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Alkylating agents

Fludarabine and Busulfan + Low Dose Total Body Irradiation (LD TBI) for Myeloid Leukemia (FLUBUTBI Trial)

Phase 3

Waitlist Available

Led By Michele Donato, MD

Research Sponsored by Hackensack Meridian Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

FLUBUTBI Trial Summary

This trial will compare two ways of preparing patients for stem cell transplants to see which is better at preventing cancer relapse and reducing toxicity. 80 people will be enrolled from The John Theurer Cancer Center and randomly assigned to one of the two ways.

Eligible Conditions

Myeloid Leukemia
Leukemia
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Myeloproliferative Disorder

FLUBUTBI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

FLUBUTBI Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group 2Experimental Treatment1 Intervention

FLUDARABINE, BUSULFAN AND LOW DOSE TOTAL BODY IRRADIATION

Group II: Group 1Active Control1 Intervention

FLUDARABINE AND BUSULFAN

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hackensack Meridian HealthLead Sponsor

131 Previous Clinical Trials

28,191 Total Patients Enrolled

Michele Donato, MDPrincipal InvestigatorHackensack Meridian Health

5 Previous Clinical Trials

267 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To whom is this clinical trial available?

"This study, which will be testing a new medication, is only accepting 47 participants that have myeloproliferative disorders and are between 18-70 years old."

Answered by AI

What are the conditions that are commonly treated with Fludarabine and Busulfan + Low Dose Total Body Irradiation (LD TBI)?

"Fludarabine and Busulfan + Low Dose Total Body Irradiation (LD TBI) is an effective treatment for various cancers including lymphoma, non-hodgkin, leukemia, and allogeneic hematopoietic stem cell transplant, chronic myelogenous leukemia."

Answered by AI

Are there other known cases of using Fludarabine and Busulfan in conjunction with LD TBI?

"At the moment, 423 medical studies are still ongoing that involve Fludarabine and Busulfan + Low Dose Total Body Irradiation (LD TBI). 30 of these trials are currently in Phase 3. Most of the trials for Fludarabine and Busulfan + Low Dose Total Body Irradiation (LD TBI) are based in Philadelphia, Pennsylvania, but there are 4526 locations across the globe where these studies are taking place."

Answered by AI

What are the risks and side-effects associated with Fludarabine and Busulfan + Low Dose Total Body Irradiation (LD TBI)?

"Fludarabine and Busulfan + Low Dose Total Body Irradiation (LD TBI) have gone through multiple rounds of testing, so Power has given it a safety score of 3."

Answered by AI

Does this particular research project allow patients who are over 40 years old to participate?

"The age range for people eligible to participate in this clinical trial is 18-70 years old."

Answered by AI

Can anyone currently enroll in this trial?

"Unfortunately, this particular trial is not recruiting new patients as of February 25th, 2022. According to the same site, the study was first posted on June 16th, 2010. There are, however, over 2000 other trials that are currently enrolling patients."

Answered by AI

Recent research and studies

Current Pharmaceutical BiotechnologyJournal

DNA Hypermethylation of Myeloid Cells, A Novel Therapeutic Target in MDS and AML

Muller, Claudia, Bjorn Ruter, H. Phillip Koeffler, and Michael Lubbert. 2006. “DNA Hypermethylation of Myeloid Cells, A Novel Therapeutic Target in MDS and AML”. Current Pharmaceutical Biotechnology. Bentham Science Publishers Ltd.. doi:10.2174/138920106778521523.

BloodJournal

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

de Lima, Marcos, Athanasios Anagnostopoulos, Mark Munsell, Munir Shahjahan, Naoto Ueno, Cindy Ippoliti, Borje S. Andersson, et al.. 2004. “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. American Society of Hematology. doi:10.1182/blood-2003-11-3750.

Biology of Blood and Marrow TransplantationJournal

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

Andersson, Borje S., Marcos de Lima, Peter F. Thall, Xuemei Wang, Daniel Couriel, Martin Korbling, Soonja Roberson, et al.. 2008. “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”. Biology of Blood and Marrow Transplantation. Elsevier BV. doi:10.1016/j.bbmt.2008.03.009.

BloodJournal