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	Treatment or Intervention	Phase
Non-Hodgkin Lymphoma Hodgkin Disease Thrombocytopenia		Phase III

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Other specific inclusion/exclusion criteria may apply. In order to determine eligibility, further examination by the investigator is necessary.

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

Arizona
      Research Center, Scottsdale,  Arizona,  85260,  United States
California
      Research Center, Loma Linda,  California,  92354,  United States
      Research Center, Los Angeles,  California,  90048,  United States
      Research Center, La Jolla,  California,  92037,  United States
      Research Center, Orange,  California,  92868,  United States
      Research Center, Los Angeles,  California,  90033-0804,  United States
Florida
      Research Center, Pensacola,  Florida,  32514,  United States
      Research Center, Hollywood,  Florida,  33021,  United States
      Research Center, Tamarac,  Florida,  33321,  United States
Illinois
      Research Center, Maywood,  Illinois,  60153,  United States
      Research Center, Chicago,  Illinois,  60637,  United States
Louisiana
      Research Center, Lake Charles,  Louisiana,  70601,  United States
Maryland
      Research Center, Frederick,  Maryland,  21702,  United States
Michigan
      Research Center, Detroit,  Michigan,  48202,  United States
      Research Center, St. Joseph,  Michigan,  49085,  United States
      Research Center, Southfield,  Michigan,  48076,  United States
Missouri
      Research Center, Jefferson City,  Missouri,  65109,  United States
Nebraska
      Research Center, Omaha,  Nebraska,  68198,  United States
New York
      Research Center, Brooklyn,  New York,  11235,  United States
North Carolina
      Research Center, Durham,  North Carolina,  27705,  United States
Oklahoma
      Research Center, Oklahoma City,  Oklahoma,  73104,  United States
Oregon
      Research Center, Coos Bay,  Oregon,  97420,  United States
Pennsylvania
      Research Center, Hershey,  Pennsylvania,  17033,  United States
Texas
      Research Center, Lubbock,  Texas,  79410,  United States
Virginia
      Research Center, Abingdon,  Virginia,  24211,  United States

Study ID Numbers:  444-ONC-0003-0019
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  June 14, 2002
ClinicalTrials.gov Identifier:  NCT00039910
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08