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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Non-Hodgkin Lymphoma, Hodgkin Disease, Thrombocytopenia

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Outcome 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.

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

444-ONC-0003-0019

NCT ID:

NCT00039910

Start Date:

July 2000

Completion Date:

March 2003

Related Keywords:

  • Non-Hodgkin Lymphoma
  • Hodgkin Disease
  • Thrombocytopenia
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Thrombocytopenia

Name

Location
Pfizer Investigational Site Blendora, California  91740
Pfizer Investigational Site Detroit, Michigan  48201
Pfizer Investigational Site Springfield, Illinois  62701-1014
Pfizer Investigational Site Bronx, New York  10461
Pfizer Investigational Site Richmond, Virginia  23249
Pfizer Investigational Site Flagstaff, Arizona  86001
Pfizer Investigational Site Clearwater, Florida  33761
Pfizer Investigational Site Columbia, Missouri  65201
Pfizer Investigational Site Asheville, North Carolina  28801
Pfizer Investigational Site Eugene, Oregon  97401
Pfizer Investigational Site Kingston, Pennsylvania  18704-5535
Pfizer Investigational Site Shreveport, Louisiana  71103
Pfizer Investigational Site Omaha, Nebraska  68198
Pfizer Investigational Site Bristol, Tennessee  37620