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The primary objective of this study is to assess the safety and effectiveness of ABT-510 in subjects with refractory lymphoma.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-510 - Thrombospondin-1 Mimetic | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | One year | |
| Overall survival | One year | |
| Performance status |
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Inclusion Criteria:
A subject will be eligible for study participation if all of the following criteria are met:
The subject is at least 18 years of age.
The subject has histologically confirmed non-Hodgkin's Lymphoma (NHL) (excluding Burkitt's, Burkitt's type or HIV associated lymphoma) or Hodgkin's Lymphoma (HL) that is refractory to or has relapsed after standard therapy or for which there is no known effective treatment.
The subject must have measurable disease by the CHESON Criteria for Tumor Response.
The subject has an Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.
The subject is able to self-administer or has a caregiver who can reliably administer subcutaneous injections.
The subject must have adequate bone marrow, renal and hepatic function as follows:
The subject must not be pregnant or lactating and all subjects (male and female) must use a contraceptive method deemed appropriate by the investigator while in the study and up to two months following completion of therapy.
The subject has voluntarily signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved consent prior to any study specific procedures.
Exclusion Criteria:
A subject will be ineligible for study participation if any of the following criteria are met:
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| Name | Affiliation | Role |
|---|---|---|
| Rod Humerickhouse, MD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hematology Oncology Associates | Phoenix | Arizona | 85012 | United States | ||
| Arizona Clinical Research Center |
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| One year |
| Tucson |
| Arizona |
| 85712 |
| United States |
| USC - Norris Cancer Center | Los Angeles | California | 90033 | United States |
| The Center for Hematology-Oncology | Boca Raton | Florida | 33486 | United States |
| Oncology-Hematology Group of South Florida | Miami | Florida | 33176 | United States |
| Cancer Centers of Florida, P.A. | Orlando | Florida | 32806 | United States |
| Kansas City Oncology and Hematology Group | Kansas City | Missouri | 64111 | United States |
| Arch Medical Services, INC. | St Louis | Missouri | 63142 | United States |
| Albany Regional Cancer Center | Albany | New York | 12208 | United States |
| Raleigh Hematology Oncology Clinic | Cary | North Carolina | 27511 | United States |
| The West Cancer Clinic | Memphis | Tennessee | 38120 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Hematology Oncology Associates | San Antonio | Texas | 78229 | United States |
| U of W - Comprehensive Care Center | Madison | Wisconsin | 53792 | United States |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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