Secondary Prophylaxis in Non-Hodgkin Lymphoma (NHL) and Chemotherapy-induced Thrombocytopenia

• Status: Unknown status
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Andres J. M. Ferreri
• Collaborator: Amgen

Criteria

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
• 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.

• Previous therapy supported by transplant of autologous or allogeneic stem cells