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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00039910

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 III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Hodgkin Disease Lymphoma

U.S. FDA Resources

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:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

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

Study placed in the following topic categories:

Dexamethasone
Immunoproliferative Disorders
Hematologic Diseases
Hodgkin Lymphoma, Adult
Blood Platelet Disorders
Hodgkin's Disease
Recurrence
Lymphoma, Small Cleaved-cell, Diffuse
Thrombocytopathy

Lymphatic Diseases
Thrombocytopenia
Cisplatin
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Hodgkin Disease
Dexamethasone acetate
Cytarabine

Additional relevant MeSH terms:

Lymphatic Diseases
Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type
Thrombocytopenia
Immune System Diseases

Hematologic Diseases
Blood Platelet Disorders
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Hodgkin Disease

ClinicalTrials.gov processed this record on September 11, 2009