 30 mg/m² BS i. v.: day -7: 30 mg/m² BS day -6: 30 mg/m² BS day -5: 30 mg/m² BS day -4: 30 mg/m² BS day -3: 30 mg/m² BS |
| Measure | Description | Time Frame |
|---|---|---|
| non-relapse mortality | every 6 months for safety and in the final analysis at one year after allogeneic stem cell transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| organ related toxicity of conditioning | every 6 months for safety and in the final analysis at day +30 after allogeneic stem cell transplantation | |
| Incidence of aGVHD | every 6 months for safety and in the final analysis at day +100 after allogeneic stem cell transplantation |
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Inclusion Criteria:
Disease: Cytologically proven primary or therapy-related myelodysplastic syndrome (MDS), either as
or secondary acute myeloid leukaemia (sAML).
Blast count < 20 percent in bone marrow with or without chemotherapy at time of transplantation.
Patient eligible for standard and dose-reduced conditioning as per local guideline.
Patient age 18 - 60 years if donor is a HLA-matched unrelated donor (HLA-A, HLA-B, HLA-DRB1 and HLA-DQB1) (one mismatch allowed):
Patient age 18 - 65 years if donor is a HLA-matched related donor ((HLA-A, HLA-B, HLA-DRB1 and HLA-DQB1) (one anti¬gen-mismatch allowed):
No major organ dysfunction.
Written informed consent of the patient.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicolaus Kröger, MD | Universitätsklinikum Hamburg-Eppendorf | Study Chair |
| Axel R Zander, MD | University Hospital Hamburg-Eppendorf, Germany | Principal Investigator |
| Ghulam J Mufti, MD | King's College Hospital London, United Kingdom | Principal Investigator |
| Marie Robin, MD | Hopital Saint-Louis Paris, France | Principal Investigator |
| Kathrin Haifa Al-Ali, MD | University Hospital Leipzig, Germany | Principal Investigator |
| Dietger Niederwieser, MD | University Hospital Leipzig, Germany | Principal Investigator |
| Giorgio Lambertenghi Deliliers | IRCCS Ospedale Maggiore of Milan, Italy | Principal Investigator |
| Domink Heim, Prof. | University Hospital, Basel, Switzerland | Principal Investigator |
| Liisa Volin, MD | Helsinki University Central Hospital, Finland |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Cologne | Germany | ||||
| University Hospital |
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| Label | URL |
|---|---|
| Related Info | View source |
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|
|
| Myeloablative conditioning | Other | Busilvex®: 12.8 mg/kg IBW i. v.; day -9: 0.8 mg/kg IBW x 4 (2 hour infusion every 6 hours) day -8: 0.8 mg/kg IBW x 4 (2 hour infusion every 6 hours) day -7: 0.8 mg/kg IBW x 4 (2 hour infusion every 6 hours) day -6: 0.8 mg/kg IBW x 4 (2 hour infusion every 6 hours) or (if i.v.-application is not available): Busulfan: 16.0 mg/kg BW p. o.; day -9: 4.0 mg/kg BW day -8: 4.0 mg/kg BW day -7: 4.0 mg/kg BW day -6: 4.0 mg/kg BW plus: Cyclophosphamide: 120 mg/kg BW i. v.; day -4: 60 mg/kg BW day -3: 60 mg/kg BW |
|
|
| incidence of cGVHD | every 6 months for safety and in the final analysis at one year after allogeneic stem cell transplantation |
| overall survival | every 6 months for safety and in the final analysis at 2 years after allogeneic stem cell transplantation |
| event-free survival | every 6 months for safety and in the final analysis at 2 years after allogeneic stem cell transplantation |
| cumulative incidence of relapse | every 6 months for safety and in the final analysis at 2 years after allogeneic stem cell transplantation |
| VOD | every 6 months for safety and in the final analysis at day +100 after allogeneic stem cell transplantation |
| infection incidence | every 6 months for safety and in the final analysis at day +100, 1 year and 2 years after allogeneic stem cell transplantation |
| Haematopoeitic recovery | every 6 months for safety and in the final analysis at day +30 after allogeneic stem cell transplantation |
| Stefano Guidi, MD | Careggi Hospital - Florence, Italy | Principal Investigator |
| Augustin Ferrant, MD | Cliniques Universitaires St. Luc Bruxelles, Belgium | Principal Investigator |
| Afanasyer Boris | SPB Pavlov Medical Univ, St. Petersburg, Russia | Principal Investigator |
| Kai Hubel | University of Cologne | Principal Investigator |
| Peter Dreger | Univ Hospital Heidelberg - Germany | Principal Investigator |
| Martin Gramatzlle | University Hospital Münster - Germany | Principal Investigator |
| Gerhard Behre | Martin-Luther-Universitaet Halle-Wittenberg - Germany | Principal Investigator |
| Martin Gramatzlle | Univ Hospital Kiel - Germany | Principal Investigator |
| Allione Bernardino | Santi Antonio E Biagio | Principal Investigator |
| Düsseldorf |
| Germany |
| Martin-Luther-Universität Halle-Wittenberg | Halle | Germany |
| University Hospital Eppendorf | Hamburg | Germany |
| University Hospital | Heidelberg | Germany |
| UKSH Campus Kiel | Kiel | Germany |
| University Hospital | Leipzig | Germany |
| Universitätsklinikum Munster | Münster | Germany |
| University Hospital | Tübingen | Germany |
| Santi Antonio e Biagio | Alessandria | Italy |
| Ospedale di Careggi | Florence | Italy |
| Ospedale Maggiore di Milano | Milan | Italy |
| Radboud University MC | Nijmegen | Netherlands |
| SPb State I. Pavlov Medical University | Saint Petersburg | Russia |
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D002066 | Busulfan |
| C042382 | fludarabine phosphate |
| D016465 | Bone Marrow Purging |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D008698 | Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D001781 | Blood Component Removal |
| D013812 | Therapeutics |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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