Clinical trial · Interventional
Cyclophosphamide and Busulfan as Conditioning Regimen Before Allogeneic HSCT
Cyclophosphamide-Busulfan Versus Busulfan-Cyclophosphamide as Conditioning Regimen Before Allogeneic Hematopoietic Stem Cell Transplantation for Leukemia: a Prospective Randomized Study to Assess Liver Toxicity
NCT01779882CI-TRIAL-00031896completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoid Neoplasms | Lymphoid Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Myeloid Leukemia | Myeloid Leukemia | ONTOLOGY_EXACT | 0.98 |
| Precursor Myeloid Neoplasms | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Busulfan-Cyclophosphamide as Conditioning Regimen before Allogeneic Hematopoietic Stem Cell Transplantation | Drug | — | UNRESOLVED |
| Cyclophosphamide-Busulfan as Conditioning Regimen before Allogeneic Hematopoietic Stem Cell Transplantation | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- BU-CY
- description
- Group A (standard group): conditioning regimen with Busulfan (BU) followed by Cyclophosphamide (CY)
- interventionNames
- Drug: Busulfan-Cyclophosphamide as Conditioning Regimen before Allogeneic Hematopoietic Stem Cell Transplantation
- type
- EXPERIMENTAL
- label
- CY-BU
- description
- Group B (experimental group): conditioning regimen with Cyclophosphamide (CY) followed by Busulfan (BU)
- interventionNames
- Drug: Cyclophosphamide-Busulfan as Conditioning Regimen before Allogeneic Hematopoietic Stem Cell Transplantation
Primary outcomes (1)
- measure
- Liver toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients planned to undergo an allogeneic HSCT with myeloablative conditioning * Age 18 - 65 years * Myeloid leukemia respectively related precursor neoplasms (acute myeloid leukemia, chronic myeloid leukemia, myelodysplastic syndrome), or lymphoid neoplasms (acute lymphoblastic leukemia/lymphoma, mature B-/T-/natural killer (NK)-cell neoplasms). * Human Leukocyte Antigen (HLA)-identical sibling donor or matched unrelated (min. 10/10 Ag matched) * Patients with a history of hepatitis might be included, if no contraindication for HSCT exists. * Patient must give written informed consent Exclusion Criteria: * Indication other than myeloid leukemia respectively related precursor neoplasms, or lymphoid neoplasms. * Severe liver damage for \> 2 weeks (bilirubin \> 3xupper limit normal (ULN) or ASAT/ALAT \> 5xULN) * HIV infection * Donor other than HLA-identical sibling or min. 10/10 matched unrelated donor * Pregnant or lactating women * Lack of written informed consent
References
Publications (2)
- BACKGROUNDCantoni 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. PMID 20548339
- DERIVEDSeydoux 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. PMID 37085674