Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation of Patients With Hematological Diseases

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

November 30, 2002

Primary Completion Date

May 31, 2005

Study Completion Date

December 31, 2006

Conditions
Hematologic Malignancy
Interventions
DRUG

ANTI-CD45

400ug/kg Day-5 through Day-2

DRUG

CAMPATH-1H

Day -8 through Day -6 Dosed per Institutional SOP

DRUG

FK506

Day -2 through Day 30 dose adjusted to maintain level between 5-15 ng/ml.

DRUG

Fludarabine

Day-8 through Day-5 30 mg/m2

RADIATION

Total Body Irradiation

Day-1 single dose 450 cGy

PROCEDURE

Stem cell infusion

Patients will receive peripheral blood stem cells from a HLA matched or one antigen mismatched related or unrelated donor (target CD34+ cell count \>2 x 106/kg). When peripheral stem cells are unavailable or insufficient, bone marrow (target mononuclear cell count \>2 x 108/kg) will be substituted.

Trial Locations (2)

77030

Texas Children's Hospital, Houston

The Methodist Hospital, Houston

All Listed Sponsors
collaborator

The Methodist Hospital Research Institute

OTHER

collaborator

Center for Cell and Gene Therapy, Baylor College of Medicine

OTHER

lead

Baylor College of Medicine

OTHER

NCT00056966 - Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation of Patients With Hematological Diseases | Biotech Hunter | Biotech Hunter