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Single Treatment With FT1050 of an Ex-vivo Modulated Umbilical Cord Blood Unit

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fate Therapeutics
ClinicalTrials.gov Identifier:
NCT01527838
First received: February 1, 2012
Last updated: May 10, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Non-Hodgkin's Lymphoma (NHL)
Hodgkin's Disease
Chronic Lymphocytic Leukemia (CLL)
Acute Myelogenous Leukemia (AML)
Acute Lymphoblastic Leukemia (ALL)
 Biological: Single FT1050 treated UCB unit
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fate Therapeutics:

Primary Outcome Measures:
  • Neutrophil engraftment/chimerism [ Time Frame: Day 42 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Safety [ Time Frame: Day 100 ] [ Designated as safety issue: Yes ]
    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.

  • Immune reconstitution [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To assess immune reconstitution (B-, T-, and NK-cells).

  • Donor search [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    To determine time from the initiation of donor search to transplantation.


Enrollment: 10
Study Start Date: January 2012
Study Completion Date: May 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single FT1050 treated UCB Unit
Ex-vivo CXCR4 upregulated hematopoietic progenitor cells, cord blood
 Biological: Single FT1050 treated UCB unit
Ex-vivo CXCR4 upregulated hematopoietic progenitor cells, cord blood

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 HLA-matching criteria and has a minimum pre-cryopreservation total nucleated cell (TNC) dose of at least 2.5 x 10^7 cells/kg. Cohort 2 is identical to Cohort 1, except that the TNC dose of the CB unit must be between 2.0 - <2.5 x 10^7 cells/kg. Finally, Cohort 3 is identical to Cohort 2, except that the TNC dose of the CB unit must be between 1.5 - <2.0 x 10^7 cells/kg. If no safety rules are triggered, the study will proceed to the next dosing cohort. Within a dosing cohort, no more than three subjects may be before Day 42 at any one time, unless they have already engrafted neutrophils. The final dosing cohort is defined as the last cohort where 12 evaluable subjects are treated and no stopping rules are triggered. The corresponding TNC dose level will be considered the minimally acceptable TNC dose level.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01527838

Locations
United States, Massachusetts
Dana Farber Cancer Institute-Hematopoietic Stem Cell Transplant Program
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital
Boston, Massachusetts, United States, 02214
United States, Ohio
Ohio State Univeristy Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Fate Therapeutics
Investigators
Study Director: Pratik Multani, MD Fate Therapeutics
  More Information

No publications provided

Responsible Party: Fate Therapeutics
ClinicalTrials.gov Identifier: NCT01527838     History of Changes
Other Study ID Numbers: FT1050-02
Study First Received: February 1, 2012
Last Updated: May 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Fate Therapeutics:
Hematologic malignancies

Additional relevant MeSH terms:
Hodgkin Disease
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Lymphoma
Lymphoma, Non-Hodgkin
Hematologic Neoplasms
 Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Neoplasms by Site
Hematologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013