Secondary Prophylaxis in Non-Hodgkin Lymphoma (NHL) and Chemotherapy-induced Thrombocytopenia (NCT01516619) | Clinical Trial Compass
CompletedPhase 2
Secondary Prophylaxis in Non-Hodgkin Lymphoma (NHL) and Chemotherapy-induced Thrombocytopenia
Italy3 participantsStarted 2011-11
Plain-language summary
This is a monocentric, prospective phase II trial addressing safety and capability to prevent grade-4 Chemotherapy-induced Thrombocytopenia (CIT) of romiplostim in patients with NHL.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient with NHL of any histotype, both at diagnosis or at relapse, who experienced grade 4 CIT after the first course of chemotherapy containing high doses of methotrexate, cytarabine, cisplatin, cyclophosphamide and/or ifosfamide, and/or conventional doses of anthracyclines or purine analogs, with or without rituximab. The same type of chemotherapy where the grade 4 CIT occurred will be continued at the same planned doses for a maximum of 8 courses.
* ECOG performance status score \</= 3.
* Adequate bone marrow function (ANC \>1.000; Hb \>9,5 g/dL; PLT \> 75.000).
Exclusion Criteria:
* Patients eligible for high-dose chemotherapy, where stem cell support is planned.
* Thrombotic events in the previous 5 years before enrolment.
* Other malignancies diagnosed in the previous 5 years before enrolment.
* Severe concomitant illnesses/medical conditions (e.g. impaired respiratory and/or cardiac function, uncontrolled diabetes mellitus).
* Active infectious disease.
* Impaired liver function (bilirubin \>2 x upper normal limit; ALT/AST/GGT \> 3 x upper normal limit) at one month from salvage chemotherapy conclusion.
* Impaired renal function (creatinine clearance \<50 ml/min) at one month from salvage chemotherapy conclusion.
* Non-cooperative behavior or non-compliance.
* Psychiatric diseases or conditions that might impair the ability to give informed consent.
* Pregnant or lactating females.
* Previous therapy with any TPO-mimetic or similar substances.…
What they're measuring
1
safety
Timeframe: participants will be followed for the duration of experimental treatment, an expected average of 6 months