Study of Romiplostim for Chemotherapy Induced Thrombocytopenia (NCT02052882) | Clinical Trial Compass
CompletedPhase 2
Study of Romiplostim for Chemotherapy Induced Thrombocytopenia
United States60 participantsStarted 2014-01-30
Plain-language summary
This study is to determine if using weekly romiplostim injections will improve the patient's platelet count more effectively than simply waiting for the platelets to improve on its own, and if romiplostim will also allow the patient to receive at least 2 further cycles of chemotherapy without thrombocytopenia.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Nucleoside Analogue, including gemcitabine and fluorouracil
✓. Carboplatin or cisplatin
✓. Anthracycline
✓. Alkylating agent
✓. Other chemotherapy agents with thrombocytopenia as known common toxicity.
✓.KPS ≥ 50 or ECOG performance status ≤2 .
✓.Ability to provide written informed consent.
Exclusion criteria
✕. Patients with history of hematologic malignancies, including leukemia, myeloma, myeloproliferative disease, lymphoma, or myelodysplastic diseases.
✕. Patients with known bone metastases, with evidence of corticol bone damage/lytic lesions/blastic lesions on standard imaging studies (CT/MR)
✕. Anemia (Hgb \<8.0 gm/dl) or leukopenia (absolute neutrophil count (ANC) \<1,000/mcL). Use of red cell transfusions, erythropoietin, or G-CSF, as ordered by the managing oncology service, is acceptable and does not preclude participation.
✕. Patients with underlying liver disease, such as cirrhosis or chronic hepatitis, and do not have primary or metastatic cancer in the liver will be excluded if ALT/AST \>3X ULN or Total Bili \>3X ULN. In the presence of primary or metastatic liver cancer, patients will be excluded if ALT/AST \>5X ULN or Total Bili \>5X ULN
✕
What they're measuring
1
Percentage of Participants Who Achieved Platelet Counts of ≥ 100,000/mcL
. Patients with a history of a prior symptomatic venous thrombotic event such, as DVT or pulmonary embolism and symptomatic arterial thrombotic events such as myocardial infarction, ischemic cerebral vascular accident or transient ischemic attack will be ineligible if they have not tolerated anticoagulation therapy. If patients remain on anticoagulation, or have completed the prescribed course of anticoagulation, they will be eligible for enrollment. A venous thrombotic event associated with a central venous catheter will not make the patient ineligible.
✕. Serious concomitant medical condition that could interfere with the conduct of the clinical trial, such as unstable angina, renal failure requiring hemodialysis, or active infection requiring IV antibiotics