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

NCT00039910

Last updated date
Study Location
Pfizer Investigational Site
Phoenix, Arizona, 85023, United States
Contact
1-800-718-1021

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Pfizer Clinical Trials Contact Center

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-Hodgkin Lymphoma, Hodgkin Disease, Thrombocytopenia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Patients must not have active bleeding (exclusions do apply) or history of platelet
disorder

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Non-Hodgkin Lymphoma, Hodgkin Disease, ThrombocytopeniaSafety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia
NCT00039910
  1. Phoenix, Arizona
  2. La Jolla, California
  3. Loma Linda, California
  4. Los Angeles, California
  5. Los Angeles, California
  6. Los Angeles, California
  7. Los Angeles, California
  8. Orange, California
  9. Tamarac, Florida
  10. Chicago, Illinois
  11. Chicago, Illinois
  12. Lake Charles, Louisiana
  13. Detroit, Michigan
  14. Southfield, Michigan
  15. St. Joseph, Michigan
  16. Jefferson City, Missouri
  17. Jefferson City, Missouri
  18. Omaha, Nebraska
  19. Brooklyn, New York
  20. Durham, North Carolina
  21. Coos Bay, Oregon
  22. Hershey, Pennsylvania
  23. Bristol, Tennessee
  24. Abingdon, Virginia
  25. Abingdon, Virginia
  26. Lebanon, Virginia
  27. Marion, Virginia
  28. East Melbourne, Victoria
  29. Paris,
  30. Tours,
  31. Thessaloniki, Macedonia
  32. Shatin, New Territories
  33. Lodz,
  34. Warsaw,
  35. Moscow,
  36. Moscow,
  37. Singapore,
  38. Singapore,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE
  • Non-Hodgkin Lymphoma
  • Hodgkin Disease
  • Thrombocytopenia
Intervention  ICMJE Drug: (PN-152,243)/ PN-196,444
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 28, 2006)
240
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   France,   Greece,   Hong Kong,   Poland,   Russian Federation,   Singapore,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00039910
Other Study ID Numbers  ICMJE 444-ONC-0003-0019
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP