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Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00039910
Recruitment Status : Completed
First Posted : June 17, 2002
Last Update Posted : May 4, 2007
Sponsor:
Information provided by:
Pfizer

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

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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 :
  1. 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 :
  1. Identify the effect of rhTPO on the number of platelet transfusions
  2. Evaluate the severity and duration of thrombocytopenia and neutropenia associated with rhTPO prophylaxis
  3. Quantify the effect of rhTPO on the occurrence of any bleeding events associated with thrombocytopenia
  4. Assess the likelihood that patients were to have adequate hematologic recovery to allow on-time chemotherapy administration in the subsequent cycles
  5. Assess the safety of multiple IV doses of rhTPO
  6. Determine the occurrence and clinical implications of any anti-TPO antibodies
  7. Assess the antitumor activity of DHAP chemotherapy
  8. Evaluate the impact of rhTPO prophylaxis on health economics/cost effectiveness
  9. Evaluate the impact of rhTPO prophylaxis on patient quality of life


Information from the National Library of Medicine

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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
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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
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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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:
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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