Nab-paclitaxel/Rituximab-coated Nanoparticle AR160 for Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Mayo Clinic, Rochester, MN
Lymphoma+10 More
Nab-paclitaxel/Rituximab-coated Nanoparticle AR160 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a combination of paclitaxel and rituximab might be more effective than paclitaxel alone in treating patients with B-cell non-Hodgkin lymphoma.

See full description

Eligible Conditions

  • Lymphoma
  • Aggressive Non-hodgkin Lymphoma (aNHL)
  • Refractory Small Lymphocytic Lymphoma
  • Recurrent Small Lymphocytic Lymphoma
  • Refractory B-Cell Non-Hodgkin Lymphoma
  • Recurrent B-Cell Non-Hodgkin Lymphoma
  • CD20 Positive

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Nab-paclitaxel/Rituximab-coated Nanoparticle AR160 will improve 1 primary outcome and 3 secondary outcomes in patients with Lymphoma. Measurement will happen over the course of Up to 28 days.

Up to 28 days
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
Up to 5 years
OS
PFS
Tumor response assessed using The Lugano Classification Response criteria

Trial Safety

Trial Design

1 Treatment Group

Treatment (AR160)
1 of 1
Experimental Treatment

This trial requires 18 total participants across 1 different treatment group

This trial involves a single treatment. Nab-paclitaxel/Rituximab-coated Nanoparticle AR160 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 5 years for reporting.

Closest Location

Mayo Clinic - Rochester, MN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Lymphoma or one of the other 10 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Hemoglobin >= 8.0 g/dL
The bilirubin level must be less than 1.5 times the upper limit of normal, or if it is greater than 1.5 times the upper limit of normal, the direct bilirubin must be less than the upper limit of normal. show original
The level of alkaline phosphatase is less than three times the upper limit of normal (ULN) unless it is due to direct lymphoma involvement, in which case it is less than five times the ULN. show original
Waldenstrom macroglobulinemia patients are not eligible for a transplant show original
This text is about a person who has relapsed or refractory B-cell NHL, which is a type of cancer show original
Patients with SLL are eligible for the study, but patients with CLL are not eligible. show original
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
This means that the absolute neutrophil count must be greater than or equal to 1,500 per cubic millimeter. show original
A platelet count of at least 75,000 per millimeter is considered normal. show original

Patient Q&A Section

Can lymphoma, diffuse be cured?

"As is the case with most cancers, lymphoma responds favorably to multimodal therapy, but long-term results remain poor. The therapeutic protocols developed for diffuse large B-cell lymphoma must be revised in light of our findings that, despite the frequent use of anthracyclines, only 2/39 patients in the no-treatment group received this agent." - Anonymous Online Contributor

Unverified Answer

What are common treatments for lymphoma, diffuse?

"The most common treatment for both DLBCL and indolent NHL types is chemotherapy; this includes most chemotherapy regimens for NHL. Radiation therapy is also used for patients ineligible for chemotherapy or those with progressive or recurrent disease. Lymphoma, indolent NHL, treatment, and chemotherapy, radiation therapy, surgery, and lymphoma staging." - Anonymous Online Contributor

Unverified Answer

How many people get lymphoma, diffuse a year in the United States?

"The rate of lymphomas presenting as DLB seems to be increasing. However, the increasing rate could be due to increased awareness of DLB or increased use of imaging for DLB, rather than an actual increase in the incidence or duration of DLB." - Anonymous Online Contributor

Unverified Answer

What are the signs of lymphoma, diffuse?

"Lymphoma, diffuse presents itself as an enlarged lymph node in the cervical, mediastinal, or inguinal region, but can also be found in other sites. The signs of lymphoma, diffuse often require several tests to be done to verify the diagnosis.\n" - Anonymous Online Contributor

Unverified Answer

What causes lymphoma, diffuse?

"The main risk factors, at least for lymphoma, diffuse were [male, > 60 years old, previous infectious diseases, and no treatment for P. vivax parasites]." - Anonymous Online Contributor

Unverified Answer

What is lymphoma, diffuse?

"Lymphoma, diffuse, commonly called non-Hodgkin lymphoma, diffuse, is a form of Non-Hodgkin lymphoma originating mostly in the bone marrow and/other tissues in lymphoid tissues. Its symptoms include fever, weight loss, swelling in the neck, or chest, skin lesions, loss of appetite, and a dry cough with weight loss. Tissue biopsies, blood tests, and radiological investigations can be performed to help with diagnosis and to assess whether the cancer is in remission or has become aggressive. The disease is not treated with chemotherapeutic agents because many people with the disease will succumb to the progressive disease before treatment achieves therapeutic benefit." - Anonymous Online Contributor

Unverified Answer

Does nab-paclitaxel/rituximab-coated nanoparticle ar160 improve quality of life for those with lymphoma, diffuse?

"Nab-paclitaxel/rituximab-coated ar160 appears to improve the survival of patients with DLBCL on the current standard of care. This improvement in treatment outcomes was not significantly dependent on patient age or gender, suggesting the promise of broader applicability across clinical sub-types. Recent findings support the development of further ar160-based nanoparticle treatments for this patient population." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in nab-paclitaxel/rituximab-coated nanoparticle ar160 for therapeutic use?

"Nab-paclitaxel/rituximab nanoparticles, formulated from poly(lactic-co-glycolic acid), show promising results of antitumor action in vitro and in vivo and warrant further clinical evaluation in this regard." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for lymphoma, diffuse?

"Overall survival rates for patients with DLBCL, diffuse are very low; approximately 14% and 16%, and 18% and 19% for PCDH and DLBCL, follicular, diffuse after 4 years' and 5 years' follow-up, respectively, but the difference is not statistically significant." - Anonymous Online Contributor

Unverified Answer

Is nab-paclitaxel/rituximab-coated nanoparticle ar160 safe for people?

"Ar160 is safe and well tolerated in people with lymphoma in phase II and III studies. It is undergoing phase III trials in DLBCL, CLL, HL, and DLPCL. It is a promising second-line strategy for CLL and DLPCL. A Phase I Trial in rrAML (NCT02079346) is planned. summary: Results from a recent clinical trial is exploring whether nab-paclitaxel/rituximab-coated nanoparticles are safe and effective for treatment of lymphoma." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of lymphoma, diffuse?

"The most probable cause of the lymphoma, diffuse, is due to a genetic condition, sporadic tumorigenesis, and the exposure to some other environmental factor(s). It is important always to do as much research as possible to avoid an under- or overdiagnosis of lymphoma, diffuse. However, one type of lymphoma, diffuse, is now very rare in the United States and appears to be on the decline because of increased awareness of and testing for this type of lymphoma. There are some interesting factors that make this lymphoma unlikely in some people. Some individuals who have lymphoma, diffuse, do not have a family history of the disease." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving nab-paclitaxel/rituximab-coated nanoparticle ar160?

"The first-in-human trial results of nab-paclitaxel/rituximab-coated ar160 support the use of nab-paclitaxel/rituximab as an effective therapeutic agent for the treatment of solid tumors, with no significant neurotoxicity. The combination of nab-paclitaxel and rituximab may become a new therapeutic option for cancers such as colon cancer." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Lymphoma by sharing your contact details with the study coordinator.