Safety and Efficacy of ProHema Modulated Umbilical Cord Blood Units in Subjects With Hematologic Malignancies.
Completed · Phase 1
Conditions studied: Hematologic Malignancies, Allogeneic Stem Cell Transplantation
In brief
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.
Key facts
- Study ID
- NCT00890500
- Run by
- Fate Therapeutics
- People needed
- 12
- Starts
- 2011-01-01
- Expected to finish
- 2013-10-01
- Last updated by the study team
- 2013-10-08
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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