Cyclophosphamide and Busulfan as Conditioning Regimen Before Allogeneic HSCT

University Hospital, Basel, Switzerland72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Myeloid Leukemia Precursor Myeloid Neoplasms Lymphoid Neoplasms

Interventions

Busulfan-Cyclophosphamide as Conditioning Regimen before Allogeneic Hematopoietic Stem Cell TransplantationDRUG

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.

Cyclophosphamide-Busulfan as Conditioning Regimen before Allogeneic Hematopoietic Stem Cell TransplantationDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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 (3)

University Hospital, Basel

Basel, Switzerland

University Hospital Geneva

Geneva, Switzerland

University Hospital Zurich

Zurich, Switzerland

Outcomes

Primary Outcomes

Liver toxicity

Liver toxicity, assessed as absolute serum values of ASAT, ALAT, GGT, Alkaline Phosphatase, bilirubin at day 30.

Time frame: Day 30

Secondary Outcomes

VOD

Incidence and severity of "veno occlusive disease (VOD)" at day 30

Time frame: 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

Time frame: Day 30 and Day 100

Toxicity

Organ toxicity at day 30 and day 100

Time frame: Day 30 and Day 100

Efficacy

Survival, relapse and non-relapse mortality at day 30 and day 100

Time frame: 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

Time frame: 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

Time frame: Day 0, 10, 20 and 30

Data from ClinicalTrials.gov

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