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CD34+ Peripheral Blood Progenitor Cell (PBSC) Transplant with Busulfan/Melphalan/Fludarabine Regimen for Myelodysplastic Syndrome

Phase 2

Waitlist Available

Led By Guenther Koehne, M.D.

Research Sponsored by Guenther Koehne

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 weekly until 3 months, monthly until 6 months, 12 months, 24 months

Awards & highlights

Study Summary

This trial will evaluate if the CliniMACS system reduces the risk of complications for those getting a stem cell transplant to treat blood cancer or disorders.

Eligible Conditions

Myelodysplastic Syndrome
Graft-versus-Host Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weekly until 3 months, monthly until 6 months, 12 months, 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weekly until 3 months, monthly until 6 months, 12 months, 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and weekly until 3 months, monthly until 6 months, 12 months, 24 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Disease

Bone Transplantation

Change in incidence of relapse-free mortality (transplant-related mortality)

+3 more

Secondary outcome measures

Proportion of patients receiving optimal vs. suboptimal CD34+/CD3+ PBSC doses

Trial Design

1Treatment groups

Experimental Treatment

Group I: CD34+ Peripheral Blood Progenitor Cell (PBSC) Transplant with Busulfan/Melphalan/Fludarabine RegimenExperimental Treatment4 Interventions

Cytoreduction therapy: 0.8 mg/kg q6h x 12 doses busulfan via IV injection 70 mg/m^2/day x 2 days melphalan via IV infusion over 30 minutes 25 mg/m^2/day x 5 days fludarabine vis IV infusion over 30 minutes CD34+ selected, T-cell depleted, allogeneic PBSC transplant using CliniMACS system to select CD34+ cells

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Busulfan

2008

Completed Phase 3

~1120

Melphalan

2008

Completed Phase 3

~1500

Fludarabine

2012

Completed Phase 3

~1100

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Guenther KoehneLead Sponsor

2 Previous Clinical Trials

120 Total Patients Enrolled

Baptist Health South FloridaLead Sponsor

48 Previous Clinical Trials

7,781 Total Patients Enrolled

Guenther Koehne, M.D.Principal InvestigatorMiami Cancer Institute/Baptist Health South Florida

Media Library

CliniMACS CD34+ enriched, T-cell depleted peripheral blood stem cell (PBSC) (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05617625 — Phase 2

Myelodysplastic Syndrome Research Study Groups: CD34+ Peripheral Blood Progenitor Cell (PBSC) Transplant with Busulfan/Melphalan/Fludarabine Regimen

Myelodysplastic Syndrome Clinical Trial 2023: CliniMACS CD34+ enriched, T-cell depleted peripheral blood stem cell (PBSC) Highlights & Side Effects. Trial Name: NCT05617625 — Phase 2

CliniMACS CD34+ enriched, T-cell depleted peripheral blood stem cell (PBSC) (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05617625 — Phase 2

Frequently Asked Questions

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

Does this clinical trial accept participants aged 50 or above?

"Applicants must be between the ages of 18 and 75 to qualify for this trial. However, there are 475 trials specifically designed for people younger than 18, and 1298 clinical trials that target individuals over 65 years old."

Answered by AI

To what extent is CD34+ Peripheral Blood Progenitor Cell (PBSC) Transplant with Busulfan/Melphalan/Fludarabine Regimen a secure option for individuals?

"Although there is some data confirming the safety of CD34+ Peripheral Blood Progenitor Cell (PBSC) Transplant with Busulfan/Melphalan/Fludarabine Regimen, it has a score of 2 as no efficacy studies have yet been conducted."

Answered by AI

Are there any openings to join this research endeavor?

"According to the information published on clinicaltrials.gov, this particular trial is no longer actively recruiting participants. Initially posted on December 1st 2022 and last modified November 15th 2022, it does not appear that any more candidates are required at present; however, 1747 other studies still require enrolment from volunteers."

Answered by AI

To whom is this clinical investigation open?

"This research initiative is recruiting 50 people with the illness between 18 and 75 years of age. To be eligible, individuals must have Myelodysplastic syndrome (MDS): Refractory Anemia/Refractory Anemia with Ring Sideroblasts/Refractory Cytopenia with Multilineage Anemia (RA/RARS/RCMA) including high-risk cytogenetic features or transfusion dependence; Refractory Anemia with Excess Blasts Type 1 and 2 (RAEB-1 and RAEB-2), a Karnofsky Performance Status of at least 70%, an"

Answered by AI

Recent research and studies

BloodJournal

Risk Factors for Acute Graft-versus-host Disease in Patients Undergoing Transplantation with CD34+ Selected Blood Cells from Hla-identical Siblings

Urbano-Ispizua, Alvaro, Ciril Rozman, Pedro Pimentel, Carlos Solano, Javier de la Rubia, Salut Brunet, Jaime Pérez-Oteyza, et al.. 2002. “Risk Factors for Acute Graft-versus-host Disease in Patients Undergoing Transplantation with CD34+ Selected Blood Cells from Hla-identical Siblings”. Blood. American Society of Hematology. doi:10.1182/blood-2001-11-0057.

Bone Marrow TransplantationJournal

Megadose Transplantation of Purified Peripheral Blood Cd34+progenitor Cells from Hla-mismatched Parental Donors in Children

Handgretinger, R, T Klingebiel, P Lang, M Schumm, S Neu, A Geiselhart, P Bader, et al.. 2001. “Megadose Transplantation of Purified Peripheral Blood Cd34+progenitor Cells from Hla-mismatched Parental Donors in Children”. Bone Marrow Transplantation. Springer Science and Business Media LLC. doi:10.1038/sj.bmt.1702996.

clinicaltrials.govStudy

CD34+ Enriched Transplants to Treat Myelodysplastic Syndrome

Guenther Koehne 2024. "CD34+ Enriched Transplants to Treat Myelodysplastic Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05617625.