CLINICAL TRIAL

Ibrutinib for Lymphoma, Large B-Cell, Diffuse

High Risk
Metastatic
Newly Diagnosed
Waitlist Available · 18+ · All Sexes · Houston, TX

This study is evaluating whether a combination of rituximab, lenalidomide, and ibrutinib with chemotherapy works in treating patients with high-risk diffuse large B-cell lymphoma.

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

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

Treatment Groups

This trial involves 2 different treatments. Ibrutinib is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
Prednisone
DRUG
+
Rituximab
BIOLOGICAL
+
Cyclophosphamide
DRUG
+
Doxorubicin Hydrochloride
DRUG
+
Lenalidomide
DRUG
+
Ibrutinib
DRUG
+
Vincristine Sulfate
DRUG
Experimental Group 2
Prednisone
DRUG
+
Rituximab
BIOLOGICAL
+
Cyclophosphamide
DRUG
+
Doxorubicin Hydrochloride
DRUG
+
Lenalidomide
DRUG
+
Etoposide
DRUG
+
Ibrutinib
DRUG
+
Vincristine Sulfate
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methylprednisolone
FDA approved
Rituximab
FDA approved
Cyclophosphamide
FDA approved
Doxorubicin
FDA approved
Lenalidomide
FDA approved
Beta-D-Glucose
Not yet FDA approved
Ibrutinib
FDA approved
Sulfate ion
Not yet FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed 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:
Patients must have bi-dimensional measurable disease, as defined as radiographically apparent disease with the longest dimension of >= 1.5 cm
Patients with performance status of =< 3 (3 only allowed if decline in status is deemed related to lymphoma and felt potentially reversible by the treating physician)
Serum bilirubin < 1.5 x upper limit of normal (ULN) except in patients with Gilbert's syndrome as defined by > 80% unconjugated bilirubin
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x ULN or < 5 x ULN if hepatic metastases are present
Absolute neutrophil count (ANC) > 1000/mm^3 unless deemed related to lymphoma involvement in the bone marrow and felt potentially reversible by the treating physician
Histopathologically confirmed diagnosis of previously untreated DLBCL of the non-GCB DLBCL subtype
No prior treatment except a prior limited-field radiotherapy, a short course of glucocorticoids =< 25 mg daily of prednisone equivalent which must cease prior to day 1 of cycle 1, and/or cyclophosphamide for an urgent lymphoma related problem at diagnosis (e.g. epidural cord compression, superior vena cava syndrome)
Patient or durable power of attorney (DPA) for healthcare must be able to understand and voluntarily sign an Institutional Review Board (IRB) -approved informed consent form
Platelets > 100,000/mm^3 unless deemed related to lymphoma involvement in the bone marrow and felt potentially reversible by the treating physician
Calculated creatinine clearance >=30 ml/min by Cockcroft-Gault formula
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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: 1 year
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 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 Ibrutinib will improve 1 primary outcome and 5 secondary outcomes in patients with Lymphoma, Large B-Cell, Diffuse. Measurement will happen over the course of Up to 6 weeks (2 cycles).

Overall response rate of rituximab, lenalidomide and ibrutinib alone defined as complete response or partial response
UP TO 6 WEEKS (2 CYCLES)
Overall response rate will be measured using Bayesian method.
UP TO 6 WEEKS (2 CYCLES)
Incidence of adverse events
UP TO 1 YEAR
Toxicities will be summarized by grade and by their relationship to treatment.
UP TO 1 YEAR
Complete response rate
AT 1 YEAR
Complete response of rituximab, lenalidomide and ibrutinib with chemotherapy (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate and prednisone or etoposide, prednisone, vincristine sulfate, cyclophosphamide, doxorubicin hydrochloride rate will be measured using Bayesian method. Will be summarized by frequency and 95% confidence interval.
AT 1 YEAR
Overall survival rate
1 YEAR
Will be summarized by frequency and 95% confidence interval. The distribution of time-to-event endpoints will be estimated by Kaplan-Meier estimate. Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test. Cox proportional hazards regression will be employed for multivariate analysis on time-to-event outcomes.
1 YEAR
Progression free survival rate
1 YEAR
Will be summarized by frequency and 95% confidence interval. The distribution of time-to-event endpoints will be estimated by Kaplan-Meier estimate. Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test. Cox proportional hazards regression will be employed for multivariate analysis on time-to-event outcomes.
1 YEAR
Overall response rate at end of treatment in patients with adult diffuse large B-cell lymphoma
1 YEAR
Overall response rate will be measured using the Bayesian method.
1 YEAR

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, large b-cell, diffuse?

In the Western population, large b-cell lymphoma, diffuse is the most common subtype of primary high-grade B-cell lymphoma diagnosed in the USA. Although aggressive therapy has the potential to improve the outcome of large B-cell lymphoma, the disease-free survival in Western populations has generally poor outcomes.

Anonymous Patient Answer

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

Most commonly seen signs of lymphoma, large B-Cell, diffuse include enlarged lymph nodes, bulky disease, anemia, hepatosplenomegaly, enlarged spleen or liver, and a low white blood cell count. The severity of these signs determines the likelihood of aggressive lymphoma.

Anonymous Patient Answer

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

Patients are often treated with a combination of anti-cancer drugs and radiation therapy. This helps to eliminate all traces of cancer cells before radical surgery. The prognosis for aggressive, newly diagnosed cases is excellent. Survival remains high, with overall five-year survival rates close to 100% in countries where chemotherapy is used as a standard of care. However, in countries where chemotherapy is not provided routinely, these values are significantly lower and 5-year survival rates at the time of diagnosis can drop to 65% or less over the first 2 years.

Anonymous Patient Answer

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

There was only one L&D in the 1980s. During the last decade there has been a significant increase in L&D. The numbers of diagnoses are likely far higher and will continue to increase. Although a cause is unknown, it remains probable that the increase in L&D has been the result of better diagnostic diagnosis and is likely to become more pronounced in the future.

Anonymous Patient Answer

What causes lymphoma, large b-cell, diffuse?

There are several possible causes of large cell lymphoma, large cell diffuse, including occupational exposure, autoimmune conditions, genetic predisposition, and environmental factors. The disease process may involve a combination of steps, leading first to a neoplastic lymphocyte proliferation and then to cell clonal expansion, invasion, and the growth of disseminated lesions. Lymphoma, large b-cell, diffuse is usually a slowly progressive disease where the overall five year survival rate is more than 70%. Treatments include radiation therapy, chemotherapy, and in some selected cases, surgical resection followed by chemotherapy. We discuss the use of a new chemotherapeutic regimen to eradicate this aggressive disease.

Anonymous Patient Answer

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

Even in rare cases, large diffuse b-cell lymphomas that are refractory to other treatment can achieve long-term survival. The excellent long-term outcome reported in some cases should not be assumed for the vast majority of patients.

Anonymous Patient Answer

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

Lymphoma is a highly varied disease and multiple treatments targeting different aspects of the disease progression may be required for many patients. Currently there are no newly approved treatment options for diffuse large B-cell lymphoma (DLBCL). The use of anti-CD20 antibodies (Rituximab) in combination with CHOP chemotherapy was the most effective treatment reported, although they have been shown to be effective in non-DLBCL patients as well, and in an observational study showed longer survival compared to CHOP alone. A retrospective study suggested that addition of a novel second-line treatment (R-CACOX-Avastin-HDCy-ATG combination therapy) may improve overall survival in patients with DLBCL.

Anonymous Patient Answer

Has ibrutinib proven to be more effective than a placebo?

Ibrutinib was not more effective than a placebo at slowing progression in patients with mantle cell lymphoma and refractory MCL. The clinical benefit, as measured by PFS, has been similar between patients in the ibrutinib and placebo arms. Ibrutinib is a safe, well-tolerated, novel therapy for mantle cell lymphoma, and should be evaluated in combination with previously investigated options.

Anonymous Patient Answer

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

These preliminary findings provide evidence that the addition of ibrutinib to first line of treatment for patients with large B-cell lymphoma, diffuse does not impact overall quality of life. Future large prospective studies are needed to confirm this finding.

Anonymous Patient Answer

Does lymphoma, large b-cell, diffuse run in families?

An excess of lymphoma, large b-cell, diffuse cases and relatives are observed in these families (P = 1 x 10(-7)). This is similar to other reports using this sample set. We suggest further research on the clinical and familial features and a genetic study of these families in order to shed further light on the genetic factors underlying the increased risk of cancer in these cases.

Anonymous Patient Answer

Is ibrutinib typically used in combination with any other treatments?

Ibrutinib is being used in combination therapy in a limited number of other therapeutic situations across diseases from hematological malignancies to non-Hodgkin's lymphomas to autoimmune disorders. Although the use of ibrutinib and its combination with other chemotherapeutics in some situations is growing, it is still typically used in combination therapy only with R-CHOP.

Anonymous Patient Answer

How quickly does lymphoma, large b-cell, diffuse spread?

In the absence of treatment, the median survival is 6 months. The median survival after treatment is 3 months. These data are reassuring considering the limited current treatment options.

Anonymous Patient Answer
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