Nab-paclitaxel/Rituximab-coated Nanoparticle AR160 in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

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PRIMARY OBJECTIVES: I. To establish the maximum tolerated dose (MTD) of nab-paclitaxel/rituximab-coated nanoparticle AR160 (AR160) in patients with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL). (Phase I) SECONDARY OBJECTIVES: I. To assess the toxicity and safety of AR160. II. To assess comp...

PRIMARY OBJECTIVES: I. To establish the maximum tolerated dose (MTD) of nab-paclitaxel/rituximab-coated nanoparticle AR160 (AR160) in patients with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL). (Phase I) SECONDARY OBJECTIVES: I. To assess the toxicity and safety of AR160. II. To assess complete response rate (CR) progression free survival (PFS), and overall survival (OS) of AR160 with relapsed/refractory B-cell NHL. TERTIARY OBJECTIVES: I. Evaluate pharmacokinetics (PK) of AR160 in two formal PK studies, dose 1 of cycle 1 (48 hours [h] PK analysis) and dose 1 of cycle 2 (24h PK analysis). OUTLINE: This is a dose-escalation study. Patients receive nab-paclitaxel/rituximab-coated nanoparticle AR160 intravenously (IV) over 30-60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for up to 5 years.

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