Myeloid MalignanciesPhase 3FLUBUTBINCT01366612

Fludarabine and Busulfan vs. Fludarabine, Busulfan and Total Body Irradiation

A Phase 3 study testing Fludarabine and Busulfan plus/minus Total Body Irradiation (low dose) and Fludarabine and Busulfan + Low Dose Total Body Irradiation (LD TBI) in people with Myeloid Malignancies and Acute Myelogenous Leukemia, run by Hackensack Meridian Health at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Myeloid Malignancies, Acute Myelogenous Leukemia, Chronic Myelogenous Leukemia
What is being tested?: Fludarabine and Busulfan plus/minus Total Body Irradiation (low dose) and Fludarabine and Busulfan + Low Dose Total Body Irradiation (LD TBI)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 53 participants
Where: 1 siteUnited States
Study dates: 16 Jun 2010to 18 Aug 2020
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of acute myelogenous leukemia, chronic myelogenous leukemia, other myeloproliferative disorder, or myelodysplastic syndrome
Any stage of disease will be considered for transplantation
Have a suitable related or unrelated donor (Section 3.3)
Age ≥18 but <70 yrs
KPS of ≥70%
Recovery from all hematologic and non-hematology toxicities from previous therapies.

Who cannot join

Diagnosis other than acute myelogenous leukemia, myeloproliferative disorder, or myelodysplastic syndrome
Chemotherapy or radiotherapy within 14 days of initiating treatment in this study with the exception of lenalidomide, decitabine, azacitidine, imatinib mesylate, dasatinib, nilotinib hydrochloride and hydroxyurea
Prior dose-intense therapy requiring HSC support within 56 days of initiating treatment in this study
Uncontrolled bacterial, viral, fungal or parasitic infections
Uncontrolled CNS metastases
Known amyloid deposition in heart

Show all 24Show fewer

Organ dysfunction
LVEF <40% or cardiac failure not responsive to therapy
FVC, FEV1, or DLCO <50% of predicted and/or receiving supplementary continuous oxygen
Evidence of hepatic synthetic dysfunction, or total bilirubin >2x or AST >3x ULN
Measured creatinine clearance <20 ml/min
Karnofsky score <70%
Life expectancy limited by another co-morbid illness
Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy
Female subject is pregnant or breast-feeding (women) or unwilling to use acceptable birth control methods (men or women) for twelve months after treatment. Confirmation that the subject is not pregnant must be established by a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
Documented hypersensitivity to fludarabine or melphalan or to bortezomib, boron or mannitol or any components of the formulation
Patients unable or unwilling to provide consent
Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see section 8.4), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening has to be documented by the investigator as not medically relevant
Patient has received other investigational drugs with 14 days before enrollment
Serious medical or psychiatric illness likely to interfere with participation in this clinical study
Donor Inclusion and Exclusion Criteria
Donor Inclusion Criteria:
HLA 6/6 (HLA-A, B, DrB1) related donor or 7/8 (HLA-A, B, C, DrB1) unrelated donor Related donors will be evaluated in accordance with HUMC standard practice guidelines for the evaluation and management of allogeneic donors Unrelated donors will be identified, evaluated, and managed in accordance with National Marrow Donor Program standards Age ≥18 and <70 yrs KPS of ≥70% Willing to donate bone marrow using standard techniques or peripheral blood HSC by leukapheresis Have adequate veins for apheresis or agree to placement of a central venous catheter (femoral, subclavian) if donating peripheral blood HSC
Donor Exclusion Criteria Identical twin Female donors who are pregnant or breastfeeding Infection with HIV or viral hepatitis (B or C) Known allergy to filgrastim Current serious systemic illness Uncontrolled bacterial, viral, or fungal infection Receiving experimental therapy or investigational agents History of cancer other than treated basal cell cancer of the skin or carcinoma in situ of the cervix. Cancer treated with curative intent >5 yrs before donation will be reviewed on a case-by-case basis by the principal investigator

Trial locations and contacts

1 site in 1 country.

United States1 site

John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601

Other trials in United States

About this study

Official title: PRO#1278: A Phase III Study of Fludarabine and Busulfan Versus Fludarabine, Busulfan and Low Dose Total Body Irradiation in Patients Receiving an Allogeneic Hematopoietic Stem Cell Transplant

This is a single institution study of fludarabine and busulfan versus fludarabine, busulfan and low dose total body irradiation in patients undergoing allogeneic stem cell transplantation. A study population of 80 subjects will be enrolled from The John Theurer Cancer Center at Hackensack University Medical Center. Subjects who are eligible to receive allogeneic hematopoietic stem cell transplantation according to the eligibility criteria will be consented and enrolled. Subjects will be randomly assigned to receive one of 2 conditioning regimen: fludarabine and busulfan, or fludarabine busulfan and low dose total body irradiation (TBI). Subjects will be followed until 1 year post transplantation to assess the relapse rate in each arm and transplant-related toxicity.

The combination of fludarabine and busulfan is the current standard of care for patients with myeloid malignancies (AML, CML and other myeloproliferative disorders, or MDS) undergoing allogeneic transplantation at HUMC. In this study we will be comparing in a randomized fashion the standard regimen to a regimen of fludarabine, busulfan and TBI.

Read the detailed description

The combination of fludarabine and busulfan is the current standard of care for patients with myeloid malignancies (myelogenous leukemia, chronic myelogenous leukemia, other myeloproliferative disorder, or myelodysplastic syndrome) undergoing allogeneic transplantation at HUMC. In this study we will be comparing in a randomized fashion the standard regimen to a regimen of fludarabine, busulfan and TBI.

Primary Objective The primary objective is to compare the relapse rate at 1 year of patients with myeloid malignancies receiving each regimen.

Secondary Objectives The secondary objective is to compare the toxicity of each regimen

Conditions: Myeloid Malignancies, Acute Myelogenous Leukemia, Chronic Myelogenous Leukemia, Myeloproliferative Disorders, Myelodysplastic Syndrome
Being tested: Fludarabine and Busulfan plus/minus Total Body Irradiation (low dose), Fludarabine and Busulfan + Low Dose Total Body Irradiation (LD TBI)
Keywords: Allogeneic Stem Cell Transplant, AML, CML, MDS
Medical subject headings: Leukemia, Myeloid, Acute, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Myeloproliferative Disorders, Myelodysplastic Syndromes

What participants receive

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

Fludarabine and Busulfan plus/minus Total Body Irradiation (low dose)Drug
Also called Fludara, Busulfex
Fludarabine 40mg/m2 and Busulfan 130mg/m2 on days -6, -5, -4 and -3 of transplant.
rATG on days -3, -2 and -1
Fludarabine and Busulfan + Low Dose Total Body Irradiation (LD TBI)Drug
Also called Fludara, Busulfex
Fludarabine 40mg/m2 and Busulfan 130mg/m2 on days -6, -5, -4 and -3 of transplant.
rATG on days -3, -2 and -1 TBI 200cGY (as randomized) on day -1

Study groups in NCT01366612
Study group	Role	What they receive
Group 1	Active comparator	FLUDARABINE AND BUSULFAN Receives: Drug: Fludarabine and Busulfan plus/minus Total Body Irradiation (low dose)
Group 2	Experimental	FLUDARABINE, BUSULFAN AND LOW DOSE TOTAL BODY IRRADIATION Receives: Drug: Fludarabine and Busulfan + Low Dose Total Body Irradiation (LD TBI)

What is being measured

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

To Compare the Relapse Rate at 1 Year of Patients With Myeloid Malignancies Receiving Each Treatment
Measured: 1 year

Timeline

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

16 Jun 201018 Aug 2020

First posted6 Jun 2011 (estimated)
Study start16 Jun 2010
Primary completion17 Aug 2020
Study completion18 Aug 2020

Why it stopped: Lack of Accrual

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Myeloid MalignanciesStudies of the same condition, open and under way.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01366612
Sponsor's protocol ID: Pro00001278
Other IDs: Flu-Bu-TBI
Acronym: FLUBUTBI
Status last verified: Mar 2026
First submitted: 2 Jun 2011
Last updated: 3 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Muller CI, Ruter B, Koeffler HP, Lubbert M. DNA hypermethylation of myeloid cells, a novel therapeutic target in MDS and AML. Curr Pharm Biotechnol. 2006 Oct;7(5):315-21. doi: 10.2174/138920106778521523.
PubMed 17076647
Martin S, Baldock SC, Ghoneim AT, Child JA. Defective neutrophil function and microbicidal mechanisms in the myelodysplastic disorders. J Clin Pathol. 1983 Oct;36(10):1120-8. doi: 10.1136/jcp.36.10.1120.
PubMed 6311878
Martino R, Iacobelli S, Brand R, Jansen T, van Biezen A, Finke J, Bacigalupo A, Beelen D, Reiffers J, Devergie A, Alessandrino E, Mufti GJ, Barge R, Sierra J, Ruutu T, Boogaerts M, Falda M, Jouet JP, Niederwieser D, de Witte T; Myelodysplastic Syndrome subcommittee of the Chronic Leukemia Working Party of the European Blood and Marrow Transplantation Group. Retrospective comparison of reduced-intensity conditioning and conventional high-dose conditioning for allogeneic hematopoietic stem cell transplantation using HLA-identical sibling donors in myelodysplastic syndromes. Blood. 2006 Aug 1;108(3):836-46. doi: 10.1182/blood-2005-11-4503. Epub 2006 Apr 4.
PubMed 16597592
Fukuda T, Hackman RC, Guthrie KA, Sandmaier BM, Boeckh M, Maris MB, Maloney DG, Deeg HJ, Martin PJ, Storb RF, Madtes DK. Risks and outcomes of idiopathic pneumonia syndrome after nonmyeloablative and conventional conditioning regimens for allogeneic hematopoietic stem cell transplantation. Blood. 2003 Oct 15;102(8):2777-85. doi: 10.1182/blood-2003-05-1597. Epub 2003 Jul 10.
PubMed 12855568
Diaconescu R, Flowers CR, Storer B, Sorror ML, Maris MB, Maloney DG, Sandmaier BM, Storb R. Morbidity and mortality with nonmyeloablative compared with myeloablative conditioning before hematopoietic cell transplantation from HLA-matched related donors. Blood. 2004 Sep 1;104(5):1550-8. doi: 10.1182/blood-2004-03-0804. Epub 2004 May 18.
PubMed 15150081
de Lima M, Anagnostopoulos A, Munsell M, Shahjahan M, Ueno N, Ippoliti C, Andersson BS, Gajewski J, Couriel D, Cortes J, Donato M, Neumann J, Champlin R, Giralt S. Nonablative versus reduced-intensity conditioning regimens in the treatment of acute myeloid leukemia and high-risk myelodysplastic syndrome: dose is relevant for long-term disease control after allogeneic hematopoietic stem cell transplantation. Blood. 2004 Aug 1;104(3):865-72. doi: 10.1182/blood-2003-11-3750. Epub 2004 Apr 15.
PubMed 15090449
Andersson BS, de Lima M, Thall PF, Wang X, Couriel D, Korbling M, Roberson S, Giralt S, Pierre B, Russell JA, Shpall EJ, Jones RB, Champlin RE. Once daily i.v. busulfan and fludarabine (i.v. Bu-Flu) compares favorably with i.v. busulfan and cyclophosphamide (i.v. BuCy2) as pretransplant conditioning therapy in AML/MDS. Biol Blood Marrow Transplant. 2008 Jun;14(6):672-84. doi: 10.1016/j.bbmt.2008.03.009.
PubMed 18489993
Bredeson CN, Zhang MJ, Agovi MA, Bacigalupo A, Bahlis NJ, Ballen K, Brown C, Chaudhry MA, Horowitz MM, Kurian S, Quinlan D, Muehlenbien CE, Russell JA, Savoie L, Rizzo JD, Stewart DA. Outcomes following HSCT using fludarabine, busulfan, and thymoglobulin: a matched comparison to allogeneic transplants conditioned with busulfan and cyclophosphamide. Biol Blood Marrow Transplant. 2008 Sep;14(9):993-1003. doi: 10.1016/j.bbmt.2008.06.009.
PubMed 18721762
Russell JA, Savoie ML, Balogh A, Turner AR, Larratt L, Chaudhry MA, Storek J, Bahlis NJ, Brown CB, Quinlan D, Geddes M, Stewart DA. Allogeneic transplantation for adult acute leukemia in first and second remission with a novel regimen incorporating daily intravenous busulfan, fludarabine, 400 CGY total-body irradiation, and thymoglobulin. Biol Blood Marrow Transplant. 2007 Jul;13(7):814-21. doi: 10.1016/j.bbmt.2007.03.003. Epub 2007 Apr 23.
PubMed 17580259
Cox, DR. Regression models and life tables (with discussion). J R Stat Soc B.1972; 34:187-220.
Cleveland, WS. Robust locally-weighted regression and smoothing scatterplots. J. Am Stat Assoc. 1979; 74: 829-836.
Suh HC, Rowley SD, Kaur S, Lukasik B, McKiernan P, Boonstra M, Baker M, DiLorenzo M, Skarbnik A, Voss J, Hampson A, DeAgresta B, Boylan B, Nyirenda T, Vesole DH, Donato ML. Prospective, Randomized, Comparative Study of Myeloablative Fludarabine/Busulfan and Fludarabine/Busulfan/Total Body Irradiation Conditioning in Myeloid Diseases. Cancers (Basel). 2025 Mar 28;17(7):1140. doi: 10.3390/cancers17071140.
PubMed 40227676

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

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All Myeloid Malignancies trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PRO#1278: A Phase III Study of Fludarabine and Busulfan Versus Fludarabine, Busulfan and Low Dose Total Body Irradiation in Patients Receiving an Allogeneic Hematopoietic Stem Cell Transplant
ClinicalTrials.gov ID: NCT01366612
Acronym / sponsor ID: FLUBUTBI / Pro00001278
Conditions: Myeloid Malignancies, Acute Myelogenous Leukemia, Chronic Myelogenous Leukemia, Myeloproliferative Disorders, Myelodysplastic Syndrome
Keywords: Allogeneic Stem Cell Transplant, AML, CML, MDS
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Lack of Accrual
Enrolment: 53 participants (actual)
Lead sponsor: Hackensack Meridian HealthUniversity, hospital or other
Study start: 16 Jun 2010 (actual)
Primary completion: 17 Aug 2020 (actual)
Study completion: 18 Aug 2020 (actual)
First posted: 6 Jun 2011 (estimated)
Results: Posted 16 Dec 2022

Clinical summary

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

Detailed description

Primary Objective The primary objective is to compare the relapse rate at 1 year of patients with myeloid malignancies receiving each regimen.

Secondary Objectives The secondary objective is to compare the toxicity of each regimen

Study design

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

Arm	Type	Receives
Group 1	Active comparator	Drug: Fludarabine and Busulfan plus/minus Total Body Irradiation (low dose)FLUDARABINE AND BUSULFAN
Group 2	Experimental	Drug: Fludarabine and Busulfan + Low Dose Total Body Irradiation (LD TBI)FLUDARABINE, BUSULFAN AND LOW DOSE TOTAL BODY IRRADIATION

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Diagnosis of acute myelogenous leukemia, chronic myelogenous leukemia, other myeloproliferative disorder, or myelodysplastic syndrome
Any stage of disease will be considered for transplantation
Have a suitable related or unrelated donor (Section 3.3)
Age ≥18 but <70 yrs
KPS of ≥70%

Key exclusion criteria (24 listed)

Diagnosis other than acute myelogenous leukemia, myeloproliferative disorder, or myelodysplastic syndrome
Chemotherapy or radiotherapy within 14 days of initiating treatment in this study with the exception of lenalidomide, decitabine, azacitidine, imatinib mesylate, dasatinib, nilotinib hydrochloride and hydroxyurea
Prior dose-intense therapy requiring HSC support within 56 days of initiating treatment in this study
Uncontrolled bacterial, viral, fungal or parasitic infections
Uncontrolled CNS metastases

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
Fludarabine and Busulfan plus/minus Total Body Irradiation (low dose)Also: Fludara, BusulfexFludarabine 40mg/m2 and Busulfan 130mg/m2 on days -6, -5, -4 and -3 of transplant. rATG on days -3, -2 and -1	Drug	Group 1
Fludarabine and Busulfan + Low Dose Total Body Irradiation (LD TBI)Also: Fludara, BusulfexFludarabine 40mg/m2 and Busulfan 130mg/m2 on days -6, -5, -4 and -3 of transplant. rATG on days -3, -2 and -1 TBI 200cGY (as randomized) on day -1	Drug	Group 2

Primary outcome

To Compare the Relapse Rate at 1 Year of Patients With Myeloid Malignancies Receiving Each Treatment
Time frame: 1 year

Results and safety

Results posted to the registry on 16 Dec 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1	25	25
Group 2	22	22

Primary outcome: To Compare the Relapse Rate at 1 Year of Patients With Myeloid Malignancies Receiving Each Treatment

Time frame: 1 year. Number. Unit: Percent

Measure	Group 1 n = 18	Group 2 n = 16
Value	38.9	18.8

Population analysed: Relapse Rate was analyzed in 34 patients with AML

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1	18 of 25 (72%)	0 of 25 (0%)	6 of 25
Group 2	16 of 22 (72.7%)	0 of 22 (0%)	8 of 22

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17076647Muller CI, Ruter B, Koeffler HP, Lubbert M. DNA hypermethylation of myeloid cells, a novel therapeutic target in MDS and AML. Curr Pharm Biotechnol. 2006 Oct;7(5):315-21. doi: 10.2174/138920106778521523.
Background: PubMed 6311878Martin S, Baldock SC, Ghoneim AT, Child JA. Defective neutrophil function and microbicidal mechanisms in the myelodysplastic disorders. J Clin Pathol. 1983 Oct;36(10):1120-8. doi: 10.1136/jcp.36.10.1120.
Background: PubMed 16597592Martino R, Iacobelli S, Brand R, Jansen T, van Biezen A, Finke J, Bacigalupo A, Beelen D, Reiffers J, Devergie A, Alessandrino E, Mufti GJ, Barge R, Sierra J, Ruutu T, Boogaerts M, Falda M, Jouet JP, Niederwieser D, de Witte T; Myelodysplastic Syndrome subcommittee of the Chronic Leukemia Working Party of the European Blood and Marrow Transplantation Group. Retrospective comparison of reduced-intensity conditioning and conventional high-dose conditioning for allogeneic hematopoietic stem cell transplantation using HLA-identical sibling donors in myelodysplastic syndromes. Blood. 2006 Aug 1;108(3):836-46. doi: 10.1182/blood-2005-11-4503. Epub 2006 Apr 4.
Background: PubMed 12855568Fukuda T, Hackman RC, Guthrie KA, Sandmaier BM, Boeckh M, Maris MB, Maloney DG, Deeg HJ, Martin PJ, Storb RF, Madtes DK. Risks and outcomes of idiopathic pneumonia syndrome after nonmyeloablative and conventional conditioning regimens for allogeneic hematopoietic stem cell transplantation. Blood. 2003 Oct 15;102(8):2777-85. doi: 10.1182/blood-2003-05-1597. Epub 2003 Jul 10.
Background: PubMed 15150081Diaconescu R, Flowers CR, Storer B, Sorror ML, Maris MB, Maloney DG, Sandmaier BM, Storb R. Morbidity and mortality with nonmyeloablative compared with myeloablative conditioning before hematopoietic cell transplantation from HLA-matched related donors. Blood. 2004 Sep 1;104(5):1550-8. doi: 10.1182/blood-2004-03-0804. Epub 2004 May 18.
Background: PubMed 15090449de Lima M, Anagnostopoulos A, Munsell M, Shahjahan M, Ueno N, Ippoliti C, Andersson BS, Gajewski J, Couriel D, Cortes J, Donato M, Neumann J, Champlin R, Giralt S. Nonablative versus reduced-intensity conditioning regimens in the treatment of acute myeloid leukemia and high-risk myelodysplastic syndrome: dose is relevant for long-term disease control after allogeneic hematopoietic stem cell transplantation. Blood. 2004 Aug 1;104(3):865-72. doi: 10.1182/blood-2003-11-3750. Epub 2004 Apr 15.
Background: PubMed 18489993Andersson BS, de Lima M, Thall PF, Wang X, Couriel D, Korbling M, Roberson S, Giralt S, Pierre B, Russell JA, Shpall EJ, Jones RB, Champlin RE. Once daily i.v. busulfan and fludarabine (i.v. Bu-Flu) compares favorably with i.v. busulfan and cyclophosphamide (i.v. BuCy2) as pretransplant conditioning therapy in AML/MDS. Biol Blood Marrow Transplant. 2008 Jun;14(6):672-84. doi: 10.1016/j.bbmt.2008.03.009.
Background: PubMed 18721762Bredeson CN, Zhang MJ, Agovi MA, Bacigalupo A, Bahlis NJ, Ballen K, Brown C, Chaudhry MA, Horowitz MM, Kurian S, Quinlan D, Muehlenbien CE, Russell JA, Savoie L, Rizzo JD, Stewart DA. Outcomes following HSCT using fludarabine, busulfan, and thymoglobulin: a matched comparison to allogeneic transplants conditioned with busulfan and cyclophosphamide. Biol Blood Marrow Transplant. 2008 Sep;14(9):993-1003. doi: 10.1016/j.bbmt.2008.06.009.
Background: PubMed 17580259Russell JA, Savoie ML, Balogh A, Turner AR, Larratt L, Chaudhry MA, Storek J, Bahlis NJ, Brown CB, Quinlan D, Geddes M, Stewart DA. Allogeneic transplantation for adult acute leukemia in first and second remission with a novel regimen incorporating daily intravenous busulfan, fludarabine, 400 CGY total-body irradiation, and thymoglobulin. Biol Blood Marrow Transplant. 2007 Jul;13(7):814-21. doi: 10.1016/j.bbmt.2007.03.003. Epub 2007 Apr 23.
BackgroundCox, DR. Regression models and life tables (with discussion). J R Stat Soc B.1972; 34:187-220.
BackgroundCleveland, WS. Robust locally-weighted regression and smoothing scatterplots. J. Am Stat Assoc. 1979; 74: 829-836.
Derived from this study: PubMed 40227676Suh HC, Rowley SD, Kaur S, Lukasik B, McKiernan P, Boonstra M, Baker M, DiLorenzo M, Skarbnik A, Voss J, Hampson A, DeAgresta B, Boylan B, Nyirenda T, Vesole DH, Donato ML. Prospective, Randomized, Comparative Study of Myeloablative Fludarabine/Busulfan and Fludarabine/Busulfan/Total Body Irradiation Conditioning in Myeloid Diseases. Cancers (Basel). 2025 Mar 28;17(7):1140. doi: 10.3390/cancers17071140.

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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.

Michele Donato, MD principal investigator

Hackensack Meridian Health

1 site 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 24 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: stopped early, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

To Compare the Relapse Rate at 1 Year of Patients With Myeloid Malignancies Receiving Each Treatment (time frame: 1 year). 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 NCT01366612, which also lists 12 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 3 Apr 2026.