CLINICAL TRIAL

Lenalidomide for Lymphoma, Large B-Cell, Diffuse

Recruiting · 18+ · All Sexes · Busan, Korea, Republic of

Brentuximab Vedotin Plus Lenalidomide and Rituximab for the Treatment of Relapsed/Refractory DLBCL

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About the trial for Lymphoma, Large B-Cell, Diffuse

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

Treatment Groups

This trial involves 2 different treatments. Lenalidomide is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Rituximab
DRUG
Brentuximab vedotin
DRUG
Lenalidomide
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Rituximab
DRUG
Lenalidomide
DRUG
Placebo
OTHER

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
FDA approved
Brentuximab vedotin
FDA approved
Lenalidomide
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Lymphoma, Large B-Cell, Diffuse or one of the other 3 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:
You have one or more co-morbidities that make you medically unfit to receive HSCT or CAR-T therapy. show original
Participants with relapsed or refractory diffuse and transformed large B-cell lymphoma (R/R DLBCL). DLBCL and cell of origin (GCB versus non-GCB) will be histologically determined by local pathology assessment for the purposes of study eligibility and stratification.
Participants must have R/R disease following 2 or more lines of prior systemic therapy. show original
You have received systemic therapy for DLBCL. show original
You have active disease following induction and salvage chemotherapy. show original
Inadequate stem cell mobilization (for HSCT)
You have had a previous HSCT or CAR-T. show original
Unable to receive CAR-T therapy due to financial, geographic, insurance, or manufacturing issues
Participants must have tumor tissue submitted to the central pathology lab. The tumor tissue submitted should be from the most recent biopsy that contains DLBCL.
You have a performance status score of 0 to 2. 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: Approximately 1 year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Approximately 1 year.
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 Lenalidomide will improve 3 primary outcomes and 6 secondary outcomes in patients with Lymphoma, Large B-Cell, Diffuse. Measurement will happen over the course of Approximately 18 months.

Overall survival (OS) in the ITT population
APPROXIMATELY 18 MONTHS
Time from the date of randomization to date of death due to any cause.
OS in the CD30+ population
APPROXIMATELY 18 MONTHS
Time from the date of randomization to date of death due to any cause.
Duration of objective response
APPROXIMATELY 1 YEAR
Time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression (Cheson 2014) or death due to any cause, whichever comes first.
Complete response (CR) rate
APPROXIMATELY 1 YEAR
Proportion of participants with CR according to the Lugano Criteria for Response Assessment (Cheson 2014)
PFS per BICR in the CD30-positive population
APPROXIMATELY 1 YEAR
Time from the date of randomization to the date of first documentation of PD per BICR or to death due to any cause, whichever occurs first.
PFS per blinded independent central review (BICR) in the ITT population
APPROXIMATELY 1 YEAR
Time from the date of randomization to the date of first documentation of PD per BICR or to death due to any cause, whichever occurs first.
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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.

Can lymphoma, large b-cell, diffuse be cured?

Cured lymphoma often occurs in both patients undergoing HD and patients receiving RFA. However, not everyone with curable lymphoma survives longer than a typical 5-year life span.

Anonymous Patient Answer

What is lymphoma, large b-cell, diffuse?

LLD is the most common type of large B-cell lymphoma and is almost invariably fatal. LLD is a progressive disease that usually presents with enlarged lymph nodes and/or extensible (i.e., ulcerated) lesions, although it is also associated with signs and symptoms of a more aggressive disease.

Anonymous Patient Answer

What are the signs of lymphoma, large b-cell, diffuse?

A person with large cell lymphoma has a multitude of symptoms. Typically, small-cell lymphoma leads to systemic symptoms while large-cell lymphoma is the predominant cause of symptoms in a small subset.\n\n- List of medical signs\n- Medical sign"

"Pachycladaceae\n\nThe Pachycladaceae are a family of ferns in the Dryopteridales described as a family in 1825. The family is accepted in the Pteridophyte Phylogeny Group classification of 2016 (PPG I) but not by some other classifications.

Anonymous Patient Answer

What causes lymphoma, large b-cell, diffuse?

Lymphoma, large b-cell, diffuse arises as a monomorphic lesion through the successive steps of centripetal tissue replacement. Large B-cell diffuse arises as an aggressive tumor with infiltrative growth, indicating the necessity of surgery for early stages.

Anonymous Patient Answer

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

Patients are being diagnosed with DLBD at a younger age than the general population. As DLBD continues to be considered a form of chronic lymphocytic leukemia rather than a non-Hodgkin lymphoma, the number of patients receiving treatment in the United States would likely reach more than 60% of the population as a whole unless the disease has a much slower cumulative risk.

Anonymous Patient Answer

What are common treatments for lymphoma, large b-cell, diffuse?

Treatment of lymphoma is challenging and highly reliant on the complexity of the disease and patient characteristics. Novel chemotherapy regimes such as Rituximab plus CHOP are being phased in for newly diagnosed aggressive B-cell LLD patients and are effective but very difficult to implement in resource-constrained settings for advanced/refractory forms of lymphoma.

Anonymous Patient Answer

How does lenalidomide work?

Lenalidomide exerts its direct antitumor action by increasing apoptosis, via upregulation the Bax/Bcl-2/Bcl-xl ratios, and decreasing the nuclear factor-kappaB (NF-kappaB) pro-apoptotic activity with little effect on apoptosis in other myeloma cells and in normal immune cells.

Anonymous Patient Answer

How serious can lymphoma, large b-cell, diffuse be?

The data collected by the authors of this paper indicate that the prognosis for diffuse large B cell lymphoma is dependent not only on the histology of the malignant neoplasm but also on the extent of disease at the time of diagnosis. The authors feel that it may be prudent to recommend the addition of cytochemotherapy to conservative therapy in the early stages of large cell diffuse non-Hodgkin lymphoma, since it tends to produce a higher, more homogenous rate of remission than conservative therapy alone.

Anonymous Patient Answer

Have there been other clinical trials involving lenalidomide?

This trial shows feasibility of using lenalidomide as a second-line option for patients with relapsed/refractory CLL who have not responded adequately to rituximab. A larger phase III trial using these subjects is warranted.

Anonymous Patient Answer

What is the average age someone gets lymphoma, large b-cell, diffuse?

Age at diagnosis of lymphoma was 55 years/male and 51 years/female for large B-cell lymphoma, diffuse. Age at diagnosis of lymphoma was 64 years/male and 52 years/female for T-cell lymphomas.

Anonymous Patient Answer

What is the primary cause of lymphoma, large b-cell, diffuse?

The study did not find any evidence of an association between HLA-C-mismatch and the development of DLBCL, regardless of the type of chemotherapy used in a patient's regimen. Overall, the incidence of DLBCL in patients who had HLA-C-mismatch was not significantly different from patients without HLA-C-mismatch.

Anonymous Patient Answer

Does lenalidomide improve quality of life for those with lymphoma, large b-cell, diffuse?

Lenalidomide provided a significant (p<0.05) increase in quality of life compared to observation alone and is currently the only agent to show a substantial improvement in quality of life after one cycle of treatment.

Anonymous Patient Answer
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