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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00039910 |
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.
Condition | Intervention | Phase |
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Non-Hodgkin Lymphoma Hodgkin Disease Thrombocytopenia |
Drug: (PN-152,243)/
PN-196,444 |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia in Recurrent or Refractory Non-Burkitt's, Non-Hodgkin's Lymphoma (NHL) or Hodgkin's Disease Receiving DHAP (Dexamethasone, High-Dose Cytarabine and Cisplatin) Chemotherapy |
Estimated Enrollment: | 240 |
Study Start Date: | July 2000 |
Study Completion Date: | March 2003 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Study ID Numbers: | 444-ONC-0003-0019 |
Study First Received: | June 14, 2002 |
Last Updated: | May 3, 2007 |
ClinicalTrials.gov Identifier: | NCT00039910 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Dexamethasone Immunoproliferative Disorders Hematologic Diseases Hodgkin Lymphoma, Adult Blood Platelet Disorders Hodgkin's Disease Recurrence Lymphoma, Small Cleaved-cell, Diffuse Thrombocytopathy |
Lymphatic Diseases Thrombocytopenia Cisplatin Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Hodgkin Disease Dexamethasone acetate Cytarabine |
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type Thrombocytopenia Immune System Diseases |
Hematologic Diseases Blood Platelet Disorders Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma Hodgkin Disease |