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Sponsored by: |
Rocky Mountain Blood and Marrow Transplant Program |
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Information provided by: | Rocky Mountain Blood and Marrow Transplant Program |
ClinicalTrials.gov Identifier: | NCT00328237 |
The purpose of this study is to evaluate the incidence of neutrophil engraftment after transplantation of one or two cord blood units meeting a predetermined total minimum cell dose of 2.0 x 10 to the seventh total nucleated cell (TNC)/kg.
Condition | Intervention | Phase |
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Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Chronic Myeloid Leukemia Non-Hodgkin Lymphoma Myelodysplastic Syndromes |
Procedure: Cord Blood Transplant |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Treatment of Hematologic Malignancies With High-Dose Chemo-Radiotherapy Followed by Single-Unit or Double-Unit Cord Blood Transplantation: A Phase II Study |
Estimated Enrollment: | 20 |
Study Start Date: | November 2005 |
This is a non-randomized, phase II protocol to evaluate engraftment of cord blood after treatment with myeloablative conditioning of fludarabine, total body irradiation and cyclophosphamide. All patients will receive tacrolimus and mycophenolate mofetil as prophylaxis for graft-vs-host disease.
Conditioning Regimen:
Day 0: Infusion of Cord Blood Cells
Graft-vs-Host Disease Prophylaxis
Ages Eligible for Study: | 18 Years to 49 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must:
Have histologically proven hematologic malignancy and must meet accepted indications for allogeneic stem cell transplantation:
Exclusion Criteria:
Patients are ineligible for this protocol if they:
Patients with any of the following will be excluded:
Contact: Nicole Stephens, RN, BSN, OCN | 303-336-2183 | Nicole.Stephens@USOncology.com |
Contact: Juli Murphy, CCRC | 303-285-5087 | Juli.Murphy@USOncology.com |
United States, Colorado | |
Rocky Mountain Blood and Marrow Transplant Program | Recruiting |
Denver, Colorado, United States, 80218 | |
Sub-Investigator: Scott Bearman, MD | |
Sub-Investigator: Robert Rifkin, MD | |
Sub-Investigator: Mark Brunvand, MD | |
Sub-Investigator: Jeffrey Matous, MD | |
Sub-Investigator: Michael Maris, MD |
Principal Investigator: | Peter McSweeney, MD | Rocky Mountain Blood and Marrow Transplant Program |
Study ID Numbers: | RMBMT-149 |
Study First Received: | May 17, 2006 |
Last Updated: | June 23, 2006 |
ClinicalTrials.gov Identifier: | NCT00328237 |
Health Authority: | United States: Institutional Review Board |
Cord Blood Transplant Umbilical cord blood transplant Transplant |
Fludarabine Total Body Irradiation Cyclophosphamide |
Leukemia, Lymphoid Hematologic Neoplasms Precancerous Conditions Chronic myelogenous leukemia Lymphoma, small cleaved-cell, diffuse Cyclophosphamide Leukemia, Myeloid, Acute Leukemia Preleukemia Lymphoma Acute myelocytic leukemia Myelodysplastic syndromes Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders |
Hematologic Diseases Myelodysplastic Syndromes Myelodysplasia Myeloproliferative Disorders Acute myelogenous leukemia Fludarabine monophosphate Leukemia, Myeloid Lymphatic Diseases Leukemia, Myelogenous, Chronic, BCR-ABL Positive Fludarabine Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Bone Marrow Diseases |
Neoplasms Neoplasms by Site Pathologic Processes Disease |
Neoplasms by Histologic Type Immune System Diseases Syndrome |