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Recurrent Aggressive Non-Hodgkin LymphomaPhase 1NCT03003546

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

A Phase 1 study testing Laboratory Biomarker Analysis, Nab-paclitaxel/Rituximab-coated Nanoparticle AR160 and Pharmacological Study in people with Recurrent Aggressive Non-Hodgkin Lymphoma and Recurrent B-Cell Non-Hodgkin Lymphoma, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Laboratory Biomarker Analysis, Nab-paclitaxel/Rituximab-coated Nanoparticle AR160 and Pharmacological Study
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteUnited States
Study dates
25 Apr 2019to 16 May 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • Ability to provide written informed consent
  • Willing to return to enrolling institution for follow-up (during the treatment phase of the study)
  • Willing to provide blood samples for correlative research purposes
  • Failed or are intolerant to 2 or more lines of established therapy or for whom no other treatment options are available in the opinion of the investigator
  • Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
  • Disease-free of prior invasive malignancies for > 5 years prior to registration
  • Note: Exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix

Who cannot join

  • 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
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  • 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
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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:

  1. 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.

Being tested
Laboratory Biomarker Analysis, Nab-paclitaxel/Rituximab-coated Nanoparticle AR160, Pharmacological Study
Medical subject headings
Lymphoma, B-Cell, Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Nab-paclitaxel/Rituximab-coated Nanoparticle AR160Drug

    Also called Abraxane coated with Rituximab, Abraxane Coated with Rituximab 160nm Nanoparticle, Abraxane/Rituxan 160 Complex, AR160

    Given IV

  • Pharmacological StudyOther

    Correlative studies

Study groups in NCT03003546
Study groupRoleWhat they receive
Treatment (AR160)ExperimentalPatients 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.
Receives: Other: Laboratory Biomarker Analysis; Drug: Nab-paclitaxel/Rituximab-coated Nanoparticle AR160; Other: Pharmacological Study

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 28 days

Secondary outcomes (3)

  1. Tumor response

    Will be assessed using the Lugano Classification Response criteria. A table will be constructed to display by dose level, the number of patients treated at that dose level, the number of cycles of treatment administered, dose limiting toxicity (DLT) observed, and number of responses.

    Measured: Up to 2 years

  2. Progression free survival

    The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.

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

  3. Overall survival

    The distribution of overall survival will be estimated using the method of Kaplan Meier.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2016 (estimated)
  2. Study start25 Apr 2019
  3. Primary completion16 May 2023
  4. Study completion16 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03003546
Sponsor's protocol ID
LS1681
Other IDs
NCI-2016-01984, P50CA097274
Status last verified
Jun 2023
First submitted
22 Dec 2016
Last updated
15 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Laboratory Biomarker Analysis, Nab-paclitaxel/Rituximab-coated Nanoparticle AR160 and Pharmacological Study in people with Recurrent Aggressive Non-Hodgkin Lymphoma and Recurrent B-Cell Non-Hodgkin Lymphoma, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03003546.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.

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