Cyclophosphamide and Busulfan as Conditioning Regimen Before Allogeneic HSCT
Conditions
Myeloid Leukemia - Precursor Myeloid Neoplasms - Lymphoid Neoplasms
Conditions: official terms
Neoplasms
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Busulfan-Cyclophosphamide as Conditioning Regimen before Allogeneic Hematopoietic Stem Cell Transplantation Type: Drug
Name: Cyclophosphamide-Busulfan as Conditioning Regimen before Allogeneic Hematopoietic Stem Cell Transplantation Type: Drug
Overall Status
Recruiting
Summary
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 65 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Locations
University Hospital, Basel
Basel, Switzerland
Status: Recruiting
University Hospital Geneva
Geneva, Switzerland
Status: Recruiting
Contact: Yves Chalandon, MD
University Hospital Zurich
Zurich, Switzerland
Status: Recruiting
Contact: Gayathri Nair, MD - +41442551111 - gayathri.nair@usz.ch
Start Date
January 2013
Sponsors
University Hospital, Basel, Switzerland
Source
University Hospital, Basel, Switzerland
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page