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Stem Cell Transplant

Bone Marrow Transplant for Blood Diseases (2019-KOE-001 Trial)

Phase 2
Waitlist Available
Led By Guenther Koehne, MD
Research Sponsored by Baptist Health South Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months, 1 year, 2 years
Awards & highlights

2019-KOE-001 Trial Summary

This trial is testing two different conditioning regimens to see which is more effective in reducing the risk of disease relapse after a stem cell transplant. The CliniMACS system is used to positively select CD34+ progenitor cells from the peripheral blood stem cells. This is done by immunoadsorption of cells binding to an anti-CD34 monoclonal antibody to paramagnetic beads. The beads are then passed through a magnetized column and released by agitation.

Eligible Conditions
  • Blood Diseases
  • Blood Cancers
  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • Leukemia
  • Chronic Lymphocytic Leukemia

2019-KOE-001 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months, 1 year, 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months, 1 year, 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assess the change of incidence and severity of acute GvHD
Assess the change of incidence and severity of chronic GvHD
Assess the change of incidence of non-relapse mortality
+1 more
Secondary outcome measures
Correlate doses of CD34+ progenitors and CD3+ T cells with engraftment
Determine the proportion of patients receiving optimal CD34+; CD3+

2019-KOE-001 Trial Design

2Treatment groups
Experimental Treatment
Group I: Regimen BExperimental Treatment5 Interventions
Regimen B: Busulfan/Melphalan/Fludarabine: Busulfan 0.8mg/kg/dose every six hours x 10-12 doses (depending on disease), Melphalan 70mg/m2/day x 2 and Fludarabine 25mg/m2/day x 5.
Group II: Regimen AExperimental Treatment5 Interventions
Regimen A: Hyperfractionated Total Body Irradiation/Thiotepa/Cyclophosphamide: Hyperfractionated total body irradiation to dose of 1375cGy fractions at 4-6 hour intervals three times a day for a total of 11 or 12 doses depending on age and disease risk, followed by Thiotepa 5mg/kg/day x 2 (or 10mg/kg/day x 1) and cyclophosphamide 60mg/kg/day x 2 (or Fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CliniMACS
2005
Completed Phase 3
~770
Bone Marrow Transplant
2015
Completed Phase 2
~60
Thiotepa
2008
Completed Phase 3
~2150
Cyclophosphamide
1995
Completed Phase 3
~3770
Busulfan
2008
Completed Phase 3
~1120
Melphalan
2008
Completed Phase 3
~1500
Fludarabine
2012
Completed Phase 3
~1100

Find a Location

Who is running the clinical trial?

Baptist Health South FloridaLead Sponsor
48 Previous Clinical Trials
7,831 Total Patients Enrolled
Guenther Koehne, MDPrincipal InvestigatorMiami Cancer Institute (MCI) at Baptist Health, Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
CD34+ Enriched Transplants From HLA-Compatible Patients With Hematologic Malignancies
2022. "CD34+ Enriched Transplants From HLA-Compatible Patients With Hematologic Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04282174.
~0 spots leftby Mar 2030
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