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| Name | Class |
|---|---|
| University Hospital, Zürich | OTHER |
| University Hospital, Geneva | OTHER |
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The aim of this study is to test the hypothesis, that the order of application of Busulfan (BU) and Cyclophosphamide (CY) has an impact on toxicity after allogeneic Hematopoietic stem cell transplantation (HSCT) and that CY-BU reduces liver toxicity compared to BU-CY.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BU-CY | Active Comparator | Group A (standard group): conditioning regimen with Busulfan (BU) followed by Cyclophosphamide (CY) |
|
| CY-BU | Experimental | Group B (experimental group): conditioning regimen with Cyclophosphamide (CY) followed by Busulfan (BU) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Busulfan-Cyclophosphamide as Conditioning Regimen before Allogeneic Hematopoietic Stem Cell Transplantation | Drug | Test the hypothesis, that the order of application of Busulfan (BU) and Cyclophosphamide (CY) has an impact on toxicity after allogeneic Hematopoietic stem cell transplantation (HSCT) and that CY-BU reduces liver toxicity compared to BU-CY. |
| Measure | Description | Time Frame |
|---|---|---|
| Liver toxicity | Liver toxicity, assessed as absolute serum values of ASAT, ALAT, GGT, Alkaline Phosphatase, bilirubin at day 30. | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| VOD | Incidence and severity of "veno occlusive disease (VOD)" at day 30 | Day 30 |
| Acute graft-versus-host disease (GvHD) | Incidence and severity of acute GVHD, by organ (skin, liver, gut) at day 30 and day 100 |
| Measure | Description | Time Frame |
|---|---|---|
| Cytokines measurement | To test the correlation between order of application of the conditioning regimen and the levels of proinflammatory cytokines as well as the correlation between levels of cytokines and development of acute GVHD, plasma samples will be collected at different time points. | Day -8, 0, 10, 20 and 30 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nathan Cantoni, MD | Kantonsspital Aarau, Switzerland | Study Chair |
| Sabine Gerull, MD | University Hospital, Basel, Switzerland | Principal Investigator |
| Gayathri Nair, MD | University Hospital, Zürich | Principal Investigator |
| Yves Chalandon, MD | University Hospital Geneva, Switzerland | Principal Investigator |
| Jakob Passweg, MD | University Hospital, Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, Basel | Basel | 4031 | Switzerland | |||
| University Hospital Geneva |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20548339 | Background | Cantoni N, Gerull S, Heim D, Halter J, Bucher C, Buser A, Tsakiris DA, Passweg J, Tichelli A, Stern M, Gratwohl A. Order of application and liver toxicity in patients given BU and CY containing conditioning regimens for allogeneic hematopoietic SCT. Bone Marrow Transplant. 2011 Mar;46(3):344-9. doi: 10.1038/bmt.2010.137. Epub 2010 Jun 14. | |
| 37085674 |
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|
| Cyclophosphamide-Busulfan as Conditioning Regimen before Allogeneic Hematopoietic Stem Cell Transplantation | Drug | Test the hypothesis, that the order of application of Busulfan (BU) and Cyclophosphamide (CY) has an impact on toxicity after allogeneic Hematopoietic stem cell transplantation (HSCT) and that CY-BU reduces liver toxicity compared to BU-CY. |
|
| Day 30 and Day 100 |
| Toxicity | Organ toxicity at day 30 and day 100 | Day 30 and Day 100 |
| Efficacy | Survival, relapse and non-relapse mortality at day 30 and day 100 | Day 30 and Day 100 |
| Cumulative liver values | Cumulative serum values of aspartate transaminase (ASAT), alanine aminotransferase (ALAT), gamma-glutamyltransferase (GGT), Alkaline Phosphatase, bilirubin for days 0, 10, 20 and 30 | Day 0, 10, 20 and 30 |
| Maximum liver values | Maximum serum values of ASAT, ALAT, GGT, alkaline phosphatase (AP), bilirubin at any time between day 0 and day 30 | Day 0, 10, 20 and 30 |
| Pharmacogenomics |
The current hypothesis is that some functional polymorphisms of genes, which control important enzymes in BU and CY metabolism, contribute to the observed interindividual variability in toxicity after allogeneic HSCT. |
| Day -8, -3 and 0 |
| Geneva |
| 1205 |
| Switzerland |
| University Hospital Zurich | Zurich | 8091 | Switzerland |
| Seydoux C, Uppugunduri CRS, Medinger M, Nava T, Halter J, Heim D, Chalandon Y, Schanz U, Nair G, Cantoni N, Passweg JR, Ansari M. Effect of pharmacokinetics and pharmacogenomics in adults with allogeneic hematopoietic cell transplantation conditioned with Busulfan. Bone Marrow Transplant. 2023 Jul;58(7):811-816. doi: 10.1038/s41409-023-01963-z. Epub 2023 Apr 21. |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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