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

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ClinicalTrials.gov Identifier: NCT03003546
Recruitment Status : Recruiting
First Posted : December 28, 2016
Last Update Posted : August 6, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Study Description
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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 or is not responding to treatment. 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. Monoclonal antibodies, such as rituximab, 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.

Condition or disease Intervention/treatment Phase
Aggressive Non-Hodgkin Lymphoma CD20 Positive Recurrent B-Cell Non-Hodgkin Lymphoma Recurrent Small Lymphocytic Lymphoma Refractory B-Cell Non-Hodgkin Lymphoma Refractory Small Lymphocytic Lymphoma Other: Laboratory Biomarker Analysis Drug: Nab-paclitaxel/Rituximab-coated Nanoparticle AR160 Other: Pharmacological Study Phase 1

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Trial of AR160 (Abraxane/Rituximab 160nm Nanoparticle) in Relapsed/Refractory B Cell Lymphomas Including Transformed Follicular Lymphoma
Actual Study Start Date : April 25, 2019
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment (AR160)
Patients receive nab-paclitaxel/rituximab-coated nanoparticle AR160 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.
 Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Nab-paclitaxel/Rituximab-coated Nanoparticle AR160
Given IV
Other Name: AR160

Other: Pharmacological Study
Correlative studies


Outcome Measures
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Primary Outcome Measures :
  1. MTD defined as the highest dose level patients develop a dose limiting toxicity assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 28 days ]
    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.


Secondary Outcome Measures :
  1. OS [ Time Frame: Up to 5 years ]
    A table will be constructed to display by dose level, the number of patients treated at that dose level, the number of cycle of treatment administered, DLT observed, progression-free survival time and overall survival time.

  2. PFS [ Time Frame: Up to 5 years ]
    A table will be constructed to display by dose level, the number of patients treated at that dose level, the number of cycle of treatment administered, DLT observed, progression-free survival time and overall survival time.

  3. Tumor response assessed using The Lugano Classification Response criteria [ Time Frame: Up to 5 years ]
    A table will be constructed to display by dose level, the number of patients treated at that dose level, the number of cycle of treatment administered, DLT observed, progression-free survival time and overall survival time.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
  • Absolute neutrophil count (ANC) >= 1500/mm^3
  • Platelet count >= 75,000/mm^3
  • Hemoglobin >= 8.0 g/dL
  • Total bilirubin =< 1.5 X upper limit of normal (ULN) or if total bilirubin is > 1.5 X ULN, the direct bilirubin =< ULN
  • Alkaline phosphatase =< 3 X ULN unless due to direct lymphoma involvement, and then =< 5 X ULN
  • Aspartate transaminase (AST) =< 3 X ULN unless due to direct lymphoma involvement, and then =< 5 X ULN
  • Calculated creatinine clearance must be >= 30 ml/min using the Cockcroft-Gault formula
  • Life expectancy >= 3 months
  • Ability to provide written informed consent
  • Willing to return to enrolling institution for follow-up (during the treatment and observation phases of the study)
  • Willing to provide tissue for central review blood samples for correlative research purposes
  • No other therapy with demonstrated clinical benefit in relapsed/refractory B-cell NHL available to the patient
  • Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only

Exclusion Criteria:

  • Any of the following:

    • 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
  • Patients who 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 must be disease-free of prior invasive malignancies for > 5 years prior to registration with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
  • 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
    • Congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
    • Clinically significant peripheral vascular disease
    • History of CNS disease (e.g., primary brain tumor, vascular abnormalities, etc.), clinically significant stroke or transient ischemic attack (TIA) =< 6 months prior to registration, seizures not controlled with standard medical therapy
    • Neuropathy ˃ grade 3
  • Administration of strong CYP2C8 or CYP3A4 inhibitors or inducers =< 10 days prior to registration
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03003546


Locations
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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Referral Office    855-776-0015      
Principal Investigator: Thomas M. Habermann         
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Thomas Habermann Mayo Clinic
More Information
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Additional Information:

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Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT03003546    
Other Study ID Numbers: LS1681
NCI-2016-01984 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
LS1681 ( Other Identifier: Mayo Clinic )
P30CA015083 ( U.S. NIH Grant/Contract )
First Posted: December 28, 2016    Key Record Dates
Last Update Posted: August 6, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Leukemia, Lymphoid
Leukemia
 Paclitaxel
Rituximab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents