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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-004517-34 | EudraCT Number |
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Target variables:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Group I: Relapsed AML-patients with blast cell reduction to <20% before the second course of induction therapy. These patients will receive conventional SCT. Group II: Patients with non response to frontline treatment of AML, patients with blast cells <20% before the second course of induction therapy who do not achieve a second remission and relapsed AML-patients with blast cells >=20% before the second course of induction therapy. If these patients have a matched donor (MSD/MD) they will receive SCT with "FLAMSA". Group III: Patients who are eligible for Group II but have no matched donor. These patients will receive SCT from a haploidentical donor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hematopoietic stem cells from bone marrow or peripheral blood | Biological | > = 2 x 10*8 nucleated cells (WBC)/kg body weight of the recipient or rather > = 4 x 10*6 nucleated CD34+ cells / kg body weight are required for engraftment. Suspension of stem cells is administered via intravenous infusion. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate whether stem cell transplantation (SCT) from a matched sibling donor (MSD) is equivalent to a matched unrelated donor (MUD) in second complete remission (CR2). | day 100 | |
| To evaluate whether "FLAMSA" increases leukemia free survival (LFS) and overall survival (OS) as compared to a historic control group | day 100 | |
| To evaluate whether SCT from haploidentical donors for children having no matched donor will result in an acceptable toxicity profile and a better LFS as compared to historic controls. | day 100 |
| Measure | Description | Time Frame |
|---|---|---|
| Prospective evaluation of event free survival (EFS), LFS, and OS after SCT from either a MSD or a MUD | day 100 | |
| To evaluate whether it is feasible to standardize transplantation procedures in children with AML within the AML-Berlin/Frankfurt/Münster (BFM) study network |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Sauer, Prof. Dr. | Hannover Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Graz University Hospital | Graz | 8036 | Austria | |||
| Innsbruck University Hospital |
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|
| day 100 |
| Decrease of transplantation associated mortality by standardized donor selection criteria | day 100 |
| To further evaluate the contribution of immunomediated effects for the treatment of children suffering from very high risk AML | day 100 |
| Prospective evaluation of late toxicities | day 100 and year 5 |
| Innsbruck |
| 6020 |
| Austria |
| St. Anna Children Hospital | Vienna | 1090 | Austria |
| Teaching Hospital Motol | Prague | 15006 | Czechia |
| University Hospital Freiburg | Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany |
| Heidelberg University Hospital | Heidelberg | Baden-Wurttemberg | 69120 | Germany |
| University Children's Hospital Tübingen | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| University Children's Hospital Ulm | Ulm | Baden-Wurttemberg | 89075 | Germany |
| University Children's Hospital Erlangen-Nürnberg | Erlangen | Bavaria | 91054 | Germany |
| Dr. von Haunersches Kinderspital | München | Bavaria | 80337 | Germany |
| University Hospital Würzburg | Würzburg | Bavaria | 97080 | Germany |
| J.W. Goethe University Hospital and Faculty of Medicine | Frankfurt am Main | Hesse | 60590 | Germany |
| Gießen University Hospital | Giessen | Hesse | 35385 | Germany |
| Hannover Medical School, Department of Paediatrics, Paediatric Hematology and Oncology | Hanover | Lower Saxony | 30625 | Germany |
| University Hospital Greifswald | Greifswald | Mecklenburg-West Pomerania | 17475 | Germany |
| Düsseldorf University Hospital | Düsseldorf | North Rhine-Westphalia | 40225 | Germany |
| University Hospital Essen | Essen | North Rhine-Westphalia | 45122 | Germany |
| Münster University Hospital | Münster | North Rhine-Westphalia | 48149 | Germany |
| Carl Gustav Carus University Children's Hospital Dresden | Dresden | Saxony | 01307 | Germany |
| University Children's Hospital Halle | Halle | Saxony-Anhalt | 06097 | Germany |
| University Hospital Kiel | Kiel | Schleswig-Holstein | 24105 | Germany |
| University Children's Hospital Jena | Jena | Thuringia | 07724 | Germany |
| Charité Campus Rudolf Virchow Hospital | Berlin | 13353 | Germany |
| Hamburg-Eppendorf University Hospital | Hamburg | 20246 | Germany |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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