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
  Purpose

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.


Condition Intervention Phase
Hematologic Malignancies
Allogeneic Stem Cell Transplantation
Drug: Fludarabine
Drug: Melphalan
Drug: Antithymocyte Globulin
Drug: Sirolimus
Drug: Tacrolimus
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Fate Therapeutics:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 12
Study Start Date: January 2011
Study Completion Date: October 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1
2 umbilical cord units: Second cord blood unit modulated with ProHema
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 2
2 umbilical cord units: First cord blood unit modulated with ProHema
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

Detailed Description:

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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00890500

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Fate Therapeutics
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Corey Cutler, MD, MPH, FRCP(C) Dana-Farber Cancer Institute
  More Information

No publications provided by Fate Therapeutics

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fate Therapeutics
ClinicalTrials.gov Identifier: NCT00890500     History of Changes
Other Study ID Numbers: FT1050-01
Study First Received: April 28, 2009
Last Updated: October 7, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases
Antilymphocyte Serum
Melphalan
Fludarabine monophosphate
Sirolimus
Tacrolimus
Fludarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Myeloablative Agonists
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antibiotics, Antineoplastic
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 22, 2014