Allo Non-Myeloablative SCT Utilizing Mis-Matched Family Member Stem Cells Purged Using Campath

PHASE2CompletedINTERVENTIONAL
Enrollment

176

Participants

Timeline

Start Date

February 28, 2003

Primary Completion Date

April 30, 2013

Study Completion Date

April 30, 2013

Conditions
LymphomaMyelomaLeukemiaMyelodysplasiaSolid Tumors
Interventions
DRUG

Campath Purged Non-myeloablative ASCT

"Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Patient Evaluation: Will occur 2-3 times per week by physical exam for toxicity through day 45."

PROCEDURE

Donor Apheresis

Donor will receive Granulocyte colony-stimulating factor (G-CSF) 10-16 mcg/kg/d subcutaneously (dose will be rounded to the nearest whole vial size and may be divided into twice daily dosing). Granulocyte-macrophage colony-stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneous or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.

Trial Locations (1)

27710

Duke University Health Systems, Durham

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Miltenyi Biomedicine GmbH

INDUSTRY

lead

David Rizzieri, MD

OTHER