Status:
COMPLETED
Safety and Efficacy of ProHema Modulated Umbilical Cord Blood Units in Subjects With Hematologic Malignancies.
Lead Sponsor:
Fate Therapeutics
Collaborating Sponsors:
Dana-Farber Cancer Institute
Conditions:
Hematologic Malignancies
Allogeneic Stem Cell Transplantation
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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 u...
Detailed Description
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 u...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00890500
Start Date
January 1 2011
End Date
October 1 2013
Last Update
October 8 2013
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115