NCT03003546

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2019

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 28, 2016

Completed
2.3 years until next milestone

Study Start

First participant enrolled

April 25, 2019

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2023

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

4.1 years

First QC Date

December 22, 2016

Last Update Submit

June 13, 2023

Conditions

Recurrent Aggressive Non-Hodgkin LymphomaRecurrent B-Cell Non-Hodgkin LymphomaRecurrent Small Lymphocytic LymphomaRefractory Aggressive Non-Hodgkin LymphomaRefractory B-Cell Non-Hodgkin LymphomaRefractory Small Lymphocytic Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose (MTD)

    MTD will be defined as the highest dose level patients develop a dose limiting toxicity assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The maximum grade of each type of toxicity will be recorded for each patient. For each toxicity reported by dose level, the percentage of patients developing any degree of that toxicity as well as the percentage of patients developing a severe degree (grade 3 or higher) will be determined.

    Up to 28 days

Secondary Outcomes (3)

  • Tumor response

    Up to 2 years

  • Progression free survival

    Time from registration to the earliest date of documentation of disease progression or death due to any cause, assessed up to 2 years

  • Overall survival

    Time from registration to death due to any cause, assessed up to 2 years

Study Arms (1)

Treatment (AR160)

EXPERIMENTAL

Patients receive nab-paclitaxel/rituximab-coated nanoparticle AR160 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.

Other: Laboratory Biomarker AnalysisDrug: Nab-paclitaxel/Rituximab-coated Nanoparticle AR160Other: Pharmacological Study

Interventions

Laboratory Biomarker AnalysisOTHER

Correlative studies

Treatment (AR160)
Nab-paclitaxel/Rituximab-coated Nanoparticle AR160DRUG

Given IV

Also known as: Abraxane coated with Rituximab, Abraxane Coated with Rituximab 160nm Nanoparticle, Abraxane/Rituxan 160 Complex, AR160
Treatment (AR160)
Pharmacological StudyOTHER

Correlative studies

Treatment (AR160)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>= 18 years.
  • Histological confirmation of relapsed/refractory B-cell NHL, CD20+
  • NOTE: patients with small lymphocytic lymphoma (SLL) are eligible however patients with chronic lymphocytic leukemia (CLL) are not eligible
  • Waldenstrom macroglobulinemia patients are not eligible; aggressive lymphoma patients who are transplant eligible must have undergone a transplant
  • The biopsy confirming relapse can be up to 24 weeks prior to registration as long as there is no intervening therapy
  • Measurable disease (at least 1 lesion of \>= 1.5 cm in one diameter) as detected by computed tomography (CT) or the CT images of the positron emission tomography (PET)/CT. Skins lesions can be used if the area is greater than or equal to 2 cm in at least one diameter and photographed with a ruler
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
  • Absolute neutrophil count (ANC) \>= 1500/mm\^3 (obtained =\< 14 days prior to registration)
  • Platelet count \>= 75,000/mm\^3 (obtained =\< 14 days prior to registration)
  • Hemoglobin \>= 8.0 g/dL (obtained =\< 14 days prior to registration)
  • Total bilirubin =\< 1.5 X upper limit of normal (ULN) or if total bilirubin is \> 1.5 X ULN, the direct bilirubin =\< ULN (obtained =\< 14 days prior to registration)
  • Alkaline phosphatase =\< 3 X ULN unless due to direct lymphoma involvement, and then =\< 5 X ULN (obtained =\< 14 days prior to registration)
  • Aspartate transaminase (AST) =\< 3 X ULN unless due to direct lymphoma involvement, and then =\< 5 X ULN (obtained =\< 14 days prior to registration)
  • Calculated creatinine clearance must be \>= 30 ml/min using the Cockcroft-Gault formula (obtained =\< 14 days prior to registration)
  • Life expectancy \>= 3 months
  • +7 more criteria

You may not qualify if:

  • Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
  • Pregnant women
  • Nursing women
  • Men or women of childbearing potential who are unwilling to employ adequate contraception
  • Active central nervous system (CNS) lymphoma or cerebrospinal fluid involvement with malignant lymphoma cells that requires therapy
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Received most recent therapy =\< 4 weeks prior to registration; NOTE: use of systemic steroid therapy is allowed pretreatment
  • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
  • Patients with \>= 25% of the bone marrow radiated for other diseases
  • Other medical conditions including but not limited to:
  • History of liver disease such as cirrhosis, chronic active hepatitis, chronic persistent hepatitis or hepatitis B or C
  • Active infection requiring parenteral antibiotics
  • New York Heart Association class II-IV congestive heart failure (serious cardiac arrhythmia requiring medication)
  • Myocardial infarction or unstable angina =\< 6 months prior to registration
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Lymphoma, B-CellLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

130-nm albumin-bound paclitaxelRituximabNanoparticlesAlbumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsNanostructuresManufactured MaterialsTechnology, Industry, and AgriculturePaclitaxelTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAlbumins

Study Officials

  • Thomas M Habermann

    Mayo Clinic in Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2016

First Posted

December 28, 2016

Study Start

April 25, 2019

Primary Completion

May 16, 2023

Study Completion

May 16, 2023

Last Updated

June 15, 2023

Record last verified: 2023-06

Locations

US(1)