Trials / Suspended
SuspendedNCT05617625
CD34+ Enriched Transplants to Treat Myelodysplastic Syndrome
A Phase II Trial of CD34+ Enriched Transplants From HLA-Compatible Related or Unrelated Donors for Treatment of Patients With Myelodysplastic Syndrome
- Status
- Suspended
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Guenther Koehne · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2026-06-01
- Primary completion
- 2033-06-01
- Completion
- 2033-06-01
- First posted
- 2022-11-15
- Last updated
- 2026-03-03
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05617625. Inclusion in this directory is not an endorsement.