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

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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

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

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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


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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


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Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
ClinicalTrials.gov Identifier: NCT00039910     History of Changes
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
Thrombocytopenia
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Blood Platelet Disorders
Hematologic Diseases