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| Name | Class |
|---|---|
| Dana-Farber Cancer Institute | OTHER |
The purpose of this study is to determine the safety of sequential cord blood transplantation (2 cord blood units) for patients who have diseases that are capable of being cured by allogeneic stem cell transplant but do not have a matched family or volunteer unrelated donor.
Eligible patients will receive conditioning therapy with fludarabine 30 mg/m2/day x 6 days, melphalan 100 mg/m2/day x 1 day, rabbit antithymocyte globulin 1.5 mg/kg/day x 4 days. GVHD prophylaxis will consist of cyclosporine starting on day -1 and mycophenolate mofetil starting on day 0. Sequential cord blood units will be infused on Day 0.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sequential cord blood transplantation | Procedure | Infused on Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the 100-day transplant-related (non-relapse) mortality, including relapse-related mortality associated with Grade 4 toxicity. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the 6 month transplant related (non-relapse) mortality. | 3 years | |
| To evaluate the days to neutrophil engraftment (ANC > 500). | 3 years | |
| To evaluate the days of platelet engraftment (platelet count > 20K unsupported). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Ballen, M.D. | Massachusetts General Hospital, Harvard University | Principal Investigator |
| Joseph Antin, M.D. | Dana Farber Cancer Institute, Harvard Univeristy | Principal Investigator |
| David Avigan, M.D. | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States | ||
| Massachusetts General Hospital |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D007938 | Leukemia |
| D009101 | Multiple Myeloma |
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| 3 years |
| To evaluate the risk of acute and chronic graft versus host disease. | 3 years |
| To evaluate percent donor chimerism - contribution of each cord unit. | 3 years |
| To evaluate relapse rate. |
| To evaluate overall survival. |
| To evaluate transfusion support needed to cord blood transplant recipients. | 3 years |
| Boston |
| Massachusetts |
| 02116 |
| United States |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006402 | Hematologic Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D001855 | Bone Marrow Diseases |