| Last Verified: | November/30/2017 |
| First Submitted: | October/24/2006 |
| Estimated Enrollment Submitted: | October/24/2006 |
| First Posted: | October/25/2006 |
| Last Update Submitted: | December/2/2017 |
| Last Update Posted: | December/27/2017 |
| : | June/14/2011 |
| : | June/14/2011 |
| : | July/14/2011 |
| Actual Study Start Date: | June/30/2005 |
| Estimated Primary Completion Date: | April/30/2011 |
| Estimated Study Completion Date: | April/30/2011 |
Myelodysplastic Syndromes
| Study Type: | Interventional |
| Allocation: | N/A |
| Primary Purpose: | Treatment |
| Masking: | None (Open Label) |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Natural Killer Cell Kir Epitope | Biological: Natural Killer Cell Kir Epitope Rabbit thymoglobulin will be given intravenously at a dose of 2.5 mg/kg on days -5,-4, -3, and -2. The first dose of thymoglobulin will be given over six (6) hours and subsequent doses over four (4) or more hours as tolerated or, per institutional anti-thymocyte globulin (ATG) administration guidelines. |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Criteria: | Inclusion Criteria: - Primary acute myeloid leukemia (AML) - First complete remission (CR) with high risk features as defined by: failure to achieve remission by day 21 after induction chemotherapy, or the presence of chromosomal abnormalities involving any of the following: -5/de (5q), -7/del(7q), inversion 3q, abnormalities of 11q23, 20q, 21q, del(9q), translocation 6;9, translocation 9;22, abnormalities of 17p, or complex karyotype with > or = 3 abnormalities. Complete remission is defined as < 5% blasts in the marrow. - Second CR or subsequent in remission - Refractory or relapsed disease with absolute peripheral blood blasts < 2000/mcL - Secondary AML in remission or relapse - Chronic myelogenous leukemia (CML) in accelerated or blast phase - Accelerated phase is defined by any one of the following: - Blasts 10% to 19% of peripheral blood white cells or bone marrow cells - Peripheral blood basophils at least 20% - Persistent thrombocytopenia (<100 x 10^9/L) unrelated to therapy, or persistent thrombocytosis (>1000 x 10^9/L) unresponsive to therapy - Increasing spleen size and increasing white blood cell (WBC) count unresponsive to therapy - Cytogenetic evidence of clonal evolution (i.e., the appearance of an additional genetic abnormality that was not present in the initial specimen at the time of diagnosis of chronic phase CML) - Resistance to tyrosine kinase inhibitors (imatinib or other) defined as no complete cytogenetic response even if the above criteria are not met. - Blast phase is defined by either of the following: - Blasts 20% or more of peripheral blood white cells or bone marrow cells - Extramedullary blast proliferation - Large foci or clusters of blasts in bone marrow biopsy - Primary myelodysplastic syndrome (MDS) with an IPSS score >1 - Secondary MDS with any international prostate symptom score (IPSS) - Age ≤60 years - Co-Morbidity score 0-2 - At least 35 days following start of preceding leukemia induction therapy Exclusion Criteria: - Patients for whom a suitable HLA genotypically identical sibling or fully matched HLA-A, -B, -C, and -DRB1 unrelated donor is available. - Patients greater than 60 years of age. - Hypersensitivity to thymoglobulin. - Symptomatic uncontrolled coronary artery disease or congestive heart failure. - Hepatic disease with transaminases or bilirubin > 2 times upper limit of normal (ULN) except for isolated hyperbilirubinemia attributed to Gilbert's syndrome. - Severe hypoxemia with room air - Partial Pressure of Oxygen in Arterial Blood - (PAO2) < 70, supplemental oxygen-dependence, or carbon monoxide diffusing capacity (DLCO) < 50% predicted. - Impaired renal function with creatinine > 2 times upper limit of normal (ULN) or creatinine clearance measured by 24-hour urine collection < 50% normal for age, gender, and weight. - Patients with central nervous system (CNS) involvement with disease refractory to intrathecal chemotherapy. - Patients who are human immunodeficiency virus (HIV) seropositive. - Patients who are pregnant or breast-feeding. - Patients with active infections that are untreated, or failing to respond to appropriate therapy. - Karnofsky performance status < 50%. - Prior allogeneic or autologous bone marrow, peripheral blood stem cell, or umbilical cord blood transplant. - Inability to provide informed consent. - Co-morbidity score >2 - Less than 35 days from start of previous leukemia induction therapy |