Cyclophosphamide and Busulfan as Conditioning Regimen Before Allogeneic HSCT

Not Applicable

Completed

• Conditions: Myeloid Leukemia; Precursor Myeloid Neoplasms; Lymphoid Neoplasms
• Interventions: Drug: Busulfan-Cyclophosphamide as Conditioning Regimen before Allogeneic Hematopoietic Stem Cell Transplantation; Drug: Cyclophosphamide-Busulfan as Conditioning Regimen before Allogeneic Hematopoietic Stem Cell Transplantation

• Registration Number: NCT01779882
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-28
• Study First Submitted QC: 2013-01-28
• Study First Posted: 2013-01-30
• Primary Completion: 2018-01-06
• Study Completion: 2018-01-06
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-01
• Last Update Posted: 2018-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BU-CY	Busulfan-Cyclophosphamide as Conditioning Regimen before Allogeneic Hematopoietic Stem Cell Transplantation	Group A (standard group): conditioning regimen with Busulfan (BU) followed by Cyclophosphamide (CY)
CY-BU	Cyclophosphamide-Busulfan as Conditioning Regimen before Allogeneic Hematopoietic Stem Cell Transplantation	Group B (experimental group): conditioning regimen with Cyclophosphamide (CY) followed by Busulfan (BU)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
VOD	Day 30	Incidence and severity of "veno occlusive disease (VOD)" at day 30
Acute graft-versus-host disease (GvHD)	Day 30 and Day 100	Incidence and severity of acute GVHD, by organ (skin, liver, gut) at day 30 and day 100
Efficacy	Day 30 and Day 100	Survival, relapse and non-relapse mortality at day 30 and day 100
Toxicity	Day 30 and Day 100	Organ toxicity at day 30 and day 100
Maximum liver values	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
Cumulative liver values	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

Trial Locations

Locations (3)

University Hospital, Basel; 🇨🇭 Basel, Switzerland

University Hospital Geneva; 🇨🇭 Geneva, Switzerland

University Hospital Zurich; 🇨🇭 Zurich, Switzerland