Safety and Efficacy of ProHema Modulated Umbilical Cord Blood Units in Subjects With Hematologic Malignancies.

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research study is to determine the safety and efficacy of a reduced intensity conditioning regimen during a double umbilical cord blood unit transplant with one of the cord blood units modulated with ProHema.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fate Therapeutics
• Collaborator: Dana-Farber Cancer Institute
• Treatments: Antilymphocyte Serum; Fludarabine; Melphalan; Sirolimus; Tacrolimus

Criteria

Inclusion Criteria:

• Patients with hematologic malignancies for whom allogeneic stem cell transplantation is deemed clinically appropriate

• Patient must be ineligible for traditional myeloablative transplantation according to treating physician

• Lack of 6/6 or 5/6 HLA-matched related, 8/8 HLA-matched unrelated donor, or unrelated donor not available within a time frame necessary to perform a potentially curative stem cell transplant

• 18-65 years of age

• ECOG Performance Status 0-2

Exclusion Criteria:

• The following hematologic malignancies are excluded:

• Myelofibrosis unless there has been exposure to cytotoxic chemotherapy for the treatment of progression to acute myeloid leukemia

• Chronic Myelogenous Leukemia, unless there has been exposure to cytotoxic chemotherapy for the treatment of blast phase, 3) Aplastic anemia, in the absence of transformation to Myelodysplastic disorder

• Cardiac disease: symptomatic congestive heart failure or evidence of left ventricular dysfunction as measured by gated radionucleotide ventriculogram or echocardiogram; active angina pectoris, or uncontrolled hypertension

• Pulmonary disease: symptomatic chronic obstructive lung disease, symptomatic restrictive lung disease, or corrected DLCO of < 50% of predicted, corrected hemoglobin

• Renal disease: serum creatinine > 2.0mg/dl

• Hepatic disease: serum bilirubin > 2.0mg/dl (expect in the case of Gilbert's syndrome or ongoing hemolytic anemia), SGOT or SGPT > 3 x upper limit of normal

• Neurologic disease: symptomatic leukoencephalopathy, active CNS malignancy or other neuropsychiatric abnormalities believed to preclude transplantation

• HIV antibody

• Uncontrolled infection

• Pregnancy or breast feeding mother

• Inability to comply with the requirements for care after allogeneic stem cell transplantation