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Safety and Efficacy of ProHema Modulated Umbilical Cord Blood Units in Subjects With Hematologic Malignancies.

This study has been completed.
Sponsor:
Collaborator:
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Fate Therapeutics
ClinicalTrials.gov Identifier:
NCT00890500
First received: April 28, 2009
Last updated: October 7, 2013
Last verified: October 2013

April 28, 2009
October 7, 2013
January 2011
May 2013   (final data collection date for primary outcome measure)
Determine the safety of ProHema modulated umbilical cord blood units when used for transplantation in a reduced intensity, sequential umbilical cord blood transplantation model. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Determine the safety of ex-vivo 16, 16 dimethyl-prostaglandin E2-expanded umbilical cord blood units when used for transplantation in a reduced intensity, sequential umbilical cord blood transplantation model. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00890500 on ClinicalTrials.gov Archive Site
  • Time to engraftment of umbilical cord blood units [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Fractional chimerism of transplanted cord blood units [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Rates of acute and chronic GVHD [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • 30- and 100-day treatment related mortality [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Measures of immune reconstitution and relapse-free and overall survival at 1 and 2 years after transplantation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Time to engraftment of umbilical cord blood units [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Fractional chimerism of transplanted cord blood units [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Rates of acute and chronic GVHD [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • 30- and 100-dat treatment related mortality [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Measures of immune reconstitution and relapse-free and overall survival at 1 and 2 years after transplantation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Efficacy of ProHema Modulated Umbilical Cord Blood Units in Subjects With Hematologic Malignancies.
A Phase I Study of Reduced Intensity, Sequential Double Umbilical Cord Blood Transplantation Using ProHema Modulated Umbilical Cord Blood Units in Subjects With Hematological Malignancies.

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.

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.

-As part of this research study cord units will be modulated in the laboratory with ProHema before it is given to the participant. Two different treatment groups will be tested. Group 1: will have the second cord blood unit modulated with ProHema; Group 2: will have the first cord blood unit modulated with ProHema.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hematologic Malignancies
  • Allogeneic Stem Cell Transplantation
  • Drug: Fludarabine
    30mg/m2/day IV x 6 days
  • Drug: Melphalan
    100 mg/m2/day IV x 1 day
  • Drug: Antithymocyte Globulin
    1mg/kg/day x 4 days
  • Drug: Sirolimus
    GVHD Prophylaxis: Target range 3-12 ng/ml
  • Drug: Tacrolimus
    GVHD Prophylaxis: Target range 5-10 ng/ml
  • Active Comparator: Group 1
    2 umbilical cord units: Second cord blood unit modulated with ProHema
    Interventions:
    • Drug: Fludarabine
    • Drug: Melphalan
    • Drug: Antithymocyte Globulin
    • Drug: Sirolimus
    • Drug: Tacrolimus
  • Active Comparator: Group 2
    2 umbilical cord units: First cord blood unit modulated with ProHema
    Interventions:
    • Drug: Fludarabine
    • Drug: Melphalan
    • Drug: Antithymocyte Globulin
    • Drug: Sirolimus
    • Drug: Tacrolimus
Cutler C, Multani P, Robbins D, Kim HT, Le T, Hoggatt J, Pelus LM, Desponts C, Chen YB, Rezner B, Armand P, Koreth J, Glotzbecker B, Ho VT, Alyea E, Isom M, Kao G, Armant M, Silberstein L, Hu P, Soiffer RJ, Scadden DT, Ritz J, Goessling W, North TE, Mendlein J, Ballen K, Zon LI, Antin JH, Shoemaker DD. Prostaglandin-modulated umbilical cord blood hematopoietic stem cell transplantation. Blood. 2013 Oct 24;122(17):3074-81. doi: 10.1182/blood-2013-05-503177. Epub 2013 Aug 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
October 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00890500
FT1050-01
Yes
Fate Therapeutics
Fate Therapeutics
Dana-Farber Cancer Institute
Principal Investigator: Corey Cutler, MD, MPH, FRCP(C) Dana-Farber Cancer Institute
Fate Therapeutics
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP