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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 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
~1080

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
50 Previous Clinical Trials
7,819 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
~33 spots leftby Jun 2031
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