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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00039910

Collaborator

(none)

240

Enrollment

Locations

Duration (Months)

6.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-Hodgkin Lymphoma Hodgkin Disease Thrombocytopenia	Drug: (PN-152,243)/ PN-196,444	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Prevention

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 Start Date :

Jul 1, 2000

Actual Study Completion Date :

Mar 1, 2003

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Phoenix	Arizona	United States	85023
2	Pfizer Investigational Site	La Jolla	California	United States	92037
3	Pfizer Investigational Site	Loma Linda	California	United States	92354
4	Pfizer Investigational Site	Los Angeles	California	United States	90033-0804
5	Pfizer Investigational Site	Los Angeles	California	United States	90036
6	Pfizer Investigational Site	Los Angeles	California	United States	90048
7	Pfizer Investigational Site	Los Angeles	California	United States	90089
8	Pfizer Investigational Site	Orange	California	United States	92868
9	Pfizer Investigational Site	Tamarac	Florida	United States	33321
10	Pfizer Investigational Site	Chicago	Illinois	United States	60637
11	Pfizer Investigational Site	Chicago	Illinois	United States	60640
12	Pfizer Investigational Site	Lake Charles	Louisiana	United States	70601
13	Pfizer Investigational Site	Detroit	Michigan	United States	48202
14	Pfizer Investigational Site	Southfield	Michigan	United States	48076
15	Pfizer Investigational Site	St. Joseph	Michigan	United States	49085
16	Pfizer Investigational Site	Jefferson City	Missouri	United States	65109
17	Pfizer Investigational Site	Jefferson City	Missouri	United States	90048
18	Pfizer Investigational Site	Omaha	Nebraska	United States	68198
19	Pfizer Investigational Site	Brooklyn	New York	United States	11235
20	Pfizer Investigational Site	Durham	North Carolina	United States	27705
21	Pfizer Investigational Site	Coos Bay	Oregon	United States	97420
22	Pfizer Investigational Site	Hershey	Pennsylvania	United States	17033
23	Pfizer Investigational Site	Bristol	Tennessee	United States	37620
24	Pfizer Investigational Site	Abingdon	Virginia	United States	24210
25	Pfizer Investigational Site	Abingdon	Virginia	United States	24211
26	Pfizer Investigational Site	Lebanon	Virginia	United States	24266
27	Pfizer Investigational Site	Marion	Virginia	United States	24354
28	Pfizer Investigational Site	East Melbourne	Victoria	Australia	3002
29	Pfizer Investigational Site	Paris		France
30	Pfizer Investigational Site	Tours		France	37044
31	Pfizer Investigational Site	Thessaloniki	Macedonia	Greece	540 07
32	Pfizer Investigational Site	Shatin	New Territories	Hong Kong
33	Pfizer Investigational Site	Lodz		Poland	93-510
34	Pfizer Investigational Site	Warsaw		Poland
35	Pfizer Investigational Site	Moscow		Russian Federation	115478
36	Pfizer Investigational Site	Moscow		Russian Federation	125167
37	Pfizer Investigational Site	Singapore		Singapore	169608
38	Pfizer Investigational Site	Singapore		Singapore	169610