Axicabtagene Ciloleucel for Refractory Large B-cell Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Chicago Medical Center, Chicago, IL
Refractory Large B-cell Lymphoma+2 More
Axicabtagene Ciloleucel - Biological
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new type of treatment for lymphoma works better than the standard treatment.

See full description

Eligible Conditions

  • Refractory Large B-cell Lymphoma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Axicabtagene Ciloleucel will improve 1 primary outcome and 6 secondary outcomes in patients with Refractory Large B-cell Lymphoma. Measurement will happen over the course of Time Frame: Up to 2 years.

Year 2
Objective Response Rate (ORR)
Up to 15 years
Overall Survival (OS)
Percentage of Participants Experiencing Adverse Events and Clinically Significant Changes in Safety Lab Values
Up to 2 years
Complete Response (CR) Rate
Duration of Response (DOR)
Levels of Axicabtagene Ciloleucel in Blood
Progression-Free Survival (PFS)

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

1 Treatment Group

Axicabtagene Ciloleucel and Rituximab Combination
1 of 1
Experimental Treatment

This trial requires 27 total participants across 1 different treatment group

This trial involves a single treatment. Axicabtagene Ciloleucel 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 2 and have already been tested with other people.

Axicabtagene Ciloleucel and Rituximab CombinationParticipants will receive rituximab, and fludarabine and cyclophosphamide conditioning chemotherapy, followed by axicabtagene ciloleucel and additional rituximab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
FDA approved
Fludarabine
FDA approved
Cyclophosphamide
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 15 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 15 years for reporting.

Closest Location

University of Chicago Medical Center - Chicago, IL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Refractory Large B-cell Lymphoma or one of the other 2 conditions listed above. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
No response to second or greater lines of therapy OR Refractory after autologous stem cell transplant (ASCT)
At least 1 measureable lesion according to the Lugano Classification (Cheson 2014).
Anti-CD20 monoclonal antibody
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Key
Histologically confirmed large B-cell lymphoma
No response to first-line therapy (primary refractory disease)
An anthracycline-containing chemotherapy regimen
Adequate renal, hepatic, pulmonary, and cardiac function

Patient Q&A Section

What causes lymphoma, b-cell?

"The majority of DLBCLs appear to have a specific genetic abnormality. Although the most common abnormality in mantle cell lymphoma is a translocation between chromosomes 14 and 22, the pathogenetic pathways by which this translocation occurs are currently unknown." - Anonymous Online Contributor

Unverified Answer

What is lymphoma, b-cell?

"lymphoma, B-cell is a type of lymphoma and one of the most common types in the body. Lymphoma accounts for about 5 percent of all cancers in adult humans. In most cases, lymphoma is associated with either a rapid enlargement of lymphoid organs or with lymphocytic infiltration of extra-nodal organs. As lymphoma is not one disease we can say that it is a disease in many ways." - Anonymous Online Contributor

Unverified Answer

How many people get lymphoma, b-cell a year in the United States?

"3.8 million people are diagnosed with NHL annually, making up 9.4% of the total American population. Lymphoma, b-cell is the most common of the NHL and accounts for 7.5% of the total American population." - Anonymous Online Contributor

Unverified Answer

What are the signs of lymphoma, b-cell?

"The following signs are typical of B-cell malignancies that can be identified on the basis of physical findings or medical history. The diagnosis of Hodgkin's disease in any stage is suspected on the basis of symptoms such as fever, weight loss, night sweats, and enlarged lymph nodes. Symptoms do not have to be well defined in order for a diagnosis to be made.\n\nIt can also be a sign of non-Hodgkin's disease or of non-B-cell non-Hodgkin's disease." - Anonymous Online Contributor

Unverified Answer

Can lymphoma, b-cell be cured?

"Lymphoma, b-cell is frequently curable during the initial course of the disease, but recurrence in the majority of patients occurs during and after treatment. The 5-year survival rate is higher than that of other solid tumors." - Anonymous Online Contributor

Unverified Answer

What are common treatments for lymphoma, b-cell?

"To treat lymphoma, B-cell, there is no cure other than chemotherapy. Chemotherapy is efficient and is used as a first line therapy for the cancer. But chemotherapy has side effects such as nausea, vomiting, hair loss, etc... And B-cell lymphoma is very aggressive. Therefore, the treatment for cancer lymphoma is not as good as using drug-naive, but only use chemotherapy." - Anonymous Online Contributor

Unverified Answer

What is axicabtagene ciloleucel?

"Results from a recent clinical trial of this analysis have been published in a "pre-labeled clinical trial announcement " from the U.S. Food and Drug Administration. In this article, we describe in detail the design, results, and conclusions, but omit some of the background on the development of axicabtagene ciloleucel. This is an important step to a fuller understanding of Axl. In summary, results suggest Axl is at least equally efficacious as first generation inhibitors against FLT3-ITD, but are slightly less efficacious than gilotinib in the treatment of patients with advanced FLT3-ITD." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of axicabtagene ciloleucel?

"Side effects of brentuximab vedotin in patients with unresectable, advanced follicular lymphoma were generally manageable. However, axicabtagene ciloleucel-related serious adverse events may occur during both the dose-dense and weekly schedules of administration. Physicians should be aware of these side effects and monitor patients routinely when patients receive axicabtagene ciloleucel." - Anonymous Online Contributor

Unverified Answer

Does axicabtagene ciloleucel improve quality of life for those with lymphoma, b-cell?

"Overall and on-treatment improvement in [QOL] was observed in patients with newly diagnosed or relapsed diffuse large B-cell lymphoma treated with axicabtagene ciloleucel. This effect was sustained throughout the study in general and disease-specific QOL domains. Overall and disease-specific QOL improvement correlated with overall and disease-specific [EQ-5D-5L] scores. Patient-reported [EQ-5D-5L] scores correlated with clinical measures of disease activity and response during the trial. Clin Cancer Res; 1-14. ©2016 AACR." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in axicabtagene ciloleucel for therapeutic use?

"AXL was well-tolerated with few infusion-associated adverse events. It resulted in durable responses, which correlated with AXL's ability to induce cell-death by abrogating tumor signaling within B-cells. As AXL is a novel treatment, validation studies are under way for further exploration in patients with DLBCL, mantle cell lymphoma, asymptomatic B-cell chronic lymphocytic leukemias, and follicular lymphoma." - Anonymous Online Contributor

Unverified Answer

What does axicabtagene ciloleucel usually treat?

"In this case series, patients with B-cell lymphoma and a good response to preceding therapies had the best outcomes, and patients with other diseases did not. In a recent study, findings warrant further research to guide treatment choices for patients with B-cell lymphoma." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving axicabtagene ciloleucel?

"The first phase III trial showed that axicabtagene ciloleucel elicited a promising clinical benefit in CLL and MM patients, while maintaining an acceptable safety profile." - 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.
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