Status:
COMPLETED
Single Treatment With FT1050 of an Ex-vivo Modulated Umbilical Cord Blood Unit
Lead Sponsor:
Fate Therapeutics
Conditions:
Non-Hodgkin's Lymphoma (NHL)
Hodgkin's Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This trial is a prospective, open-label, single-arm trial of the safety of a single FT1050-treated CB unit for hematopoietic reconstitution after a reduced-intensity conditioning regimen for hematolog...
Detailed Description
The trial will be conducted in three sequential cohorts of 6-12 evaluable subjects each. Cohort 1 will enroll eligible subjects for whom a single CB unit has been identified that meets the minimum HL...
Eligibility Criteria
Inclusion
- Subjects with hematologic malignancies for whom allogeneic stem cell transplantation is deemed clinically appropriate. Eligible diseases and stages include:
- Non-Hodgkin's lymphoma or Hodgkin's lymphoma
- Chronic lymphocytic leukemia (CLL)
- Acute myelogenous leukemia (AML)
- Chronic myelogenous leukemia (CML)
- Lack of 5-6/6 HLA-matched related or 8/8 HLA-A, B, C, DRß1 matched unrelated donor; or unrelated donor not available within appropriate timeframe.
- Identification of suitable backup CB unit(s) (single unit with pre-cryopreservation cell dose ≥ 2.5 x 10\^7 TNC/kg or two units with pre-cryopreservation cell dose ≥ 1.5 x 10\^7 TNC/kg each) and meeting minimum HLA match criteria.
- An acceptable alternative to one or two backup CB unit(s) is the identification of an eligible related haploidentical donor that meets minimum HLA match criteria.
- Age 18-65 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Signed IRB approved Informed Consent Form (ICF).
Exclusion
- The following hematologic malignancies are excluded:
- Myelofibrosis (Agnogenic Myeloid Metaplasia)
- Aplastic anemia.
- Previous treatment that included an allogeneic transplant
- Cardiac disease: symptomatic congestive heart failure or evidence of left ventricular
- dysfunction (Ejection fraction \< 40%) as measured by gated radionucleotide ventriculogram or echocardiogram; active angina pectoris, or uncontrolled hypertension; history of myocardial infarction with depressed ejection fraction.
- Pulmonary disease: symptomatic chronic obstructive lung disease, symptomatic restrictive lung disease, or corrected DLCO of \< 50% of predicted, corrected for hemoglobin.
- Renal disease: serum creatinine \> 2.0 mg/dl and calculated creatinine clearance \< 40 mL/min
- Hepatic disease: serum bilirubin \> 2.0 mg/dl (except 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.
- Participation in a concurrent clinical trial with a novel, unapproved investigational agent \< 30 days prior to Day 0.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01527838
Start Date
January 1 2012
End Date
November 1 2013
Last Update
September 12 2016
Active Locations (3)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02214
2
Dana Farber Cancer Institute-Hematopoietic Stem Cell Transplant Program
Boston, Massachusetts, United States, 02215
3
Ohio State Univeristy Comprehensive Cancer Center
Columbus, Ohio, United States, 43210