Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia
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| ClinicalTrials.gov Identifier: NCT00039910 |
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Recruitment Status :
Completed
First Posted : June 17, 2002
Last Update Posted : May 4, 2007
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Sponsor:
Pfizer
Information provided by:
Pfizer
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Non-Hodgkin Lymphoma Hodgkin Disease Thrombocytopenia | Drug: (PN-152,243)/ PN-196,444 | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 240 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| Primary Purpose: | Prevention |
| 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 |
| Study Start Date : | July 2000 |
| Actual Study Completion Date : | March 2003 |
Resource links provided by the National Library of Medicine
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- Identify the effect of rhTPO on the number of platelet transfusions
- Evaluate the severity and duration of thrombocytopenia and neutropenia associated with rhTPO prophylaxis
- 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients must have recurrent or refractory intermediate-grade or high-grade non-Burkitt's, non-Hodgkin's lymphoma (NHL) or Hodgkin's disease and be scheduled for a minimum of 2 cycles of DHAP (Dexamethasone, high-dose Cytarabine and Cisplatin) chemotherapy
Exclusion Criteria:
- Patients must not have active bleeding (exclusions do apply) or history of platelet disorder
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00039910
Locations
| United States, Arizona | |
| Pfizer Investigational Site | |
| Phoenix, Arizona, United States, 85023 | |
| United States, California | |
| Pfizer Investigational Site | |
| La Jolla, California, United States, 92037 | |
| Pfizer Investigational Site | |
| Loma Linda, California, United States, 92354 | |
| Pfizer Investigational Site | |
| Los Angeles, California, United States, 90033-0804 | |
| Pfizer Investigational Site | |
| Los Angeles, California, United States, 90036 | |
| Pfizer Investigational Site | |
| Los Angeles, California, United States, 90048 | |
| Pfizer Investigational Site | |
| Los Angeles, California, United States, 90089 | |
| Pfizer Investigational Site | |
| Orange, California, United States, 92868 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Tamarac, Florida, United States, 33321 | |
| United States, Illinois | |
| Pfizer Investigational Site | |
| Chicago, Illinois, United States, 60637 | |
| Pfizer Investigational Site | |
| Chicago, Illinois, United States, 60640 | |
| United States, Louisiana | |
| Pfizer Investigational Site | |
| Lake Charles, Louisiana, United States, 70601 | |
| United States, Michigan | |
| Pfizer Investigational Site | |
| Detroit, Michigan, United States, 48202 | |
| Pfizer Investigational Site | |
| Southfield, Michigan, United States, 48076 | |
| Pfizer Investigational Site | |
| St. Joseph, Michigan, United States, 49085 | |
| United States, Missouri | |
| Pfizer Investigational Site | |
| Jefferson City, Missouri, United States, 65109 | |
| Pfizer Investigational Site | |
| Jefferson City, Missouri, United States, 90048 | |
| United States, Nebraska | |
| Pfizer Investigational Site | |
| Omaha, Nebraska, United States, 68198 | |
| United States, New York | |
| Pfizer Investigational Site | |
| Brooklyn, New York, United States, 11235 | |
| United States, North Carolina | |
| Pfizer Investigational Site | |
| Durham, North Carolina, United States, 27705 | |
| United States, Oregon | |
| Pfizer Investigational Site | |
| Coos Bay, Oregon, United States, 97420 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | |
| Hershey, Pennsylvania, United States, 17033 | |
| United States, Tennessee | |
| Pfizer Investigational Site | |
| Bristol, Tennessee, United States, 37620 | |
| United States, Virginia | |
| Pfizer Investigational Site | |
| Abingdon, Virginia, United States, 24210 | |
| Pfizer Investigational Site | |
| Abingdon, Virginia, United States, 24211 | |
| Pfizer Investigational Site | |
| Lebanon, Virginia, United States, 24266 | |
| Pfizer Investigational Site | |
| Marion, Virginia, United States, 24354 | |
| Australia, Victoria | |
| Pfizer Investigational Site | |
| East Melbourne, Victoria, Australia, 3002 | |
| France | |
| Pfizer Investigational Site | |
| Paris, France | |
| Pfizer Investigational Site | |
| Tours, France, 37044 | |
| Greece | |
| Pfizer Investigational Site | |
| Thessaloniki, Macedonia, Greece, 540 07 | |
| Hong Kong | |
| Pfizer Investigational Site | |
| Shatin, New Territories, Hong Kong | |
| Poland | |
| Pfizer Investigational Site | |
| Lodz, Poland, 93-510 | |
| Pfizer Investigational Site | |
| Warsaw, Poland | |
| Russian Federation | |
| Pfizer Investigational Site | |
| Moscow, Russian Federation, 115478 | |
| Pfizer Investigational Site | |
| Moscow, Russian Federation, 125167 | |
| Singapore | |
| Pfizer Investigational Site | |
| Singapore, Singapore, 169608 | |
| Pfizer Investigational Site | |
| Singapore, Singapore, 169610 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
| ClinicalTrials.gov Identifier: | NCT00039910 |
| Other Study ID Numbers: |
444-ONC-0003-0019 |
| First Posted: | June 17, 2002 Key Record Dates |
| Last Update Posted: | May 4, 2007 |
| Last Verified: | September 2006 |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Hodgkin Disease Thrombocytopenia Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Blood Platelet Disorders Hematologic Diseases |