Cyclophosphamide and Busulfan as Conditioning Regimen Before Allogeneic HSCT

NCT ID: NCT01779882

Last Updated: 2018-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2018-01-06

Brief 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.

Conditions

Myeloid Leukemia; Precursor Myeloid Neoplasms; Lymphoid Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BU-CY

Group A (standard group): conditioning regimen with Busulfan (BU) followed by Cyclophosphamide (CY)

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

CY-BU

Group B (experimental group): conditioning regimen with Cyclophosphamide (CY) followed by Busulfan (BU)

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: DRUG

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

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Zürich

OTHER

Sponsor Role: collaborator

University Hospital, Geneva

OTHER

Sponsor Role: collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nathan Cantoni, MD

Role: STUDY_CHAIR

Kantonsspital Aarau, Switzerland

Sabine Gerull, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Gayathri Nair, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Zürich

Yves Chalandon, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Geneva, Switzerland

Jakob Passweg, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

University Hospital, Basel

Basel, , Switzerland

University Hospital Geneva

Geneva, , Switzerland

University Hospital Zurich

Zurich, , Switzerland

Countries

Switzerland

References

Cantoni 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.

Reference Type: BACKGROUND

PMID: 20548339 (View on PubMed)

Seydoux 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.

Reference Type: DERIVED

PMID: 37085674 (View on PubMed)

Other Identifiers

BuCyBu study

Identifier Type: -

Identifier Source: org_study_id