NCT05565105

CD34+ Transplants for Leukemia and Lymphoma

A Phase II Trial of CD34+ Enriched Transplants From HLA-Compatible Related or Unrelated Donors for Treatment of Patients With Leukemia or Lymphoma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Guenther Koehne · Academic / Other
• Sex: All
• Age: 18 Years – 74 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 less complications for patients undergoing transplant for treatment of a blood malignancy (cancer) or blood disorder.

Conditions

• Leukemia, Myeloid, Acute
• Leukemia, Lymphocytic, Acute

Interventions

Type	Name	Description
RADIATION	Total Body Irradiation (TBI)	Hyper-fractioned TBI is administered by a linear accelerator at a dose rate of \< 15 cGy/minute.
DRUG	Thiotepa	Thiotepa: 5 mg/kg/day IV over approximately 4 hours daily x 2 (Day -5 and Day -4).
DRUG	Cyclophosphamide	Cyclophosphamide: 60 mg/kg/day x 2 or Fludarabine 25 mg/m\^2 x 5 if cyclophosphamide is contraindicated
DRUG	Busulfan	Busulfan: 0.8 mg/kg every 6 hours x 10 or 12 doses (depending on disease) with dose modified according to pharmacokinetics
DRUG	Melphalan	Melphalan: 70 mg/m\^2/day x 2
DRUG	Fludarabine	Fludarabine: 25 mg/m\^2/day x 5

Timeline

• Start date: 2026-06-01
• Primary completion: 2033-06-01
• Completion: 2033-06-01
• First posted: 2022-10-04
• Last updated: 2026-03-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study