Cyclophosphamide-Busulfan Versus Busulfan-Cyclophosphamide as Conditioning Regimen Before Allogeneic Hematopoietic Stem Cell Transplantation for Leukemia: a Prospective Randomized Study to Assess Liver Toxicity
N/A
18 Years
65 Years
18 Years
65 Years
Open (Enrolling)
Both
Myeloid Leukemia, Precursor Myeloid Neoplasms, Lymphoid Neoplasms
Both
Myeloid Leukemia, Precursor Myeloid Neoplasms, Lymphoid Neoplasms
Trial Information
Cyclophosphamide-Busulfan Versus Busulfan-Cyclophosphamide as Conditioning Regimen Before Allogeneic Hematopoietic Stem Cell Transplantation for Leukemia: a Prospective Randomized Study to Assess Liver Toxicity
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-/NK-cell neoplasms).
- 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 > 3xULN 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Liver toxicity
Outcome Description:
Liver toxicity, assessed as absolute serum values of ASAT, ALAT, GGT, Alkaline Phosphatase, bilirubin at day 30.
Outcome Time Frame:
Day 30
Safety Issue:
Yes
Principal Investigator
Nathan Cantoni, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Kantonsspital Aarau, Switzerland
Authority:
Switzerland: Ethikkommission
Study ID:
BuCyBu study
NCT ID:
NCT01779882
Start Date:
January 2013
Completion Date:
Related Keywords:
- Myeloid Leukemia
- Precursor Myeloid Neoplasms
- Lymphoid Neoplasms
- Neoplasms
- Leukemia
- Leukemia, Myeloid
- Lymphoma
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