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| ID | Type | Description | Link |
|---|---|---|---|
| L 10,394 | Other Identifier | New York Medical College |
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Allogeneic stem cell transplantation followed by targeted immune therapy with Gemtuzumab Ozogamicin (Mylotarg) will be given to patients with average risk AML or MDS.
Reduced intensity conditioning regimen of Busulfan (Bu) and Fludarabine (Flu) + Anti-Thymocyte Globulin (ATG ) (unrelated donors only) or reduced toxicity conditioning regimen of Bu/Flu/alemtuzumab, or reduced hepatic toxicity regimen of melphan/Flu/alemtuzumab and AlloSCT, followed by Gemtuzumab Ozogamicin consolidation in patients with average risk AML/MDS meeting eligibility criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemtuzumab Ozogamicin | Experimental | Consolidation therapy with GO will be administered between days 60 and 180 post transplantation when the ANC is >1000/mm3 and platelet count is >40,000/mm3 untransfused x 3 days after AlloSCT and again at minimum 8 weeks later. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemtuzumab Ozogamicin | Drug | Gemtuzumab, 9.0 mg/m2, will be given IV over 2 hours two times post allogeneic transplantation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| to evaluate incidence of graft failure | If three or more of the first ten patients experience primary or secondary graft failure, we will discontinue the study. | Day +42 |
| to evaluate survival rates | Event-free survival and overall survival after RI AlloSCT and targeted immunotherapy in patients with average risk AML/MDS. | 1 year |
| to determine toxicity | to monitor for serious adverse events related to protocol investigational therapy | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Minor histocompatibility antigen | To measure the minor histocompatibility antigen expression on AML tissue, donor and recipient, and the development of MHA specific CTLs post AlloSCT. | 1 year |
| Chimerism |
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Inclusion Criteria:
Disease Status:
Disease Immunophenotype:
Organ Function:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mitchell S. Cairo, M.D. | New York Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Medical College | Valhalla | New York | 10595 | United States |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000079982 | Gemtuzumab |
| ID | Term |
|---|---|
| D000080084 | Calicheamicins |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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To determine the degree of mixed/complete donor chimerism after RI AlloSCT in patients with average risk AML/MDS.
| 1 year |
| Graft-versus-host disease | To estimate the risk of acute and chronic GVHD following RI AlloSCT and FK506/MMF GVHD prophylaxis in patients with average risk AML/MDS. | 1 Year |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |
| D061067 |
| Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |