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After review of safety events and have decided that further dose escalation of MEDI-507 as a single agent is not feasible.
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For primary objectives, we will determine the MTD and examine clinical responses and immune cell populations to determine an OBD, and describe the safety and tolerability of MEDI-507.
For the secondary objectives we will look at the antitumor activity of MEDI 507, PK, serum concentrations, and immunogenicity of MEDI-507, as well as time courses of depletion and recovery of CD2 positive and total T-Cell populations.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI-507 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the maximum tolerated dose (MTD) or the optimal biological dose | ||
| (OBD) of MEDI-507 based on safety and tolerability of MEDI-507 in patients with | ||
| CD-2 positive lymphoproliferative disorders. |
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Individuals may be eligible for this study if they are 18 years of age or older and:
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| Name | Affiliation | Role |
|---|---|---|
| Luz Hammershaimb, MD | MedImmune LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC/Norris Cancer Center | Los Angeles | California | 90033 | United States | ||
| Yale Cancer Center |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D007938 | Leukemia |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C544394 | siplizumab |
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| New Haven |
| Connecticut |
| 06520 |
| United States |
| Georgetown University Medical Center, Lombardi Comprehensive Cancer Center | Washington D.C. | District of Columbia | 20007 | United States |
| H. Lee Moffitt Cancer Ctr & Research Institute Div of Hem/Onc | Tampa | Florida | 33612 | United States |
| University of Maryland School of Medicine, Greenebaum Cancer Center | Baltimore | Maryland | 21201 | United States |
| Tufts New England Medical Center | Boston | Massachusetts | 02111 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Nevada Cancer Institute | Las Vegas | Nevada | 89135 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27517 | United States |
| Kimmel Cancer Center, Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| M.D. Anderson Cancer Center | Houston | Texas | 77030 | United States |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006402 | Hematologic Diseases |