Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Theradex
OBJECTIVES: * Determine the antitumor activity of pixantrone, cytarabine, methylprednisolone, and cisplatin in patients with aggressive non-Hodgkin's lymphoma in first relapse. * Determine the safety and tolerability of this regimen in these patients. * Determine the validity and safety of this regimen as a mobilization regimen before high-dose chemotherapy with stem cell support in these patients. OUTLINE: This is an open-label, multicenter study. * Salvage therapy: Patients receive pixantrone IV over 1 hour on day 1; cisplatin IV over 30 minutes on days 1-4; methylprednisolone IV over 15-30 minutes on days 1-5; and cytarabine IV over 2 hours on day 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After 2 courses of salvage therapy, patients are re-evaluated and treated as follows: * Complete response (CR) or partial response (PR): Patients with a CR or PR who are suitable candidates for autologous stem cell transplantation (ASCT) proceed to mobilization therapy, high-dose chemotherapy, and ASCT. Patients with a CR or PR who are unsuitable candidates for ASCT continue to receive salvage therapy for up to 6 courses in the absence of disease progression or unacceptable toxicity. * Stable disease: Patients with stable disease continue to receive salvage therapy for up to 6 courses. Patients who have a CR or PR after 3-4 courses of salvage therapy and who are suitable candidates for ASCT proceed to mobilization therapy, high-dose chemotherapy, and ASCT off study at the investigator's discretion. * Mobilization therapy (optional regimen; regimen used for mobilization is at the investigator's discretion): Patients receive rituximab\* IV on days 1 and 7; pixantrone IV over 1 hour on day 2; cisplatin IV over 30 minutes on days 2-5; cytarabine IV over 2 hours on day 6; and methylprednisolone IV over 15-30 minutes on days 2-6. Patients also receive filgrastim (G-CSF) subcutaneously once daily beginning on day 7 and continuing until blood counts recover. Patients receive 1 or more courses of mobilization therapy during which stem cells are harvested. Patients then proceed to high-dose chemotherapy and subsequent re-infusion of harvested stem cells. NOTE: \*If this mobilization regimen is used, patients with T-cell lymphoma do not receive rituximab * High-dose chemotherapy and ASCT: Patients receive high-dose chemotherapy and ASCT per institutional standard practice. Patients are followed every 3 months for 2 years. PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
