CLINICAL TRIAL

Axicabtagene Ciloleucel for Lymphoma, B-Cell

Waitlist Available · 18+ · All Sexes · Tampa, FL

This study is evaluating whether a new type of treatment for lymphoma works.

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About the trial for Lymphoma, B-Cell

Eligible Conditions
B-cell Lymphoma · Lymphoma, B-Cell · Lymphoma

Treatment Groups

This trial involves 2 different treatments. 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Axicabtagene Ciloleucel
BIOLOGICAL
Fludarabine
DRUG
Cyclophosphamide
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
FDA approved
Cyclophosphamide
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
(CIT) A person must have a positive interim PET scan after 2 cycles of chemoimmunotherapy according to Cheson, 2014 show original
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 is an indicator of how well a person is doing following cancer treatment show original
A neutrophil count of 1000 or more per microliter is considered high. show original
ALT and AST levels that are two and a half times the upper limit of normal are considered safe. show original
There is no evidence that the person has a CNS involvement of lymphoma show original
is seen In medical terms, histologically confirmed large B-cell lymphoma refers to a specific type of cancerous tumor that is found in the lymphatic system show original
High-grade large B-cell lymphoma
Platelet count ≥ 75,000/μL
This means that the person's lymphocyte count is at least 100 cells per microliter. show original
Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL/min
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 5 years
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 5 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 5 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Axicabtagene Ciloleucel will improve 1 primary outcome and 9 secondary outcomes in patients with Lymphoma, B-Cell. Measurement will happen over the course of Up to 1 year.

Levels of cytokines in serum
UP TO 1 YEAR
UP TO 1 YEAR
Levels of anti-CD19 CAR T cells in blood
UP TO 1 YEAR
UP TO 1 YEAR
Duration of Response (DOR)
UP TO 2 YEARS
DOR is defined only for participants who experience an objective response after axicabtagene ciloleucel infusion and is the time from the first objective response to disease progression or death from any cause.
UP TO 2 YEARS
Objective Response Rate (ORR)
UP TO 2 YEARS
ORR is defined as the incidence of either a CR or a partial response (PR) per the Lugano Classification as determined by study investigators.
UP TO 2 YEARS
Complete Response (CR) Rate
UP TO 2 YEARS
Complete Response rate is defined as the incidence of a CR per the Lugano Classification (Cheson et al, 2014), as determined by study investigators.
UP TO 2 YEARS
Progression-Free Survival (PFS)
UP TO 2 YEARS
PFS is defined as the time from the axicabtagene ciloleucel infusion date to the date of disease progression or death from any cause.
UP TO 2 YEARS
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is lymphoma, b-cell?

Lymphoma, b-cell generally presents with lymph node involvement along with skin lesions, gastrointestinal or pulmonary symptoms, and low grade fever. The prognosis of the disease is generally poor. Lymphoma, b-cell is a heterogenous group of cancers and therefore, it is the primary topic of future studies.

Anonymous Patient Answer

What are common treatments for lymphoma, b-cell?

Many patients diagnosed with lymphoma receive more than one treatment. For older patients, the most common treatments are radiation, surgery, and chemotherapy, whereas for younger patients the most common treatments are chemotherapy, steroids, and immuno-targeted agents. It is important for patients and their treating physician or oncologist to ensure that the patient is informed regarding the most appropriate treatment based on their specific health status and the specific risks and benefits to be expected with each treatment.

Anonymous Patient Answer

What are the signs of lymphoma, b-cell?

Patients often have unusual symptoms of a rash, weight loss and swollen lymph nodes. Rarely the disease presents with blood in the urine or spinal fluid. Lymphoma, b-cell may be more common than previously thought and we recommend that patients may have a lymphoma screening programme.

Anonymous Patient Answer

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

Most lymphomas occur in older individuals and in men. More than half of cancer in infants, toddlers, and adolescents and about 20% of cancers in all children under 20 years of age are lymphomas. Nearly all infant and toddler lymphomas occur in children younger than 15 years of age. Almost 35% of cancers in teenagers or adults are lymphomas. Only about 20% of all lymphomas occurred in adults. The most common lymphomas in adults are diffuse large-cell lymphomas, and the second most common is mantle cell lymphoma. Most patients with lymphoma have B-cell histology.

Anonymous Patient Answer

What causes lymphoma, b-cell?

The cause of B-cell lymphoma is not entirely understood. It is thought that they develop when a cell overproduces immunoglobulins. When that cells fails to produce immunoglobulins for the body, that cell becomes cancerous. Factors that may influence development and progress of lymphoma include smoking, exposure to environmental toxins, infections, exposure to chemicals, genetic defects and mutations. Lymphoma is thought to appear when the lymphoid cells that produce antibodies are targeted for destruction by the immune system.

Anonymous Patient Answer

Can lymphoma, b-cell be cured?

Lymphomas of B-cell lineage, both T- and non-T-cell types, have a cure rate of 95.7%, but are invariably fatal. Lymphomas without an identifiable cell type may be cured with good and long-term survival. The presence of a second malignancy and the B-cell malignancy itself have no influence on prognosis. When lymphoma has been definitively diagnosed and is considered curable, further therapy is usually not necessary beyond prophylactic administration of (chemo) radiation to preserve a potentially normal immune system. For B-cell lymphomas, a protracted course of treatment with various chemotherapeutics and radiation is needed.

Anonymous Patient Answer

Has axicabtagene ciloleucel proven to be more effective than a placebo?

Ad-CTLA-4 induces a prolonged, durable response and long-term progression-free survival in adult patients with relapsed follicular CD19(+) B-cell non-Hodgkin lymphoma treated on an adjuvant regimen of rituximab and cyclophosphamide-CpE. This trial supports the role of treatment with Ad-CTLA-4 in the treatment of follicular CD19(+) B-cell lymphoma, a common subtype of B-cell malignancies.

Anonymous Patient Answer

How quickly does lymphoma, b-cell spread?

The current incidence of lymphoma is still increasing. Early detection is very important for optimal management. Clinical trials are needed to provide evidence for new treatments for lymphoma.

Anonymous Patient Answer

Is axicabtagene ciloleucel typically used in combination with any other treatments?

In a selected population of patients with follicular lymphoma, T-cell counts of < 30 000/µl at the start of treatment significantly predicts a lower response rate than those who are T-cell counts > and < 30 000/µl.

Anonymous Patient Answer

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

T-cells from patients with multiple myeloma are being tested in a clinical trial to treat lymphoma. It is important to understand how this therapy kills cells and to develop more effective ways to trigger a strong immune response so that the body attacks cancer cells. The next step would be testing how to maximize the immune response to attack cancer cells, especially the axicabtagene. The trial is studying cancer patients with multiple myeloma.

Anonymous Patient Answer

What does axicabtagene ciloleucel usually treat?

Axicabtagene Ciloleucel is a novel, selective immunotoxin with unique mechanisms of action. In addition, it has shown promise when given as a monotherapy and is being investigated as both a first- and second-line treatment in B-cell precursor ALL and CLL.

Anonymous Patient Answer

Have there been other clinical trials involving axicabtagene ciloleucel?

Axicabtagene ciloleucel is a promising new drug to be tested in future trials for patients with B-cell malignancies, and as an outpatient treatment over an extended period of time.

Anonymous Patient Answer
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