NCT03003546

Nab-paclitaxel/Rituximab-coated Nanoparticle AR160 in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma, LS1681 Trial

LS1681: A Phase I Trial of AR160 (Abraxane/Rituximab 160nm Nanoparticle) in Relapsed/Refractory B Cell Lymphomas Including Transformed Follicular Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the best dose and side effects of paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel)/rituximab-coated nanoparticle AR160 in treating patients with B-cell non-Hodgkin lymphoma that has come back (relapsed) or is not responding to treatment (refractory). Nab-paclitaxel/rituximab-coated nanoparticle AR160 is a combination of paclitaxel albumin-stabilized nanoparticle formulation and rituximab. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with rituximab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving paclitaxel albumin-stabilized nanoparticle formulation and rituximab may work better in treating patients with B-cell non-Hodgkin lymphoma.

Detailed description

PRIMARY OBJECTIVE: 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. CORRELATIVE RESEARCH OBJECTIVE: 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). As of Amendment 4, PKs will no longer be collected. 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. Cycles repeat every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for up to 2 years.

Conditions

• Recurrent Aggressive Non-Hodgkin Lymphoma
• Recurrent B-Cell Non-Hodgkin Lymphoma
• Recurrent Small Lymphocytic Lymphoma
• Refractory Aggressive Non-Hodgkin Lymphoma
• Refractory B-Cell Non-Hodgkin Lymphoma
• Refractory Small Lymphocytic Lymphoma

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Nab-paclitaxel/Rituximab-coated Nanoparticle AR160	Given IV
OTHER	Pharmacological Study	Correlative studies

Timeline

• Start date: 2019-04-25
• Primary completion: 2023-05-16
• Completion: 2023-05-16
• First posted: 2016-12-28
• Last updated: 2023-06-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study