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Completed

NCT Number: NCT00039910

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

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.

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Key information

Conditions

Non-Hodgkin Lymphoma Blood Platelet Disorders Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Thrombocytopenia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, East Melbourne, Victoria, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

(PN-152,243)/ PN-196,444

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2000
Study completion
2003
First posted
Jun 17, 2002
Registry last updated
May 4, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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