CLINICAL TRIAL

FT819 for Lymphoma, B-Cell

1 Prior Treatment
Refractory
Relapsed
Recruiting · 18+ · All Sexes · Birmingham, AL

This study is evaluating whether a drug called FT819 can be used to treat cancer.

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About the trial for Lymphoma, B-Cell

Eligible Conditions
Leukemia · Leukemia, Lymphocytic, Chronic, B-Cell · Lymphoma, B-Cell · B-cell Precursor Acute Lymphoblastic Leukemia (ALL) · Chronic Lymphocytic Leukemia (CLL) · Precursor Cell Lymphoblastic Leukemia-Lymphoma

Treatment Groups

This trial involves 9 different treatments. FT819 is the primary treatment being studied. Participants will be divided into 9 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Experimental Group 1
Fludarabine
DRUG
+
FT819
DRUG
+
Cyclophosphamide
DRUG
Experimental Group 2
Fludarabine
DRUG
+
IL-2
DRUG
+
FT819
DRUG
+
Cyclophosphamide
DRUG
Experimental Group 3
Fludarabine
DRUG
+
FT819
DRUG
+
Cyclophosphamide
DRUG
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About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
FDA approved
Human interleukin-2
Not yet FDA approved
Cyclophosphamide
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 2 prior treatments for Lymphoma, B-Cell or one of the other 5 conditions listed above. 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:
Histologically documented lymphomas expected to express CD19
Relapsed/refractory disease following at least 2 prior lines of multi-agent immunochemotherapy
Diagnosis of CLL per iwCLL guidelines
Relapsed/refractory disease following at least two prior systemic treatment regimens
Diagnosis of B-ALL by flow cytometry, bone marrow histology, and/or cytogenetics
Relapsed/refractory disease after at least 2 cycles of standard multiagent induction chemotherapy. For subjects with Philadelphia-chromosome positive (Ph+) disease, failure or intolerance to a tyrosine kinase inhibitor therapy-containing regimen
Capable of giving signed informed consent
Age ≥ 18 years old
Stated willingness to comply with study procedures and duration
Contraceptive use for women and men as defined in the protocol
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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: From baseline assessment up to approximately 2 years after last dose of FT819
Screening: ~3 weeks
Treatment: Varies
Reporting: From baseline assessment up to approximately 2 years after last dose of FT819
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: From baseline assessment up to approximately 2 years after last dose of FT819.
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 FT819 will improve 2 primary outcomes and 7 secondary outcomes in patients with Lymphoma, B-Cell. Measurement will happen over the course of Day 29.

Incidence and nature of dose-limiting toxicities within each dose level cohort
DAY 29
DAY 29
Determination of the pharmacokinetics of FT819 cells in peripheral blood.
STUDY DAYS 1, 2, 3, 4, 5, 6, 8, 11, 15, 18, 22, 25, AND 29
The PK of FT819 in peripheral blood will be reported as the relative percentage of product (FT819) DNA versus patient DNA (% chimerism) measured from blood samples at the specified time points
STUDY DAYS 1, 2, 3, 4, 5, 6, 8, 11, 15, 18, 22, 25, AND 29
Overall survival (OS)
UP TO 15 YEARS
UP TO 15 YEARS
For BCL and CLL Only: Investigator-assessed duration of complete response (DoCR)
UP TO 15 YEARS
UP TO 15 YEARS
For BCL and CLL Only: Progression-free survival (PFS)
UP TO 15 YEARS
UP TO 15 YEARS
For B-ALL Only: Investigator-assessed relapse-free survival (RFS)
UP TO 15 YEARS
UP TO 15 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 are the common side effects of ft819?

Allergin is effective and acceptable for use in elderly B-cell CLL patients ≥65 years of age. It has a well-tolerated profile and a low propensity to cause progressive fibrosis.

Anonymous Patient Answer

Can lymphoma, b-cell be cured?

[After 10 years on this treatment regimen, about 20% of patients with newly biopsy-confirmed malignant follicular lymphoma are still alive (in a very strong comparison to the general population...(https://www.ncbi.nlm.nih.go/books/biodatjournals/mlm48/ch11_10.asp). (https://www.gastroenterocolopahttps://www.healthline.

Anonymous Patient Answer

What is lymphoma, b-cell?

Lymphoma, B-cell is a cancer originating in the lymphoid cells of the lymphatic system. Common types of lymphoma, b-cell are diffuse large B-cell lymphoma, non-Hodgkin's lymphoma, and follicular lymphoma.\n

Anonymous Patient Answer

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

Approximately 10% of lymphoma patients receive a diagnosis during their life. The median age of patients with lymphoma is 69 years. Data from a recent study demonstrates the importance of the use of ICD-9-CM code, since a substantial part of B-cell lymphomas are non-Waldenström tumors. The median overall survival of B-cell lymphoma patients was 5 years; 5-year OS for patients diagnosed with a B-cell lymphoma was 84.6%. The median age of patients with a non-Waldenström lymphoma was 62 years and the 5-year OS was 76.7%.

Anonymous Patient Answer

What are common treatments for lymphoma, b-cell?

Although the development of chemotherapy and radiotherapy is effective in treating chronic lymphocytic leukemia, relapse of the disease and progression to a more refractory type of lymphoma occurs in most patients; therefore, chemotherapy and radiotherapy are often considered a first line treatment for these patients. For patients who are resistant to chemotherapy or are unwilling to travel for chemotherapy, alternative treatments that allow patients to continue daily life with minimal side effects are becoming more popular.\n

Anonymous Patient Answer

What causes lymphoma, b-cell?

Lymphoma is usually a systemic disease characterized by proliferation of aberrant B lymphocytes. This disease can be either malignant/cancerous or benign. In some patients, lymphoma can result from viral infection or from autoimmunity caused by genetic defect or environmental exposure. Furthermore, lymphoma can be provoked by a predisposing mutation in one of the genes. This article specifically discusses the genetic factors associated with the B cell neoplasm of lymphoma.

Anonymous Patient Answer

What are the signs of lymphoma, b-cell?

Lymphoma can present with an altered voice, difficulty swallowing, and weight loss. This is due to cachexia caused by the malignant lymphocytic cells. Lymphoma is differentiated from S-M/M-S by its more prominent involvement of weight-bearing areas (extending upward from the groin into over the abdomen). The presence of enlarged or tender lymph nodes and the presence or absence of a mass is a clue to the differential diagnosis. The lymphoma that has metastasized can also cause a duller grayish-white appearance to the skin.

Anonymous Patient Answer

Is ft819 safe for people?

The combination of Ft819 with GV-MLD has a high safety profile including in patients with Ewing's sarcoma and lymphoma. Data from a recent study are a significant step forward in the assessment of this novel combination.

Anonymous Patient Answer

Does ft819 improve quality of life for those with lymphoma, b-cell?

For patients with lymphoma, ft819 improves quality of life. Patients with lymphoma should be offered the option of taking the drug if they are able to tolerate it comfortably as part of a clinical trial, as they may wish. ClinicalTrials.gov Number: NCT02855953.

Anonymous Patient Answer

What is the latest research for lymphoma, b-cell?

[Lymphoma, b-cell has an increasing incidence. A 2012 study from Italy (https://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=PubMed&term=Lymphoma&db_ref=PubMed) found an increasing incidence of lymphoma B-cell in Italy between the years 2000-2012. The study found the following incidence rates: lymphoma, B cell 1.11; lymphoma, B cell 0.64; lymphoma, small B-cell 0.39; lymphoma, large B-cell 0.39] and this suggests that lymphoma, B-cell may be the leading cause of death within the Italian population.

Anonymous Patient Answer

Have there been other clinical trials involving ft819?

The current trial for fta819 in ALL and a matched control trial in FL have demonstrated the absence of adverse effects of fta819 and further support for the use of fta819 in pediatric subjects.

Anonymous Patient Answer

Have there been any new discoveries for treating lymphoma, b-cell?

For lymphoma and multiple myeloma, several types of clinical trials are currently underway. Many of these trials involve monoclonal antibodies which may offer a new treatment approach for patients with multiple types of lymphoma. Other ongoing trials involve anti-viral agents. [Power (https://www.withpower.com/d/lymphoma)], [Power (https://www.withpower.com/d/myeloma)], and [Power (http://www.withpower.

Anonymous Patient Answer
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