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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00039910
First received: June 14, 2002
Last updated: May 3, 2007
Last verified: September 2006
  Purpose

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
Non-Hodgkin Lymphoma
Hodgkin Disease
Thrombocytopenia
Drug: (PN-152,243)/ PN-196,444
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

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

Estimated Enrollment: 240
Study Start Date: July 2000
Study Completion Date: March 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00039910

  Show 38 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00039910     History of Changes
Other Study ID Numbers: 444-ONC-0003-0019
Study First Received: June 14, 2002
Last Updated: May 3, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Lymphoma, Non-Hodgkin
Thrombocytopenia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Blood Platelet Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014