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NCT Number: NCT01779882

Cyclophosphamide and Busulfan as Conditioning Regimen Before Allogeneic HSCT

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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Key information

Conditions

Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Lymphoid Neoplasms Neoplasms Neoplasms by Histologic Type Precursor Myeloid Neoplasms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, Basel, Basel, Switzerland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Liver toxicity

    Time frame: Day 30

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

Secondary outcomes

  1. VOD

    Time frame: Day 30

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

  2. Acute graft-versus-host disease (GvHD)

    Time frame: Day 30 and Day 100

    Incidence and severity of acute GVHD, by organ (skin, liver, gut) at day 30 and day 100

  3. Toxicity

    Time frame: Day 30 and Day 100

    Organ toxicity at day 30 and day 100

  4. Efficacy

    Time frame: Day 30 and Day 100

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

  5. Cumulative liver values

    Time frame: Day 0, 10, 20 and 30

    Cumulative serum values of aspartate transaminase (ASAT), alanine aminotransferase (ALAT), gamma-glutamyltransferase (GGT), Alkaline Phosphatase, bilirubin for days 0, 10, 20 and 30

  6. Maximum liver values

    Time frame: Day 0, 10, 20 and 30

    Maximum serum values of ASAT, ALAT, GGT, alkaline phosphatase (AP), bilirubin at any time between day 0 and day 30

Other outcomes

  1. Cytokines measurement

    Time frame: Day -8, 0, 10, 20 and 30

    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.

  2. Pharmacogenomics

    Time frame: Day -8, -3 and 0

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • University Hospital, Geneva
  • University Hospital, Zürich

Registry information

Official study title

Cyclophosphamide-Busulfan Versus Busulfan-Cyclophosphamide as Conditioning Regimen Before Allogeneic Hematopoietic Stem Cell Transplantation for Leukemia: a Prospective Randomized Study to Assess Liver Toxicity

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Jan 30, 2013
Registry last updated
Mar 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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