NCT01119066

HLA-Compatible Related or Unrelated Donors With CD34+ Enriched, T-cell Depleted Peripheral Blood Stem Cells Isolated by the CliniMACS System in the Treatment of Patients With Hematologic Malignancies

A Phase II Trial of Transplants From HLA-Compatible Related or Unrelated Donors With CD34+ Enriched, T-cell Depleted Peripheral Blood Stem Cells Isolated by the CliniMACS System in the Treatment of Patients With Hematologic Malignancies and Other Lethal Hematologic Disorders

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 422 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 69 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out the effects of using a system called CliniMACS to remove Tcells from blood stem cells. Removing T-cells may help stop a side effect called Graft-Versus-Host Disease (GVHD). Some studies have been done with CliniMACS, but the Food and Drug Administration (FDA) has not yet approved it.

Conditions

• Acute Lymphoblastic Leukemia
• Acute Myelogenous Leukemia
• Myelodysplastic Syndrome
• Multiple Myeloma

Interventions

Type	Name	Description
RADIATION	total body irradiation	dose of 1375-1500 cGy
DRUG	Thiotepa	5 mg/kg/day x 2 or 10 mg/kg/day x 1
DRUG	Cyclophosphamide	60 mg/ kg/day x 2 (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated).
DRUG	Busulfan	0.8 mg/kg every 6 hours x 10 or 12 doses (depending on disease) with dose modified according to pharmacokinetics
DRUG	Melphalan	70mg/m2/day x 2
DRUG	Fludarabine	25mg/m2/ day x 5
DRUG	Clofarabine	20mg/m2/ day x 5 (or, for children \<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval)
PROCEDURE	(CliniMACS) T-cell depleted PBSC Transplant

Timeline

• Start date: 2010-05-03
• Primary completion: 2021-03-30
• Completion: 2021-03-30
• First posted: 2010-05-07
• Last updated: 2022-08-05
• Results posted: 2022-08-05

Locations

1 site across 1 country: United States