Adult Double Cord Blood Transplant Study
A Phase II Multicenter Trial of Myeloablative Double Unit Umbilical Cord Blood Transplantation (UCBT) in Adults With Hematologic Malignancy
1 other identifier
interventional
56
1 country
10
Brief Summary
The hypothesis of the study is double unit umbilical cord blood transplantation in adults will be associated with a one year survival rate of at least 40%.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2007
Longer than P75 for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 8, 2007
CompletedFirst Posted
Study publicly available on registry
August 10, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedMarch 10, 2014
March 1, 2014
6 years
August 8, 2007
March 7, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measure overall survival of double unit UCBT in adult patients with hematologic malignancies
One year
Secondary Outcomes (9)
Measure incidence of donor-derived neutrophil and platelet recovery
100 Days
Measure contribution of each unit to initial and sustained engraftment
2 years
Measure incidence and severity of acute graft-versus-host disease
100 Days
Measure incidence and severity of chronic GVHD
1 year
Measure incidence of transplant-related mortality
6 months
- +4 more secondary outcomes
Study Arms (1)
Myeloablative double unit UCBT
OTHERMyeloablative preparative regimen of chemotherapy and radiation followed by double unit umbilical cord blood transplantation
Interventions
Myeloablative preparative regimen of chemotherapy and radiation followed by double unit umbilical cord blood transplantation
Eligibility Criteria
You may qualify if:
- Age 22 - 50 years
- 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.
You may not qualify if:
- Patient with suitable related donor
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
City of Hope
Duarte, California, 91010, United States
University of California at Los Angeles
Los Angeles, California, 90095, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
Blood and Marrow Transplant Program at Northside Hospital
Atlanta, Georgia, 30342, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
University of Wisconsin-Madison
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Juliet Barker, MBBS
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2007
First Posted
August 10, 2007
Study Start
August 1, 2007
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
March 10, 2014
Record last verified: 2014-03