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Intensive chemotherapy is associated with significant thrombocytopenia, often requiring platelet transfusion to maintain platelet counts. This investigational drug has been demonstrated to increase platelet counts. This study will test the safety and efficacy of the investigational drug in the prevention of thrombocytopenia in patients with recurrent or refractory intermediate-grade or high-grade non-Burkitt's, non-Hodgkin's lymphoma (NHL), or Hodgkin's disease receiving DHAP (Dexamethasone, high-dose Cytarabine, and Cisplatin) chemotherapy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| (PN-152,243)/ PN-196,444 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effectiveness of primary prophylaxis with intravenous rhTPO versus placebo in reducing the cumulative proportion of patients who experience severe chemotherapy-induced thrombocytopenia. |
| Measure | Description | Time Frame |
|---|---|---|
| Identify the effect of rhTPO on the number of platelet transfusions | ||
| Evaluate the severity and duration of thrombocytopenia and neutropenia associated with rhTPO prophylaxis | ||
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Phoenix | Arizona | 85023 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Quantify the effect of rhTPO on the occurrence of any bleeding events associated with thrombocytopenia |
| Assess the likelihood that patients were to have adequate hematologic recovery to allow on-time chemotherapy administration in the subsequent cycles |
| Assess the safety of multiple IV doses of rhTPO |
| Determine the occurrence and clinical implications of any anti-TPO antibodies |
| Assess the antitumor activity of DHAP chemotherapy |
| Evaluate the impact of rhTPO prophylaxis on health economics/cost effectiveness |
| Evaluate the impact of rhTPO prophylaxis on patient quality of life |
| La Jolla |
| California |
| 92037 |
| United States |
| Pfizer Investigational Site | Loma Linda | California | 92354 | United States |
| Pfizer Investigational Site | Los Angeles | California | 90033-0804 | United States |
| Pfizer Investigational Site | Los Angeles | California | 90036 | United States |
| Pfizer Investigational Site | Los Angeles | California | 90048 | United States |
| Pfizer Investigational Site | Los Angeles | California | 90089 | United States |
| Pfizer Investigational Site | Orange | California | 92868 | United States |
| Pfizer Investigational Site | Tamarac | Florida | 33321 | United States |
| Pfizer Investigational Site | Chicago | Illinois | 60637 | United States |
| Pfizer Investigational Site | Chicago | Illinois | 60640 | United States |
| Pfizer Investigational Site | Lake Charles | Louisiana | 70601 | United States |
| Pfizer Investigational Site | Detroit | Michigan | 48202 | United States |
| Pfizer Investigational Site | Saint Joseph | Michigan | 49085 | United States |
| Pfizer Investigational Site | Southfield | Michigan | 48076 | United States |
| Pfizer Investigational Site | Jefferson City | Missouri | 65109 | United States |
| Pfizer Investigational Site | Jefferson City | Missouri | 90048 | United States |
| Pfizer Investigational Site | Omaha | Nebraska | 68198 | United States |
| Pfizer Investigational Site | Brooklyn | New York | 11235 | United States |
| Pfizer Investigational Site | Durham | North Carolina | 27705 | United States |
| Pfizer Investigational Site | Coos Bay | Oregon | 97420 | United States |
| Pfizer Investigational Site | Hershey | Pennsylvania | 17033 | United States |
| Pfizer Investigational Site | Bristol | Tennessee | 37620 | United States |
| Pfizer Investigational Site | Abingdon | Virginia | 24210 | United States |
| Pfizer Investigational Site | Abingdon | Virginia | 24211 | United States |
| Pfizer Investigational Site | Lebanon | Virginia | 24266 | United States |
| Pfizer Investigational Site | Marion | Virginia | 24354 | United States |
| Pfizer Investigational Site | East Melbourne | Victoria | 3002 | Australia |
| Pfizer Investigational Site | Paris | France |
| Pfizer Investigational Site | Tours | 37044 | France |
| Pfizer Investigational Site | Thessaloniki | Macedonia | 540 07 | Greece |
| Pfizer Investigational Site | Shatin | New Territories | Hong Kong |
| Pfizer Investigational Site | Lodz | 93-510 | Poland |
| Pfizer Investigational Site | Warsaw | Poland |
| Pfizer Investigational Site | Moscow | 115478 | Russia |
| Pfizer Investigational Site | Moscow | 125167 | Russia |
| Pfizer Investigational Site | Singapore | 169608 | Singapore |
| Pfizer Investigational Site | Singapore | 169610 | Singapore |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D006689 | Hodgkin Disease |
| D013921 | Thrombocytopenia |
| 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 |
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D000095542 | Cytopenia |
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