Trial record 1 of 1 for:    NCT01627314
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Trial of a Single ProHema Modulated-CB Unit as Part of a Double CB Transplant in Patients With Hematologic Malignancies.

This study is currently recruiting participants.
Verified April 2014 by Fate Therapeutics
Sponsor:
Information provided by (Responsible Party):
Fate Therapeutics
ClinicalTrials.gov Identifier:
NCT01627314
First received: June 21, 2012
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

This study is an open-label randomized, prospectively and historically controlled trial of the safety and efficacy of a single ProHema-CB unit used as part of a double CB transplant following myeloablative or reduced intensity conditioning for subjects age 15-65 years with hematologic malignancies. A maximum of 60 eligible subjects will be enrolled and treated in the trial at approximately 10 centers within the U.S.


Condition Intervention Phase
Hematologic Malignancies
Biological: ProHema-CB
Biological: Untreated CB
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Controlled Trial of a Single ProHema®-CB Unit (Ex Vivo Modulated Human Cord Blood) As Part of a Double Umbilical Cord Blood Transplant Following Myeloablative or Reduced Intensity Conditioning For Patients Age 15-65 Years With Hematologic Malignancies.

Resource links provided by NLM:


Further study details as provided by Fate Therapeutics:

Primary Outcome Measures:
  • Neutrophil engraftment/chimerism [ Time Frame: before Day 60 ] [ Designated as safety issue: Yes ]
    To determine the rate of neutrophil engraftment after a single ProHema-CB unit is used as part of a double CB transplant.


Secondary Outcome Measures:
  • Neutrophil engraftment [ Time Frame: before Day 180 ] [ Designated as safety issue: No ]
    To define measures of engraftment, including time to neutrophil engraftment, cumulative incidence of neutrophil engraftment by Day 42, time to platelet engraftment (> 20K and > 50K), cumulative incidence of platelet engraftment, and rates of primary and secondary graft failure


Estimated Enrollment: 60
Study Start Date: July 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ProHema-CB Biological: ProHema-CB
Ex-vivo CXCR4 upregulated hematopoietic progenitor cells, cord blood
Active Comparator: Control Arm Biological: Untreated CB
Cord Blood

Detailed Description:

All subjects will receive a myeloablative or reduced intensity conditioning regimen, after which they will receive 2 HLA-matched UCB units. A total of 40 subjects will receive one ProHema-CB as part of a double CB transplant and an additional 20 subjects will be enrolled as concurrent controls. The determination of which CB unit will be the ProHema-CB unit will be made based primarily upon the degree of HLA match.

  Eligibility

Ages Eligible for Study:   15 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:

    • Acute lymphoblastic leukemia (including T lymphoblastic leukemia) in complete remission.
    • Remission is defined as < 5% blasts with no morphological characteristics of acute leukemia in a bone marrow with > 20% cellularity.
    • Acute myelogenous leukemia in high risk first CR or second or subsequent CR.
    • High risk first CR is defined by but is not limited to at least one of the following factors: greater than 1 cycle of induction chemotherapy to achieve CR, prior myelodysplastic syndrome (MDS), presence of Flt3 abnormalities, FAB M6 or M7 subtypes of leukemia, or adverse cytogenetics.
    • Remission is defined as < 5% blasts with no morphological characteristics of acute leukemia (e.g. Auer Rods) in a bone marrow with > 20% cellularity.
    • Biphenotypic/Undifferentiated leukemia in first or subsequent CR (same definition of CR as for ALL/AML).
    • Non-Hodgkin's lymphoma (T-cell, large cell or mantle cell) or Hodgkin's lymphoma in second or subsequent complete remission (CR) or in partial remission (PR) with documented chemosensitivity. In addition, marginal zone lymphoma or follicular lymphoma that has progressed after ≥ 2 therapies (excluding single-agent rituximab). No history of prior myeloablative procedure.
  2. Lack of suitable 5-6/6 HLA-matched related or (if institutional guidelines dictate) suitable 8/8 HLA-A, B, C, DRß1 matched unrelated donor; or unrelated donor not available within appropriate timeframe.
  3. Age 15-65 years.
  4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  5. Signed IRB approved Informed Consent Form (ICF).

Exclusion Criteria:

  1. History of prior allogeneic transplantation
  2. Cardiac disease: symptomatic congestive heart failure or evidence of left ventricular dysfunction (Ejection fraction < 40%) as measured by gated radionuclide ventriculogram or echocardiogram; active angina pectoris, or uncontrolled hypertension; history of myocardial infarction with depressed ejection fraction.
  3. Pulmonary disease: symptomatic chronic obstructive lung disease, symptomatic restrictive lung disease, or corrected DLCO of < 50% of predicted, corrected for hemoglobin.
  4. Renal disease: serum creatinine > 2.0 mg/dl and calculated creatinine clearance < 40 mL/min.
  5. Hepatic disease: serum bilirubin > 2.0 mg/dl (except in the case of Gilbert's syndrome or ongoing hemolytic anemia), SGOT or SGPT > 5 x upper limit of normal.
  6. Neurologic disease: symptomatic leukoencephalopathy, active CNS malignancy or other neuropsychiatric abnormalities believed to preclude transplantation.
  7. HIV antibody.
  8. Uncontrolled infection.
  9. Pregnancy or breast feeding mother.
  10. Inability to comply with the requirements for care after allogeneic stem cell transplantation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01627314

Contacts
Contact: John Ferraro 858-875-1806 john.ferraro@fatetherapeutics.com
Contact: Pratik Multani, M.D. 858-875-1810

Locations
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Principal Investigator: Chatchada Karanes,, MD         
United States, Georgia
Emory University-Winship Cancer Institute Not yet recruiting
Atlanta, Georgia, United States, 30322
Contact: Neera Jagirdar       neera.jagirdar@emory.edu   
Principal Investigator: Edmund Waller, MD         
United States, Massachusetts
Dana-Farber Cancer Institute- Hematopoietic Stem Cell Transplant Program Recruiting
Boston, Massachusetts, United States, 02215
Contact: Kimberly Phillips    617-632-6362    kimberly_phillips@dfci.harvard.edu   
Principal Investigator: Corey Cutler         
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Jami Brown    617-724-9190    jbrown56@partners.org   
Principal Investigator: Karen Ballen         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Jennifer Lay-Luskin         
Principal Investigator: Daniel Couriel, M.D.         
United States, Missouri
Washington University School of Medicine Recruiting
St Louis, Missouri, United States, 63110
Principal Investigator: Peter Westervelt, MD         
United States, New York
Mount Sinai Hospital Recruiting
New York, New York, United States, 10029
Contact: Zachary Galitzeck    212-241-6377    Zachary.galitzeck@mountsinai.org   
Principal Investigator: Luis Isola, MD         
United States, Ohio
Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Amy McGowan    614-293-7374    amy.mcgowan@osumc.edu   
Principal Investigator: Sumithira Vasu, MD         
United States, Oregon
Oregon Health Sciences Recruiting
Portland, Oregon, United States, 97239
Contact: Chelsea Kline       kline@ohsu.edu   
Principal Investigator: Richard Maziarz, MD         
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: NCT01627314     History of Changes
Other Study ID Numbers: FT1050-03
Study First Received: June 21, 2012
Last Updated: April 2, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases

ClinicalTrials.gov processed this record on April 21, 2014