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| ID | Type | Description | Link |
|---|---|---|---|
| CA23766 | |||
| CA33049 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
This is a phase II, single-center study to evaluate the efficacy of a novel cytoreductive regimen followed by CD34+E- selected T cell depleted allogeneic stem cell (or soybean agglutinated and E-rosetted BM) transplant as treatment for patients with acute and chronic leukemias, lymphoma and myelodysplstic syndrome/PNH. The impact of the change in conditioning regimen and use of CD34-selected T cell depleted PBSCs on transplanted related morbidity and mortality and disease free survival will be assessed.
The purpose of this study is: (1) to try to kill any cancer or precancer cells that are in your body, and to reduce the side effects of a transplant, which we have seen in our previous studies, (2) to see if this treatment with a new recipe of radiation and chemotherapy can suppress your immune system enough for the stem cells to 'take' and grow, (3) to see if the specially prepared stem cells can grow in you without a problem called graft-versus-host disease (GvHD) occurring.
One of the major side effects of any stem cell transplant is a condition known as graft vs. host disease or GVHD. GVHD is an immune reaction caused by certain cells from the transplanted stem cells called T-lymphocytes (or T-cells). The T-cells from your donor may see your organs as foreign and attack them. New ways to remove the T-cells from the stem cells before the transplant are being used to try and prevent GVHD. In some studies, the removal of T-cells from the stem cells has been successful for many patients in preventing both short-term (acute) and long-term (chronic) forms of GVHD. However, the removal of T-cells may increase the chance that the new bone marrow developing from the stem cells will be rejected or will not function well. Rejection of the transplant means that some of your own cells have survived the chemo and radiation therapy, and are attacking the new bone marrow cells. This condition can be lifethreatening because of an increased risk of infections and bleeding and would require your getting more treatment and additional stem cells. Studies like this one are designed to find better ways to avoid GVHD without increasing the risk of other problems such as graft rejection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transplant Patients | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cytoreductive regimen followed by a CD34+E- selected allogeneic stem cell transplant | Drug | Myeloablative and will consist of hyperfractionated TBI - 1375 cGy administered in 11 doses of 125 cGy each over a total of four days, with three doses on three days and two doses on the last day, fludarabine 25 mg/m2 IV x 5 days, and thiotepa 5mg/kg IV x 2 days. Recipients of HLA identical related transplants will not receive ATG to promote engraftment. Recipients of HLA mismatched related or unrelated stem cells will receive ATG for two days prior to the transplant. G-CSF mobilized CD34+E- PBSCs obtained from the HLA compatible donor will be infused on day 0. Post transplantation G-CSF will be administered only if clinically indicated and should begin on or after d+7. Patients will be clinically evaluated at each clinic visit for incidence and severity of acute and chronic GVHD and transplant associated morbidity. Sequential evaluation of functional reconstitution of hematopoiesis and immunity will be made as per the BMT Service guidelines. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival of Transplant Patients | Calculate the median overall survival of transplant patients | up to 6 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann Jakubowski, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan-Kettering web site | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Transplant Patients | Adult Patients (>18 years) with Lymphohematopoietic Disorders will receive Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplants After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Transplant Patients | Adult Patients (>18 years) with Lymphohematopoietic Disorders will receive Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplants After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Survival of Transplant Patients | Calculate the median overall survival of transplant patients | Posted | Median | Full Range | Days | up to 6 years |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Transplant Patients | Adult Patients (>18 years) with Lymphohematopoietic Disorders will receive Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplants After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine | 13 | 129 | 126 | 129 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adult respiratory disorder | Respiratory, thoracic and mediastinal disorders | CTC-2.0 | Systematic Assessment |
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| Left ventricular failure | Cardiac disorders | CTC-2.0 | Systematic Assessment |
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| Constitutional symptoms, other | General disorders | CTC-2.0 | Systematic Assessment |
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| Hemorrhage, other | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
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| Hypoxia | Musculoskeletal and connective tissue disorders | CTC-2.0 | Systematic Assessment |
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| infection unknown absolut neutriphil counts | Infections and infestations | CTC-2.0 | Systematic Assessment |
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| Infection without neutropenia | Infections and infestations | CTC-2.0 | Systematic Assessment |
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| Leukoencephalopathy | Nervous system disorders | CTC-2.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | CTC-2.0 | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | CTC-2.0 | Systematic Assessment |
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| Seizure | Nervous system disorders | CTC-2.0 | Systematic Assessment |
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| Vision-double vision | Eye disorders | CTC-2.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alkaline phosphatase | Metabolism and nutrition disorders | CTC-2.0 | Systematic Assessment |
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| Bilirubin | Metabolism and nutrition disorders | CTC-2.0 | Systematic Assessment |
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| Creatinine | Metabolism and nutrition disorders | CTC-2.0 | Systematic Assessment |
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| Hemoglobin (Hgb) | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | CTC-2.0 | Systematic Assessment |
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| Hyperkalemia | Metabolism and nutrition disorders | CTC-2.0 | Systematic Assessment |
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| Hypocalcemia | Metabolism and nutrition disorders | CTC-2.0 | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | CTC-2.0 | Systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | CTC-2.0 | Systematic Assessment |
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| Hypophosphatemia | Metabolism and nutrition disorders | CTC-2.0 | Systematic Assessment |
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| Leukocytes | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
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| Neutrophils | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
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| Platelets | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
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| Prothrombin time (PT) | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
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| Partial thromboplastin time (PTT) | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
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| SGOT (AST) | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
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| SGPT (ALT) | Blood and lymphatic system disorders | CTC-2.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ann Jakubowski | Memorial Sloan-Kettering Cancer Center | 212-639-5013 | jakubowa@mskcc.org |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D009190 | Myelodysplastic Syndromes |
| D006457 | Hemoglobinuria, Paroxysmal |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001855 | Bone Marrow Diseases |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
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