Clinical trial · Interventional
Trial of Primary Prophylaxis With rhTPO Administered to Patients With High Risk Sarcoma Receiving Intensive Chemotherapy
Randomized Double-blind Placebo-controlled Trial of Primary Prophylaxis With Recombinant Human Thrombopoietin Administered to Patients With High Risk Sarcoma Receiving Intensive Chemotherapy
NCT00283582CI-TRIAL-00035515completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Intensive chemotherapy is often associated with low platelet counts often requiring platelet transfusions to maintain platelet counts. In previous clinical studies administration of rhTPO has been demonstrated to increase platelet counts.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| rhTPO | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- CBC with diff. at least three times a week and daily if platelet less than 50,000. Chemistry, coagulation, urinalysis performed at baseline and at end of cycle if necessary.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 13 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed new diagnosis of moderate or high-grade sarcoma (except leiomyosarcoma of gastrointestinal origin) * Must have high risk disease by American Joint Committee on Cancer (AJCC) Staging System Stage IIC, III, or IV * Must have recovered from surgery for a minimum of 2 weeks * Must be scheduled for a minimum of 4 cycles of AI therapy * Must be 13 years or older * Must have ECOG performance status of 0, 1, or 2. * Must have life expectancy of at least 12 weeks. * Left ventricular ejection fraction must be more than 50%. * Laboratory data within normal limits. Exclusion Criteria: * Prior front-line standard or experimental therapy for sarcoma * History of bone marrow and or peripheral blood progenitor cell transplantation * Prior pelvic radiation or radiation therapy to more than 25% of bone marrow reserves * Prior treatment with megakaryocyte growth and differentiation factor * Prior treatment with rhTPO * History of platelet disorder * History of myocardial infarction, stroke, pulmonary embolism, or deep vein thrombosis within the past 12 months * Pregnant or lactating women * Use of anticoagulants such as coumadin, heparin, etc. * Known HIV or hepatitis
References
Publications (0)
Data not yet available
No reference posted for this study.