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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00039910




Registration number
NCT00039910
Ethics application status
Date submitted
14/06/2002
Date registered
17/06/2002
Date last updated
4/05/2007

Titles & IDs
Public title
Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia
Scientific 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
Secondary ID [1] 0 0
444-ONC-0003-0019
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Hodgkin Lymphoma 0 0
Hodgkin Disease 0 0
Thrombocytopenia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Hodgkin's
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - (PN-152,243)/ PN-196,444

Treatment: Drugs: (PN-152,243)/ PN-196,444
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Identify the effect of rhTPO on the number of platelet transfusions
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Evaluate the severity and duration of thrombocytopenia and neutropenia associated with rhTPO prophylaxis
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Quantify the effect of rhTPO on the occurrence of any bleeding events associated with thrombocytopenia
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Assess the likelihood that patients were to have adequate hematologic recovery to allow on-time chemotherapy administration in the subsequent cycles
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Assess the safety of multiple IV doses of rhTPO
Timepoint [5] 0 0
Secondary outcome [6] 0 0
Determine the occurrence and clinical implications of any anti-TPO antibodies
Timepoint [6] 0 0
Secondary outcome [7] 0 0
Assess the antitumor activity of DHAP chemotherapy
Timepoint [7] 0 0
Secondary outcome [8] 0 0
Evaluate the impact of rhTPO prophylaxis on health economics/cost effectiveness
Timepoint [8] 0 0
Secondary outcome [9] 0 0
Evaluate the impact of rhTPO prophylaxis on patient quality of life
Timepoint [9] 0 0

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients must not have active bleeding (exclusions do apply) or history of platelet
disorder

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2000
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2003
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - East Melbourne
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
Nebraska
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Oregon
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Tennessee
Country [14] 0 0
United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
France
State/province [15] 0 0
Paris
Country [16] 0 0
France
State/province [16] 0 0
Tours
Country [17] 0 0
Greece
State/province [17] 0 0
Macedonia
Country [18] 0 0
Hong Kong
State/province [18] 0 0
New Territories
Country [19] 0 0
Poland
State/province [19] 0 0
Lodz
Country [20] 0 0
Poland
State/province [20] 0 0
Warsaw
Country [21] 0 0
Russian Federation
State/province [21] 0 0
Moscow
Country [22] 0 0
Singapore
State/province [22] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00039910
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00039910