Allogeneic Hematopoietic Cell Transplantation for Patients With Busulfex-based Regimen

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

October 31, 2005

Primary Completion Date

November 30, 2015

Study Completion Date

November 30, 2015

Conditions
Chronic Myeloproliferative DisordersLeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic Syndromes
Interventions
BIOLOGICAL

rabbit anti-thymocyte globulin (ATG)

.5 mg/kg on day -3 and 2.5 mg/kg on day -2

BIOLOGICAL

therapeutic allogeneic lymphocytes

minimum total cluster of differentiation (CD34+) cells of 3 x 10\^6 cells/kg and a maximum of 8 x 10\^6 cells/kg will be infused on day 0

DRUG

busulfan

PK-targeted continuous IV infusion over 90 hours on Days -7 to -4.

DRUG

fludarabine phosphate

30 mg/m\^2/day x 5 days intravenous piggyback (IVPB) over 30 minutes on Days -7 through -3

DRUG

tacrolimus

The suggested starting dose is 0.03 mg/kg po bid starting on day -1

PROCEDURE

allogeneic hematopoietic stem cell transplantation

A minimum total CD34+ cell dose of 3 x 10\^6 cells/kg and maximum of 8 x 10\^6 cells/kg will be infused on day 0

PROCEDURE

peripheral blood stem cell transplantation

minimum total CD34+ cell dose of 3 x 10\^6 cells/kg and a maximum of 8 x 10\^6 cells/kg will be infused on day 0

DRUG

methotrexate

5 mg/m\^2 on days +1, +3 and +6

Trial Locations (1)

27599-7295

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill

Sponsors
All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

Otsuka America Pharmaceutical

INDUSTRY

lead

UNC Lineberger Comprehensive Cancer Center

OTHER