MedTrace Logo

CD34+ Enriched Transplants to Treat Myelodysplastic Syndrome

NCT05617625 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-03-03

No results posted yet for this study

Summary

This study will evaluate whether processing blood stem cell transplants using an investigational device (the CliniMACS system) results in fewer complications for patients who undergo transplant to treat a blood malignancy (cancer) or blood disorder.

The CliniMACS system will be used to remove immune T-cells from the transplant donor's blood. Immune T-cells contribute to graft versus host disease (GVHD) - a serious complication that can happen after transplant. GVHD occurs when a patient's immune system attacks the donor's cells. The study aims to reduce the number of the donor immune T-cells thereby preventing or reducing the severity of GVHD.

Conditions

Interventions

DRUG

Busulfan

0.8 mg/kg q6h x 12 doses via IV injection on Days -9, -8, and -7 prior to transplant

DRUG

Melphalan

70 mg/m\^2/day x 2 days via IV infusion over 30 minutes on Days -6 and -5 prior to transplant

DRUG

Fludarabine

25 mg/m\^2/days x 5 days via IV infusion over 30 minutes on Days -6, -5, -4, -3, and -2 prior to transplant

DEVICE

CliniMACS CD34+ enriched, T-cell depleted peripheral blood stem cell (PBSC)

CliniMACS system will be used to derive CD34+ enriched, T-cell depleted (T-cells limited to 1.0 x 10\^5 CD3+ cells/kg) PBSC for transplant, which will occur on Day 0. PBSC (5 x 10\^6 CD34+ cells/kg) are suspended in a volume of approximately 20-50 mL and delivered via IV infusion over 15 minutes.

Sponsors & Collaborators

  • Guenther Koehne

    lead OTHER

Principal Investigators

  • Guenther Koehne, M.D. · Miami Cancer Institute/Baptist Health South Florida

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2033-06-30
Completion
2033-06-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05617625 on ClinicalTrials.gov