Safety and Efficacy of ProHema Modulated Umbilical Cord Blood Units in Subjects With Hematologic Malignancies.
NCT ID: NCT00890500
Last Updated: 2013-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2011-01-31
2013-10-31
Brief Summary
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Detailed Description
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-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.
Conditions
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Study Design
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NON_RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Group 1
2 umbilical cord units: Second cord blood unit modulated with ProHema
Fludarabine
30mg/m2/day IV x 6 days
Melphalan
100 mg/m2/day IV x 1 day
Antithymocyte Globulin
1mg/kg/day x 4 days
Sirolimus
GVHD Prophylaxis: Target range 3-12 ng/ml
Tacrolimus
GVHD Prophylaxis: Target range 5-10 ng/ml
Group 2
2 umbilical cord units: First cord blood unit modulated with ProHema
Fludarabine
30mg/m2/day IV x 6 days
Melphalan
100 mg/m2/day IV x 1 day
Antithymocyte Globulin
1mg/kg/day x 4 days
Sirolimus
GVHD Prophylaxis: Target range 3-12 ng/ml
Tacrolimus
GVHD Prophylaxis: Target range 5-10 ng/ml
Interventions
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Fludarabine
30mg/m2/day IV x 6 days
Melphalan
100 mg/m2/day IV x 1 day
Antithymocyte Globulin
1mg/kg/day x 4 days
Sirolimus
GVHD Prophylaxis: Target range 3-12 ng/ml
Tacrolimus
GVHD Prophylaxis: Target range 5-10 ng/ml
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Dana-Farber Cancer Institute
OTHER
Fate Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Corey Cutler, MD, MPH, FRCP(C)
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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References
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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.
Other Identifiers
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FT1050-01
Identifier Type: -
Identifier Source: org_study_id