A Phase II Study of Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis in Patients Undergoing Related Donor Hematopoietic Cell Transplantation
1. Suitable related donor as determined by the treating physician.
2. High resolution molecular HLA typing mandatory for HLA Class I and II.
3. Diagnosis of hematological malignancy: Patients with one of the following hematologic
malignancies, and felt to be transplant candidates by their treating physician are
eligible to enroll on this protocol. These hematologic malignancies include:
Non-Hodgkins lymphoma, Hodgkin's disease, AML or ALL, MDS, CML, Multiple Myeloma,
CLL, Myelofibrosis and other myeloproliferative disorders.
4. Age >=18 and able to cooperate with oral medication intake (age>18 for section 7,
immuno-correlative studies due to the volume of the blood draws)
5. Peripheral blood stem cells
6. Agrees to participate, and informed consent signed
7. KPS>60, ECOG performance status <=2
8. Creatinine <2.0 mg/dl or creatinine clearance >50 ml/min
9. Ejection fraction >45%
10. Serum bilirubin, Liver enzymes less than 3 X upper limit of normal
11. Lung function tests >45% predicted
1. Age <18 years and >70 years
2. Bone marrow or Ex vivo engineered or processed graft (CD34+ enrichment, T-cell
3. Patients with documented uncontrolled Central Nervous System disease
4. Active donor or recipient serology positive for human immunodeficiency virus (HIV)
5. Known contraindication to administration of tacrolimus or Thymoglobulin
6. Active Hepatitis B or C
7. Women who are pregnant or nursing..