Status:
COMPLETED
Secondary Prophylaxis in Non-Hodgkin Lymphoma (NHL) and Chemotherapy-induced Thrombocytopenia
Lead Sponsor:
Andres J. M. Ferreri
Collaborating Sponsors:
Amgen
Conditions:
Non-Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
High-dose chemotherapy followed by autologous stem cell transplant is considered standard of care for patients with relapsed and/or refractory aggressive lymphomas. High-dose chemotherapy, with or wit...
Eligibility Criteria
Inclusion
- 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
- 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.
- Previous therapy supported by transplant of autologous or allogeneic stem cells
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01516619
Start Date
November 1 2011
End Date
November 1 2012
Last Update
August 12 2022
Active Locations (1)
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1
Dip. Oncoematologia - Fondazione Centro San Raffaele del Monte Tabor
Milan, Italy