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
PHASE2
56 participants
INTERVENTIONAL
2007-08-31
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Myeloablative double unit UCBT
Myeloablative preparative regimen of chemotherapy and radiation followed by double unit umbilical cord blood transplantation
Cord blood transplantation
Myeloablative preparative regimen of chemotherapy and radiation followed by double unit umbilical cord blood transplantation
Interventions
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Cord blood transplantation
Myeloablative preparative regimen of chemotherapy and radiation followed by double unit umbilical cord blood transplantation
Eligibility Criteria
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Inclusion Criteria
* Patients will have one of the following hematological malignancies:
* Acute myelogenous leukemia (AML): Complete first remission (CR1) at high risk for relapse or Complete second remission (CR2)
* Acute lymphoblastic leukemia (ALL): Complete first remission (CR1) at high risk for relapse or Complete second remission (CR2)
* Acute undifferentiated leukemia (AUL) or biphenotypic leukemia: CR1 or CR2
* Myelodysplastic Syndrome (MDS) with one of the following: Low and Intermediate-1 International Prognostic Scoring System (IPSS) score with Life-threatening neutropenia or thrombocytopenia; or Platelet transfusion dependence Intermediate-2 or High IPSS score Therapy-related disease: patient with history of chemotherapy and current evidence of MDS
* Patients with adequate organ function and performance status criteria
* Two Suitable Umbilical Cord Blood Units: a cryopreserved dose of at least 1.5 x 107 TNC/kg. If the unit contains red cells at time of cryopreservation, the cryopreserved dose must be at least 2.0 x 107 TNC/kg. Each unit must be at least 4/6 HLA-A and B antigen, and DRB1 allele matched with the recipient. Each unit must be at least 3/6 HLA-A, B DRB1 antigen matched to each other.
Exclusion Criteria
* AML, ALL, AUL, biphenotypic leukemia beyond CR2
* AML evolved from myelofibrosis
* Any acute leukemia with:
* Morphologic relapse or persistent disease in the BM
* Active extra-medullary leukemia including active CNS leukemia
* Requiring greater than two cycles of chemotherapy to obtain present remission status
* Bone marrow aplasia (defined as BM cellularity \< 5% at transplant work-up)
* MDS with 10% or greater bone marrow blasts at pre-transplant workup
* Prior autologous or allogeneic HSC transplant at any time
* Prior radiation therapy rendering patient ineligible for TBI
* Any uncontrolled infection at time of study enrollment
* Seropositive or NAT positive for HIV or HTLV1
* Females who are pregnant or breast feeding
* Patient unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, follow-up, and research tests
22 Years
50 Years
ALL
No
Sponsors
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Center for International Blood and Marrow Transplant Research
NETWORK
Responsible Party
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Principal Investigators
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Juliet Barker, MBBS
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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City of Hope
Duarte, California, United States
University of California at Los Angeles
Los Angeles, California, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Blood and Marrow Transplant Program at Northside Hospital
Atlanta, Georgia, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Case Western Reserve University
Cleveland, Ohio, United States
Ohio State University Medical Center
Columbus, Ohio, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
University of Wisconsin-Madison
Madison, Wisconsin, United States
Countries
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Other Identifiers
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05-DCB
Identifier Type: -
Identifier Source: org_study_id
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