CLINICAL TRIAL

Pneumococcal 13-valent Conjugate Vaccine for Lymphoma, Diffuse

Refractory
Recruiting · 18+ · All Sexes · Rochester, MN

This study is evaluating whether a combination of dendritic cell therapy, cryosurgery and pembrolizumab may be more effective than dendritic cell therapy, cryosurgery or pembrolizumab alone in treating patients with non-Hodgkin lymphoma

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About the trial for Lymphoma, Diffuse

Eligible Conditions
Lymphoma, Non-Hodgkin · Lymphoma, Mantle-Cell · Lymphoma, B-Cell · Indolent Non Hodgkin's Lymphoma (iNHL) · Recurrent Follicular Lymphoma · Recurrent Diffuse Large B-Cell Lymphoma · Lymphoma, Large B-Cell, Diffuse · Lymphoma · Recurrent Mantle Cell Lymphoma · Recurrent Marginal Zone Lymphoma · Recurrent Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma · Lymphoma, T-Cell · Leukemia, Lymphocytic, Chronic, B-Cell · Small Lymphocytic Lymphoma · Aggressive Non-hodgkin Lymphoma (aNHL) · Recurrent Non-Hodgkin Lymphoma · Recurrent T-Cell Non-Hodgkin Lymphoma

Treatment Groups

This trial involves 2 different treatments. Pneumococcal 13-valent Conjugate Vaccine 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 & 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.
Cryosurgery
PROCEDURE
Pneumococcal 13-valent Conjugate Vaccine
BIOLOGICAL
Dendritic Cell Therapy
BIOLOGICAL
Pembrolizumab
BIOLOGICAL
Laboratory Biomarker Analysis
OTHER
Quality-of-Life Assessment
OTHER
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
Cryosurgery
2015
Completed Phase 4
~480
Streptococcus pneumoniae type 18c capsular polysaccharide antigen
FDA approved
Pembrolizumab
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:
Histological confirmation of biopsy-proven non-Hodgkin lymphoma, excluding chronic lymphocytic leukemia, primary central nervous system (CNS) lymphoma and Burkitt's lymphoma; Note: small lymphocytic lymphoma (SLL) is allowed
Age >= 18 years
Patients with indolent non-Hodgkin lymphoma (NHL) must have had >= 1 regimen of rituximab-containing regimen; Note: this includes follicular lymphoma (FL), marginal lymphoma and mucosa-associated lymphoid tissue (MALT)
Patients with aggressive NHL must have had >= 2 regimens; Note: This includes diffuse large B cell lymphoma (DLBCL), mantle cell lymphoma (MCL), primary mediastinal large B-cell lymphoma (PMBCL), and T cell lymphoma
Anti-CD20 monoclonal antibody unless tumor is CD20 negative
An anthracycline containing regimen
Transformed FL must have had therapy for FL and be refractory to chemotherapy for DLBCL
Stable disease of =< 12 months or progressive disease as best response to most recent chemotherapy containing regimen
Disease progression or recurrence =< 12 months of prior autologous stem cell transplantation (SCT)
Patients with aggressive NHL must have failed autologous hematopoietic stem cell transplantation (HSCT), or are ineligible or not consenting to autologous HSCT
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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

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 4 years
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 4 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 4 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 Pneumococcal 13-valent Conjugate Vaccine will improve 2 primary outcomes, 8 secondary outcomes, and 2 other outcomes in patients with Lymphoma, Diffuse. Measurement will happen over the course of From registration to death due to any cause, assessed up to 2 years.

Overall survival
FROM REGISTRATION TO DEATH DUE TO ANY CAUSE, ASSESSED UP TO 2 YEARS
The distribution of survival time will be estimated using the method of Kaplan-Meier.
FROM REGISTRATION TO DEATH DUE TO ANY CAUSE, ASSESSED UP TO 2 YEARS
Disease free survival rate
AT 2 YEARS
AT 2 YEARS
Treatment free survival
FROM REGISTRATION TO NEXT TREATMENT OR DEATH DUE TO ANY CAUSE, ASSESSED UP TO 4 YEARS
The distribution of treatment-free survival will be estimated using the method of Kaplan-Meier.
FROM REGISTRATION TO NEXT TREATMENT OR DEATH DUE TO ANY CAUSE, ASSESSED UP TO 4 YEARS
Change in immunologic correlates
BASELINE UP TO 4 YEARS
Will be evaluated and summarized both quantitatively and graphically. Each of the correlative endpoints will be summarized individually, but will also be evaluated in terms of their relationships to one another; i.e., will use Spearman rank correlation coefficient to assess the correlations between baseline levels as well as between changes before and after treatment in these immunologic markers. In addition, these immunologic markers will be correlated with cancer and treatment- related outcomes (e.g. response, toxicities). Relationships will also be explored graphically using scatter plots.
BASELINE UP TO 4 YEARS
Complete response
UP TO 4 YEARS
The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated. The response rate will be calculated, in each individual cohort as supplementary.
UP TO 4 YEARS
Duration of response
UP TO 4 YEARS
The distribution of duration of complete response will be estimated using the method of Kaplan-Meier.
UP TO 4 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.

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

Lymphoma, diffuse is the most common type of lymphoma seen in autopsy specimens in the United States, although cases of diffuse lymphomas of other types, such as follicular lymphomas, SLLs, and mantle-cell lymphomas, are likely to be under-reported.

Anonymous Patient Answer

What are common treatments for lymphoma, diffuse?

Treatment for lymphoma, diffuse commonly includes chemotherapy (95% of patients), radiotherapy (89%) and other treatment with steroids (87%). There are very limited therapies available for lymphoma, diffuse to reduce symptoms and to improve survival.

Anonymous Patient Answer

What causes lymphoma, diffuse?

The most accurate prediction of death in the long term for patients with NHL and DLBCL is based on a three-combination model incorporating the presence of B symptoms at diagnosis, the stage at diagnosis, and serum lactate dehydrogenase levels at diagnosis. Survival is significantly influenced by the presence of B symptoms.

Anonymous Patient Answer

What is lymphoma, diffuse?

There is no evidence of benefit in diffuse lymphoma patients with a first-line treatment of rituximab in combination with high-dose chemotherapy. There is no evidence of benefit for chemotherapy in patients with a first-line treatment of rituximab. There is no evidence of benefit of radiotherapy in combination with high-dose chemotherapy. Overall, there was no statistically significant impact.

Anonymous Patient Answer

Can lymphoma, diffuse be cured?

Recent findings shows for the first time in the literature that in some subtypes of diffuse large B cell lymphomas a complete remission can be obtained, implying that in rare cases a potential cure is possible. The prognosis of this type of cancer is poor, since patients often relapse and succumb quickly to aggressive relapse. Patients with DLBCL, diffuse must therefore be evaluated aggressively and early, to obtain better chances of complete remission. Treatment options, which are in general currently considered effective for other B cell lymphomas, may need to be modified to attain the desired outcome for DLBCL diffuse.

Anonymous Patient Answer

What are the signs of lymphoma, diffuse?

Lymphoma diffuse is most commonly associated with: a swollen neck (83%) and/or adenopathy, enlarged liver (83%), and/or enlarged spleen (50%), enlarged bone or other sites (44%), and/or anemia (32%); (36% of patients had none of these signs); and a palpable spleen or enlarged kidney (34%). The lymphoma diffuse is most commonly associated with: a non-B\nl lymphoma (75%).

Anonymous Patient Answer

How serious can lymphoma, diffuse be?

The case presented illustrates that patients with lymphoma, diffuse type may present with unusual medical and surgical manifestations in addition to their usual cancer symptoms. Lymphoma, diffuse type, like lymphoma, follicular, is a highly aggressive disease, and this patient had a very poor prognosis despite receiving chemotherapy and hematological remission. It is possible the aggressive nature of the lymphoma, diffuse type, diffuse lymphoma, was the cause of these presentations. Finally, this case demonstrates that more aggressive diagnostic and clinical assessments prior to beginning treatment are necessary to allow for appropriate treatment.

Anonymous Patient Answer

What is the survival rate for lymphoma, diffuse?

Diffuse large B-Cell lymphoma (DLBCL), which is the most common type of lymphoma, is found in approximately one in ten individuals who are diagnosed with a malignancy. The survival rate for DLBCL is 60 percent.

Anonymous Patient Answer

Have there been any new discoveries for treating lymphoma, diffuse?

Only 2 case series have been found in the literature since 1990 concerning treatment options for diffuse lymphoma, and their results have shown no significant difference in treatment protocols. As such, it is recommended that all lymphoma, diffuse be included in future meta-analyses of treatment research, since it remains, for example, the most common form of lymphoma. Clinically, however, there are no more treatments for this form of lymphoma, unless the patient is eligible to participate in clinical trials. Please use the [Power(https://www.withpower.com/d/lymphoma-diffuse-tract) site to find out if you would be appropriate for one of these clinical trials.

Anonymous Patient Answer

What is the primary cause of lymphoma, diffuse?

These data suggest that the primary cause of diffuse NHL is not due to infection with EBV or HLV, as previously suggested. Rather, it may be an autoimmune disorder occurring as a side effect of other autoimmunities.

Anonymous Patient Answer

What are the latest developments in pneumococcal 13-valent conjugate vaccine for therapeutic use?

Vaccine induced potent protective immunity as seen in vaccinated children was not seen in the non-vaccinated individuals. In a large group of young children vaccinated with PCV13 a high rate of serious complications and death was also observed at a rate statistically higher than in non vaccinated group. There were no serious adverse events in this study which had been reported in a number of earlier studies. PCV13 is safe and effective for the treatment of uncomplicated childhood pneumonia in high burden settings.

Anonymous Patient Answer

Does lymphoma, diffuse run in families?

Results from a recent clinical trial suggested that lymphoma, diffuse, run in families is more common than generally reported. Considering the possible high incidence of lymphoma, we suggest close follow-up in family members with lymphoma, especially those aged >50 years.

Anonymous Patient Answer
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