Hodgkin's Disease Clinical Trial
Official title:
A Phase I Trial of a Single FT1050 (16,16-Dimethyl Prostaglandin E2) Ex Vivo-Modulated Umbilical Cord Blood (CB) Unit Following a Reduced Intensity Conditioning Regimen For Adults With Hematologic Malignancies
Verified date | January 2015 |
Source | Fate Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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 hematologic malignancies. A maximum of 40 eligible adult subjects will be enrolled and treated in the trial at approximately 2-4 centers within the U.S.
Status | Completed |
Enrollment | 10 |
Est. completion date | November 2013 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. 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) 2. 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. 3. Age 18-65 years. 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. 5. Signed IRB approved Informed Consent Form (ICF). Exclusion Criteria: 1. The following hematologic malignancies are excluded: - Myelofibrosis (Agnogenic Myeloid Metaplasia) - Aplastic anemia. 2. Previous treatment that included an allogeneic transplant 3. Cardiac disease: symptomatic congestive heart failure or evidence of left ventricular 4. 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. 5. Pulmonary disease: symptomatic chronic obstructive lung disease, symptomatic restrictive lung disease, or corrected DLCO of < 50% of predicted, corrected for hemoglobin. 6. Renal disease: serum creatinine > 2.0 mg/dl and calculated creatinine clearance < 40 mL/min 7. 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. 8. Neurologic disease: symptomatic leukoencephalopathy, active CNS malignancy or other neuropsychiatric abnormalities believed to preclude transplantation. 9. HIV antibody. 10. Uncontrolled infection. 11. Pregnancy or breast feeding mother. 12. Inability to comply with the requirements for care after allogeneic stem cell transplantation. 13. Participation in a concurrent clinical trial with a novel, unapproved investigational agent < 30 days prior to Day 0. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Dana Farber Cancer Institute-Hematopoietic Stem Cell Transplant Program | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Ohio State Univeristy Comprehensive Cancer Center | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Fate Therapeutics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Neutrophil engraftment/chimerism | To determine the minimally effective TNC dose for a single FT1050-treated CB unit based on neutrophil engraftment/chimerism when used for hematopoietic reconstitution following a reduced-intensity conditioning regimen for hematologic malignancies. | Day 42 | No |
Secondary | Safety | Define the safety profile of treatment with a single FT1050-treated CB unit. To define the preliminary efficacy of treatment with a single FT1050-treated CB unit. | Day 100 | Yes |
Secondary | Immune reconstitution | To assess immune reconstitution (B-, T-, and NK-cells). | 2 years | No |
Secondary | Donor search | To determine time from the initiation of donor search to transplantation. | Day 0 | No |
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