Hodgkin Disease, Non-Hodgkin Lymphoma, Thrombocytopenia
Conditions
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.
Interventions
DRUG(PN-152,243)/ PN-196,444
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
| Identify the effect of rhTPO on the number of platelet transfusions | — |
| 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 | — |
| Determine the occurrence and clinical implications of any anti-TPO antibodies | — |
Countries
Australia, France, Greece, Hong Kong, Poland, Russia, Singapore, United States
Outcome results
None listed