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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%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Myeloablative double unit UCBT | Other | Myeloablative preparative regimen of chemotherapy and radiation followed by double unit umbilical cord blood transplantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cord blood transplantation | Procedure | Myeloablative preparative regimen of chemotherapy and radiation followed by double unit umbilical cord blood transplantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure overall survival of double unit UCBT in adult patients with hematologic malignancies | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Measure incidence of donor-derived neutrophil and platelet recovery | 100 Days | |
| Measure contribution of each unit to initial and sustained engraftment | 2 years | |
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Inclusion Criteria:
Age 22 - 50 years
Patients will have one of the following hematological malignancies:
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:
Patient with suitable related donor
AML, ALL, AUL, biphenotypic leukemia beyond CR2
AML evolved from myelofibrosis
Any acute leukemia with:
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
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| Name | Affiliation | Role |
|---|---|---|
| Juliet Barker, MBBS | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| University of California at Los Angeles |
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| 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 |
| Measure incidence of malignant relapse | 2 years |
| Measure incidence of serious infectious complications | 1 year |
| Measure incidence of immune reconstitution | 2 years |
| Measure probability of overall and disease-free survival | 2 years |
| 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 |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D007938 | Leukemia |
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009370 | Neoplasms by Histologic Type |
| D001855 | Bone Marrow Diseases |
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| ID | Term |
|---|---|
| D036101 | Cord Blood Stem Cell Transplantation |
| ID | Term |
|---|---|
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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