Allogeneic Cord Blood Transplantation

Pilot Trial Of Allogeneic Cord Blood Transplantation For Patients With Advanced Hematologic Disorders Using A Combination Of Unexpanded Cells And Cells Expanded Ex-Vivo

Objectives:

1. To assess the safety of the mixture of early-, mid-, and late-stage allogeneic cord blood derived mononuclear cells produced in the Aastrom Cell Production System when infused into patients with advanced hematologic disorders.

2. To determine the biological effect in terms of hematopoietic recovery after infusion of ex-vivo produced hematopoietic cells following high dose chemotherapy and radiotherapy as treatment of patients with advanced hematologic malignancies.

3. To record the clinical disease related outcome in these patients with advanced hematologic disorders i.e., clinical tumor response, duration of responses, and disease free duration post high dose therapy.

Treatment:

1. Selection of cord blood donor (after trying to search the NMDP for an unrelated allo-donor.

2. Preparative regimen:

* The primary preparative regimen will be cyclophosphamide and TBI. For patients ineligible to receive TBI (previous radiation), patients will receive busulfan and cyclophosphamide.

3. Cord blood infusion (after expansion).

Eligibility:

INITIAL INCLUSION / EXCLUSION:

1. The patient must have a disease for which a transplant is considered the only option for meaningful therapy other than treatments offered for palliation of symptoms. Requirements include: Lack of an HLA-compatible related donor, inability to find a donor in a timely manner, or a disease for which an autologous transplant is not considered to be a potentially curative option.

2. HLA A, B, and DR 3/6, 4/6, 5/6, or 6/6 HLA compatible donor obtained through one of the cord blood banks established in the United States.

3. Age <= 55.

4. Includes the following disorders:

* AML, ALL, CML, Myelodysplasia, Severe Aplastic Anemia, any hematologic malignancy that has relapsed after an autologous marrow / blood stem cell transplant, congenital severe hematologic abnormality such as Fanconi’s anemia, or any other hematologic malignancy or pre-malignancy such as myelofibrosis or lymphoma.

5. No evidence of acute, uncontrolled viral, fungal, or bacterial infection.

6. Cardiac ejection fraction (LVEF) >= 45%.

7. DLCO or FEVI >= 60% of predicted.

8. Serum bilirubin <=3.0 unless due to an underlying condition; SGOT/PT <=3 x ULN unless due to an underlying condition; creatinine clearance >=60 ml/min.

9. No evidence of active meningeal or CNS leukemia or uncontrolled infection.