Clinical trial NCT00039910: Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Hodgkin Lymphoma
Hodgkin Disease
Thrombocytopenia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2002-06-17
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: 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:
measure: Identify the effect of rhTPO on the number of platelet transfusions
measure: Evaluate the severity and duration of thrombocytopenia and neutropenia associated with rhTPO prophylaxis
measure: Quantify the effect of rhTPO on the occurrence of any bleeding events associated with thrombocytopenia
measure: Assess the likelihood that patients were to have adequate hematologic recovery to allow on-time chemotherapy administration in the subsequent cycles
measure: Assess the safety of multiple IV doses of rhTPO
measure: Determine the occurrence and clinical implications of any anti-TPO antibodies
measure: Assess the antitumor activity of DHAP chemotherapy
measure: Evaluate the impact of rhTPO prophylaxis on health economics/cost effectiveness
measure: Evaluate the impact of rhTPO prophylaxis on patient quality of life
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: La Jolla
country: United States
facility: Pfizer Investigational Site
state: California
city: Loma Linda
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Orange
country: United States
facility: Pfizer Investigational Site
state: California
city: Tamarac
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Lake Charles
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Detroit
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Southfield
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: St. Joseph
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Jefferson City
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Jefferson City
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Brooklyn
country: United States
facility: Pfizer Investigational Site
state: New York
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Coos Bay
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Hershey
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Bristol
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Abingdon
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Abingdon
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Lebanon
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Marion
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: East Melbourne
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Paris
country: France
facility: Pfizer Investigational Site
city: Tours
country: France
facility: Pfizer Investigational Site
city: Thessaloniki
country: Greece
facility: Pfizer Investigational Site
state: Macedonia
city: Shatin
country: Hong Kong
facility: Pfizer Investigational Site
state: New Territories
city: Lodz
country: Poland
facility: Pfizer Investigational Site
city: Warsaw
country: Poland
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: