Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia
NCT00039910
Last updated date
ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-Hodgkin Lymphoma, Hodgkin Disease, Thrombocytopenia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Patients must not have active bleeding (exclusions do apply) or history of platelet
disorder
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Non-Hodgkin Lymphoma, Hodgkin Disease, ThrombocytopeniaSafety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia
NCT00039910
- Phoenix, Arizona
- La Jolla, California
- Loma Linda, California
- Los Angeles, California
- Los Angeles, California
- Los Angeles, California
- Los Angeles, California
- Orange, California
- Tamarac, Florida
- Chicago, Illinois
- Chicago, Illinois
- Lake Charles, Louisiana
- Detroit, Michigan
- Southfield, Michigan
- St. Joseph, Michigan
- Jefferson City, Missouri
- Jefferson City, Missouri
- Omaha, Nebraska
- Brooklyn, New York
- Durham, North Carolina
- Coos Bay, Oregon
- Hershey, Pennsylvania
- Bristol, Tennessee
- Abingdon, Virginia
- Abingdon, Virginia
- Lebanon, Virginia
- Marion, Virginia
- East Melbourne, Victoria
- Paris,
- Tours,
- Thessaloniki, Macedonia
- Shatin, New Territories
- Lodz,
- Warsaw,
- Moscow,
- Moscow,
- Singapore,
- Singapore,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia | |||
| Official Title ICMJE | 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 | |||
| 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 3 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Prevention | |||
| Condition ICMJE |
| |||
| Intervention ICMJE | Drug: (PN-152,243)/ PN-196,444 | |||
| Study Arms ICMJE | Not Provided | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Enrollment ICMJE | 240 | |||
| Original Enrollment ICMJE | Not Provided | |||
| Actual Study Completion Date ICMJE | March 2003 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Australia, France, Greece, Hong Kong, Poland, Russian Federation, Singapore, United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00039910 | |||
| Other Study ID Numbers ICMJE | 444-ONC-0003-0019 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Not Provided | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | September 2006 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||