Myeloid LeukemiaNCT01779882

Cyclophosphamide and Busulfan as Conditioning Regimen Before Allogeneic HSCT

A study testing Busulfan-Cyclophosphamide as Conditioning Regimen before Allogeneic Hematopoietic Stem Cell Transplantation and Cyclophosphamide-Busulfan as Conditioning Regimen before Allogeneic Hematopoietic Stem Cell Transplantation in people with Myeloid Leukemia and Precursor Myeloid Neoplasms, run by University Hospital, Basel, Switzerland at 3 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Myeloid Leukemia, Precursor Myeloid Neoplasms, Lymphoid Neoplasms
What is being tested?: Busulfan-Cyclophosphamide as Conditioning Regimen before Allogeneic Hematopoietic Stem Cell Transplantation and Cyclophosphamide-Busulfan as Conditioning Regimen before Allogeneic Hematopoietic Stem Cell Transplantation
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 3 sitesSwitzerland
Study dates: Jan 2013to 6 Jan 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

Switzerland3 sites

University Hospital, Basel
Basel, 4031
University Hospital Geneva
Geneva, 1205
University Hospital Zurich
Zurich, 8091

Other trials in Switzerland

About this study

Official 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

Conditions: Myeloid Leukemia, Precursor Myeloid Neoplasms, Lymphoid Neoplasms
Being tested: Busulfan-Cyclophosphamide as Conditioning Regimen before Allogeneic Hematopoietic Stem Cell Transplantation, Cyclophosphamide-Busulfan as Conditioning Regimen before Allogeneic Hematopoietic Stem Cell Transplantation
Medical subject headings: Leukemia, Myeloid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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
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 groups in NCT01779882
Study group	Role	What they receive
BU-CY	Active comparator	Group A (standard group): conditioning regimen with Busulfan (BU) followed by Cyclophosphamide (CY) Receives: Drug: Busulfan-Cyclophosphamide as Conditioning Regimen before Allogeneic Hematopoietic Stem Cell Transplantation
CY-BU	Experimental	Group B (experimental group): conditioning regimen with Cyclophosphamide (CY) followed by Busulfan (BU) Receives: Drug: Cyclophosphamide-Busulfan as Conditioning Regimen before Allogeneic Hematopoietic Stem Cell Transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (6)

VOD
Incidence and severity of "veno occlusive disease (VOD)" at day 30
Measured: 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
Measured: Day 30 and Day 100
Toxicity
Organ toxicity at day 30 and day 100
Measured: Day 30 and Day 100
Efficacy
Survival, relapse and non-relapse mortality at day 30 and day 100
Measured: 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
Measured: 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
Measured: Day 0, 10, 20 and 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 20136 Jan 2018

First posted30 Jan 2013 (estimated)
Study startJan 2013
Primary completion6 Jan 2018
Study completion6 Jan 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Myeloid LeukemiaStudies of the same condition, open and under way.
More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01779882
Sponsor's protocol ID: BuCyBu study
Status last verified: Mar 2018
First submitted: 28 Jan 2013
Last updated: 2 Mar 2018
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 20548339
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.
PubMed 37085674

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
RecruitingPhase 2
Phase II Study of Asciminib for Second-line Treatment of Chronic Phase Chronic Myeloid Leukemia
Malignant Solid Tumors
RecruitingPhase 2
Phase II Study Assessing Efficacy and Safety of Asciminib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase.
Chronic Myeloid Leukemia
Not yet recruitingPhase 1
Universal 4SCAR7U Targeting CD7-positive Malignancies
T-cell Acute Lymphoblastic Leukemia, T-cell Acute Lymphoblastic Lymphoma
Not yet recruitingPhase 1
Phase I Study Of PLM-102 In Patients With Relapsed And Refractory Acute Myeloid Leukemia
Acute Myeloid Leukemia

All Myeloid Leukemia trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT01779882
Acronym / sponsor ID: BuCyBu study
Conditions: Myeloid Leukemia, Precursor Myeloid Neoplasms, Lymphoid Neoplasms
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: University Hospital, Basel, SwitzerlandUniversity, hospital or other
Collaborators: University Hospital, Zürich, University Hospital, Geneva
Study start: Jan 2013
Primary completion: 6 Jan 2018 (actual)
Study completion: 6 Jan 2018 (actual)
First posted: 30 Jan 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
BU-CY	Active comparator	Drug: Busulfan-Cyclophosphamide as Conditioning Regimen before Allogeneic Hematopoietic Stem Cell TransplantationGroup A (standard group): conditioning regimen with Busulfan (BU) followed by Cyclophosphamide (CY)
CY-BU	Experimental	Drug: Cyclophosphamide-Busulfan as Conditioning Regimen before Allogeneic Hematopoietic Stem Cell TransplantationGroup B (experimental group): conditioning regimen with Cyclophosphamide (CY) followed by Busulfan (BU)

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Busulfan-Cyclophosphamide as Conditioning Regimen before Allogeneic Hematopoietic Stem Cell TransplantationTest 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.	Drug	BU-CY
Cyclophosphamide-Busulfan as Conditioning Regimen before Allogeneic Hematopoietic Stem Cell TransplantationTest 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.	Drug	CY-BU

Primary outcome

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

6 secondary outcomes

VOD
Time frame: Day 30
Acute graft-versus-host disease (GvHD)
Time frame: Day 30 and Day 100
Toxicity
Time frame: Day 30 and Day 100
Efficacy
Time frame: Day 30 and Day 100
Cumulative liver values
Time frame: Day 0, 10, 20 and 30
Maximum liver values
Time frame: Day 0, 10, 20 and 30

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2018.
Background: PubMed 20548339Cantoni 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.
Derived from this study: PubMed 37085674Seydoux 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.

Related trials for Myeloid Leukemia

RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
RecruitingPhase 2
Phase II Study of Asciminib for Second-line Treatment of Chronic Phase Chronic Myeloid Leukemia
Malignant Solid Tumors
RecruitingPhase 2
Phase II Study Assessing Efficacy and Safety of Asciminib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase.
Chronic Myeloid Leukemia
Not yet recruitingPhase 1
Universal 4SCAR7U Targeting CD7-positive Malignancies
T-cell Acute Lymphoblastic Leukemia, T-cell Acute Lymphoblastic Lymphoma
Not yet recruitingPhase 1
Phase I Study Of PLM-102 In Patients With Relapsed And Refractory Acute Myeloid Leukemia
Acute Myeloid Leukemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nathan Cantoni, MD study chair

Kantonsspital Aarau, Switzerland

Sabine Gerull, MD principal investigator

University Hospital, Basel, Switzerland

Gayathri Nair, MD principal investigator

University Hospital, Zürich

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Liver toxicity (time frame: Day 30). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01779882, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2018.