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
|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|
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)
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.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
Drug: Nab-paclitaxel/Rituximab-coated Nanoparticle AR160
Other Name: AR160
Other: Pharmacological Study
- 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.
- 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.
- 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.
- 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.
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
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Clinical Trials Referral Office 855-776-0015|
|Principal Investigator: Thomas M. Habermann|
|Principal Investigator:||Thomas Habermann||Mayo Clinic|