CLINICAL TRIAL

Biospecimen Collection for Lymphoma, B-Cell

1 Prior Treatment
Relapsed
Recruiting · Any Age · All Sexes · Seattle, WA

This study is evaluating whether a vaccine may help prevent infection in individuals who have undergone a specific type of immunotherapy.

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About the trial for Lymphoma, B-Cell

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

Treatment Groups

This trial involves 2 different treatments. Biospecimen Collection 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Wistar Rabies Virus Strain PM-1503-3M Vaccine
BIOLOGICAL
Biospecimen Collection
PROCEDURE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Wistar Rabies Virus Strain PM-1503-3M Vaccine
BIOLOGICAL
Biospecimen Collection
PROCEDURE

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Early Phase 1
~150

Eligibility

This trial is for patients born any sex of any age. You must have received 1 prior treatment for Lymphoma, B-Cell or the other condition listed above. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Patients who have had relapse-free survival for more than six months after receiving CARTx therapy for B-cell malignancies are eligible to receive CARTx therapy. show original
HEALTHY CONTROLS: Patients must be capable of understanding and providing a written informed consent
HEALTHY CONTROLS: Patients must be 18 years of age or older, of any gender, race or ethnicity
Patients who wish to receive CARTx must be able to understand and provide written informed consent, or if they are a minor, have both parents or legal guardians be able to provide informed consent on their behalf. show original
The following text is about the requirements for someone to be a CARTx recipient show original
People who have a platelet count of more than 30,000 mm3 are potentially CARTx recipients. show original
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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: 4 weeks after the secondary vaccination
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 weeks after the secondary vaccination
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 4 weeks after the secondary vaccination.
View detailed reporting requirements
Trial Expert
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- 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 Biospecimen Collection will improve 1 primary outcome and 4 secondary outcomes in patients with Lymphoma, B-Cell. Measurement will happen over the course of From baseline (prior to primary vaccination) through 6 months after primary vaccination based on measurements at weeks 0, 1, 2, 4, 6, 7, 8, 10, and 24..

Longitudinal rabies virus neutralizing antibody (RVNA) titers
FROM BASELINE (PRIOR TO PRIMARY VACCINATION) THROUGH 6 MONTHS AFTER PRIMARY VACCINATION BASED ON MEASUREMENTS AT WEEKS 0, 1, 2, 4, 6, 7, 8, 10, AND 24.
Will compare quantitative levels of RVNA (log10 IU/mL) between CAR-T cell therapy and healthy participants at weekly intervals after each vaccination and at 6 months after primary vaccination.
FROM BASELINE (PRIOR TO PRIMARY VACCINATION) THROUGH 6 MONTHS AFTER PRIMARY VACCINATION BASED ON MEASUREMENTS AT WEEKS 0, 1, 2, 4, 6, 7, 8, 10, AND 24.
Proportion of participants with sustained vaccine response
6 MONTHS AFTER THE PRIMARY VACCINATION
This will be defined as a rabies virus neutralizing antibody (RVNA) titer ≥0.5 IU/ml at 6 months following the primary vaccination in participants who also receive secondary vaccination per-protocol
6 MONTHS AFTER THE PRIMARY VACCINATION
Longitudinal rabies virus binding IgG antibody titers
FROM BASELINE (PRIOR TO PRIMARY VACCINATION) THROUGH 6 MONTHS AFTER PRIMARY VACCINATION BASED ON MEASUREMENTS AT WEEKS 0, 1, 2, 4, 6, 7, 8, 10, AND 24.
Will compare quantitative levels of anti-rabies virus IgG between CAR-T cell therapy and healthy participants at weekly intervals after each vaccination and at 6 months after primary vaccination.
FROM BASELINE (PRIOR TO PRIMARY VACCINATION) THROUGH 6 MONTHS AFTER PRIMARY VACCINATION BASED ON MEASUREMENTS AT WEEKS 0, 1, 2, 4, 6, 7, 8, 10, AND 24.
Longitudinal rabies virus binding IgM antibody titers
FROM BASELINE (PRIOR TO PRIMARY VACCINATION) THROUGH 6 MONTHS AFTER PRIMARY VACCINATION BASED ON MEASUREMENTS AT WEEKS 0, 1, 2, 4, 6, 7, 8, 10, AND 24.
Will compare quantitative levels of anti-rabies virus IgM between CAR-T cell therapy and healthy participants at weekly intervals after each vaccination and at 6 months after primary vaccination.
FROM BASELINE (PRIOR TO PRIMARY VACCINATION) THROUGH 6 MONTHS AFTER PRIMARY VACCINATION BASED ON MEASUREMENTS AT WEEKS 0, 1, 2, 4, 6, 7, 8, 10, AND 24.
Proportion of participants with positive vaccine response
4 WEEKS AFTER THE SECONDARY VACCINATION
This will be defined as a rabies virus neutralizing antibody (RVNA) titer ≥0.5 IU/ml at week 4 post-secondary immunization. This RVNA titer is considered to be evidence of an adequate immune response by the World Health Organization.
4 WEEKS AFTER THE SECONDARY VACCINATION

Patient Q & A Section

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

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

Overall, 8,903 lymphomas were diagnosed in the 3-year period, making neoplasms of the B-cell lineage the second most common in the study population. Median age at diagnosis was 74 years, and there were more diagnoses in whites (72%) than in blacks (61%); however, the differences were not statistically significant. In contrast, the median age at diagnosis for individuals with Hodgkin's disease was 34 years, and was significantly higher in whites than in Blacks (P = 0.01). For patients with lymphoma, the incidence of age >or= 70 years was highest among black populations in the states of Tennessee, Virginia, and West Virginia.

Anonymous Patient Answer

What are common treatments for lymphoma, b-cell?

Treatment for lymphomas is dependent upon the specific type of cancer, how far along and how fast the cancer has progressed. Common treatments include surgery, chemotherapy, and radiotherapy. More specifically, treatment involves the use of steroids in chronic cases to eliminate the production of white blood cells. When it comes to lymphomas of the skin, which have a greater likelihood of recurrence, more often the cancer is subjected to surgical removal. In the most severe cases, chemotherapy may be required. When treatment is provided for lymphoma, there is no cure. theme:

This presentation was first presented in 2006.

Anonymous Patient Answer

What are the signs of lymphoma, b-cell?

Lymphoma, b-cell manifests as non-painful lymph nodes that are not palpable. Non-painful swelling in the neck, groin, or around the genitals can all be signs of lymphoma, b-cell. Lymph node biopsies may be abnormal without B-cells present. If a pathologist confirms lymphoma, it is a B-cell lymphoma.

Anonymous Patient Answer

Can lymphoma, b-cell be cured?

Lymphoma, b-cell is highly curable. However, as a result of a high initial rate of progressive disease, the disease may ultimately be untreatable. The exact incidence of cure varies geographically. For example, in Europe, 60-70% of stage III and IV lymphomas are curable when diagnosed early at stages B and T. However, these rates of cure dramatically drop to only 10% when advanced disease is identified.

Anonymous Patient Answer

What causes lymphoma, b-cell?

The most likely explanation for the B-cell lymphoma incidence is that there has been a gradual rise in exposure to this cancer type, but there is no evidence that exposure to ionizing radiation was responsible for this rise in incidence. In fact, [immunotherapy treatment for lymphoma, B-cell (Chediak Higashi Syndrome) that shrinks tumors in only about 1 or 2 out of 10 patients] that might indicate that [immunotherapy treatment probably (Chediak Higashi Syndrome) could be one of the causes for lymphoma, B-cell in rare instances (http://www.medlineplus.com#ibc) but certainly not the cause(s).

Anonymous Patient Answer

What is lymphoma, b-cell?

Lymphoma, b-cell is a type of cancer that attacks the lymphatic system and includes the lymph nodes. It is more common in young people and in people of African descent. Most lymphomas are of B-cell origin and are related to infection with the Epstein-Barr virus.

Anonymous Patient Answer

What are the chances of developing lymphoma, b-cell?

Immunosuppression is one of the risk factors for developing lymphoma. This risk is much higher in patients with B-cell lymphoma. An increasing number of patients with B-cell lymphoma had no prior history of B-cell disease, which can contribute towards diagnosis of these cases.

Anonymous Patient Answer

How serious can lymphoma, b-cell be?

lymphomas, b-cell have high rates of local, distant or both recurrence and/or refractoriness after autologous stem cell transplantation. Long-term survival is poor regardless of treatment modality and is adversely influenced by grade of lymphoma, extranodal sites, number of involved lymph nodes and high systemic IPI score. Lymphoma, b-cell treatment should reflect this poor long-term outcome and be targeted to high-risk patients or in specific subsets.

Anonymous Patient Answer

Does lymphoma, b-cell run in families?

Findings from a recent study failed to provide any evidence that B-NIPA has an autosomal dominant mode of inheritance. Lymphoma of B cells is a heterogeneous disease that is not a hereditary disease.

Anonymous Patient Answer

How quickly does lymphoma, b-cell spread?

The incidence of B-cell lymphoma increased from 0.9 to 2.6 per million person-years from 1990 to 2002. At that time, there was no difference in the incidence of lymphoma between urban and rural areas. This might be because people living in cities can receive health care sooner. In addition, the majority of people living at a high altitude (3300 feet) have been reported to develop B-cell lymphoma. It is expected that the incidence of B-cell lymphoma will increase in Tibet, China, as the population increases and people live in increasingly crowded and overcrowded areas.

Anonymous Patient Answer

What is biospecimen collection?

Collecting bone marrow and blood for diagnosis/monitoring of tumors or infectious diseases in an oncology clinic setting is a specialized task with a limited number of experts or clinicians trained in it. A common recommendation is that samples only be collected when appropriate and at the time of enrollment of patients, and be preserved for at least 1 month, for possible research use. Appropriate biospecimen collection involves a detailed discussion about the role of these samples, and their use with the patient.

Anonymous Patient Answer

What is the survival rate for lymphoma, b-cell?

Approximately 10% (1,100 patients) of lymphoma had a five-year survival rate of 79%-99% of patients, and 2% (45 patients) had a five-year survival of 1-99% (median 48%).

Anonymous Patient Answer
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