Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a phase II study to assess the day 180 event free and overall survival after administration of a specified combination of fludarabine, busulfan, Total Body Irradiation (TBI), and thymoglobulin reduced intensity conditioning and 2 unit UCB stem cell transplant in a single institution setting in patients with hematologic malignancies for whom allogeneic transplantation is indicated.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reduced Intensity Conditioning with UCB Transplant | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fludarabine | Drug | 35 mg/m2 IV/day x 5 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Event Free Survival | Number of subjects surviving with no events at 180 days post transplantation (Day 0). | 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Transplant Engraftment | Number of patients with successful UCB engraftment. | Day 42 |
| Incidence of Graft-versus-host disease (GVHD) | Number of patients that experience acute or chronic GVHD. |
Not provided
Inclusion Criteria:
Subjects 18-70 years old. ECOG 0-2
Patients must have a diagnosis of one of the following:
Patients must have adequate visceral organ function
Exclusion Criteria:
Patients who are HIV or HTLV-I, -II antibody sero-positive are ineligible.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Amer M Beitinjaneh, MD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 15, 2016 | |
| Reset | Feb 12, 2016 | |
| Release | Nov 18, 2016 | |
| Reset | Jan 13, 2017 | |
| Release | Feb 17, 2017 | |
| Reset | Apr 4, 2017 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 15, 2016 | Feb 12, 2016 | |||
| Nov 18, 2016 |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D015470 | Leukemia, Myeloid, Acute |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D008228 | Lymphoma, Non-Hodgkin |
| D006689 | Hodgkin Disease |
| D009190 | Myelodysplastic Syndromes |
| D009196 | Myeloproliferative Disorders |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C024352 | fludarabine |
| D002066 | Busulfan |
| C512542 | thymoglobulin |
| D014916 | Whole-Body Irradiation |
| ID | Term |
|---|---|
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Busulfan |
| Drug |
.8 mg/kg IV Q6h x 8 doses |
|
| Thymoglobulin | Drug | 1.5 mg/kg/day x 3 days |
|
| Total Body Irradiation | Radiation | 150 cGy for 2 days |
|
| Umbilical Cord Blood | Biological | Two partially HLA-matched UCB units. Each unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient. |
|
| 1 year |
| Time course for peripheral blood chimerism. | Percent of patients with >95% donor chimerism. | 56 days |
| Incidence of secondary lymphoproliferative diseases | Number of patients with secondary lymphoproliferative diseases. | 6 months |
| Incidence of disease recurrence | Number of patients experience disease recurrence. | Up to two years |
| Incidence of serious infectious complications | Number of patients experiencing serious infectious complications. | 1 year |
| Overall Survivals | Number of patient with overall event free survival and overall survival distributions. | 60 months |
| Jan 13, 2017 |
| Feb 17, 2017 | Apr 4, 2017 |
| D007951 |
| Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D001855 | Bone Marrow Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008223 | Lymphoma |
| D008698 |
| Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |