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

NCT03003546 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2023-06-15

No results posted yet for this study

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.

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

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Nab-paclitaxel/Rituximab-coated Nanoparticle AR160

Given IV

OTHER

Pharmacological Study

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Thomas M Habermann · Mayo Clinic in Rochester

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-25
Primary Completion
2023-05-16
Completion
2023-05-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03003546 on ClinicalTrials.gov