CLINICAL TRIAL

ibrutinib for Lymphoma

Waitlist Available · 18+ · All Sexes · Lake Forest, IL

This study is evaluating whether a drug called ibrutinib can be given to patients with mantle cell lymphoma (MCL) as maintenance therapy after induction chemotherapy.

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About the trial for Lymphoma

Eligible Conditions
Stage III Mantle Cell Lymphoma · Noncontiguous Stage II Mantle Cell Lymphoma · Stage II Contiguous Mantle Cell Lymphoma · Lymphoma, Mantle-Cell · Lymphoma · Stage IV Mantle Cell Lymphoma · Stage I Mantle Cell Lymphoma

Treatment Groups

This trial involves 2 different treatments. Ibrutinib 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 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.
ibrutinib
DRUG
laboratory biomarker analysis
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
Ibrutinib
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:
on or after the last day of induction chemotherapy show original
or chemotherapy Radiotherapy and chemotherapy may have been previously received by patients. show original
Patients must be at least 14 days out from their last dose of cytotoxic chemotherapy, but no more than 90 days show original
and provide written informed consent Patients must have an Eastern Cooperative Oncology Group performance status of less than or equal to 2 and must provide written consent. show original
Please note: Measurable disease is not required, but will be followed if it exists
Patients who received combinations of the above regimens are not eligible for enrollment
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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: 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 ibrutinib will improve 1 primary outcome, 3 secondary outcomes, and 1 other outcome in patients with Lymphoma. Measurement will happen over the course of Four time-points: baseline (pre-treatment), after 1 month and 6 months of treatment, and approximately 18-24 months post-first dose of treatment.

Compare Minimum Residual Disease (MRD) results overtime by Polymerase Chain Reaction (PCR) and correlate these with PFS and OS
FOUR TIME-POINTS: BASELINE (PRE-TREATMENT), AFTER 1 MONTH AND 6 MONTHS OF TREATMENT, AND APPROXIMATELY 18-24 MONTHS POST-FIRST DOSE OF TREATMENT
Archived tissue from a previous biopsy from all patients will be obtained for baseline clone identification; in addition, peripheral whole blood samples will be collected at four time points. MRD analysis will be conducted using PCR methods and results will be compared over time and correlated with PFS and OS.
Incidence of adverse events, defined according to the National Cancer Institute's Common Terminology Criteria for Adverse Events version 4.0
UP TO 30 DAYS AFTER COMPLETION OF STUDY TREATMENT, MAXIMUM 4 YEARS POST-FIRST DOSE
To assess toxicity, all adverse events will be summarized as to type, severity, frequency, timing and attribution.
Determine the progression-free survival (PFS) rate after 2 years
ASSESSED AT 2 YEARS
PFS will be measured from start of treatment to time of progression. Evidence of clinical progression will be documented by imaging (CT scan) for patients who have measurable disease.
Determine median Overall Survival (OS) after 4 years
UP TO 4 YEARS POST-FIRST DOSE
Patients will be evaluated monthly for the first 6 months on treatment, then every 3 months thereafter. Patients who go off treatment will continue to be followed for up to 4 years post-first dose. Follow-up will occur every 3 months (up to 2 years after the first dose of treatment) and then every 6 months thereafter (up to 4 years post-first dose). Median OS after 4 years will be calculated.
Rate of conversion from Partial Response (PR) to Complete Response (CR)
UP TO 4 YEARS
Progression will be evaluated using Cheson 2007 criteria, only patients who had a PR at the time of registration and who complete ≥ 1 complete cycle of ibrutinib maintenance therapy will be evaluable for this endpoint.

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 causes lymphoma?

The most common form of lymphoma is diffuse large B-cell lymphoma, which may be related to an environmental exposure such as exposure to cigarette smoke. This is because cigarette smoking increases the risk of developing other types of lymphoma. The risk of developing lymphoma rises with the number of cigarettes smoked and with increasing age, especially for stomach/intestinal-type lymphoma.

Anonymous Patient Answer

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

The American Cancer Society estimates that 30,600 cases of Hodgkin disease and 18,400 cases of non-Hodgkin's lymphoma will be diagnosed in the United States in 2017. The most common form of lymphoma is diffuse large B cell lymphoma. Other forms of NHL include anaplastic large cell lymphoma and mantle cell lymphoma.\n

Anonymous Patient Answer

Can lymphoma be cured?

The most common (and curable) form of lymphoma is diffuse large B-cell lymphoma (50%), which tends to have better outcomes than most other lymphomas, as measured by the five-year relative survival rate (65% relative survival, compared to less than 20% for Burkitt's and Burkitt-like lymphomas). The prognosis for follicular lymphoma is poor. The remaining lymphomas are more difficult to treat, but some of these - particularly non-Hodgkin's lymphomas and (somewhat more) poor prognosis non-Hodgkin's lymphomas - can be cured, and long-term survivals have been achievable.

Anonymous Patient Answer

What are common treatments for lymphoma?

Treatments may be varied depending on severity, stage of disease, and comorbidity. When possible, chemotherapy is normally the treatment of choice for early stage disease. It can be combined with radiotherapy to increase the overall effectiveness and control of the disease. As chemotherapy and radiation are effective for most cases of lymphoma, most treatments are tailored towards each case's individual needs. Radiation is often used when patients present with recurrent disease to address symptoms or minimize recurrence, including local symptoms from a second tumour. Lymphomas are radiosensitive and may respond to radiation and chemotherapy to a satisfactory degree.

Anonymous Patient Answer

What are the signs of lymphoma?

There is a wide variety in the signs of peripheral Non-Hodgkin’s lymphoma and non-malignant disorders. However, the combination of symptoms can help diagnose the exact pathology.

Anonymous Patient Answer

What is lymphoma?

Although lymphoma is also an orphan disease it was not a part of this study. Most of the patients were older males, the median age of diagnosis was 73 years. Lymphoma was associated with a variety of clinical features, many of which were age related.

Anonymous Patient Answer

How quickly does lymphoma spread?

In our series, the most frequent sites for lymphoma metastases were lungs and liver, whereas other parts of the body are only rarely involved. We also found that lymphoma seems to diffuse from site to site more slowly than reported in other studies. Lymphoma seems to spread more slowly than, but similar as, most other malignancies if there are no clinical signs of a very high lymphoma burden.

Anonymous Patient Answer

What is the average age someone gets lymphoma?

Most lymphomas are detected in people aged 60 to 69 years, even though most lymphomas occur in adults, and younger people get a much higher proportion of T- and B-cell lymphomas. The most common lymphoma is follicular lymphoma. The mean age at diagnosis is 63 years for cutaneous T-cell lymphomas. It is imperative that lymphoid diseases in the elderly are recognized early to ensure that good-enough treatment is offered and that they receive it early enough to increase their chances of survival to their full potential.

Anonymous Patient Answer

Who should consider clinical trials for lymphoma?

The vast majority of trial-eligible patients die before the completion of a trial, so the data from those patients have little bearing in decisions about treatment in the community. The study does give some useful insights into patient characteristics. Results from a recent clinical trial of clinical trials are generally more relevant to care in the community than to patient characteristics. If all the available data were pooled, the study would show similar patterns when considering many of the other treatments available in Canada at the time of the database’s completion. Most clinical trials were not designed to evaluate patient characteristics; therefore, the results of the Loyola Study of the 1980s are interesting because data from that study do not show differences in survival among subtypes with respect to specific patient characteristics.

Anonymous Patient Answer

Have there been other clinical trials involving ibrutinib?

Recent findings of this trial add to the body of evidence supporting the activity of ibrutinib in patients with relapsed or refractory rituximab- or bortezomib-resistant mantle cell Lymphoma and warrants further clinical investigation of ibrutinib for treatment of ibrutinib-refractory disease.

Anonymous Patient Answer

How serious can lymphoma be?

It is important in determining prognosis and future therapeutic decisions for patients with aggressive lymphoma that we possess the following criteria: A. A score of > 10 on the Memorial Sloan-Kettering Cancer Institute's pre-treatment Lymphoma Staging Score on a 10 point scale based on Burden of disease: Presence or absence of extranodal tissue involvement; presence of visceral/vascular involvement and/or organ involvement; presence of distant involvement or bone marrow involvement\nB. Presence of advanced disease and/or symptomatic cancer-related symptoms; B.

Anonymous Patient Answer

Does lymphoma run in families?

It is clear that lymphoma runs in families as shown by the recurrences over several generations. The exact cause(s) is unknown, but this knowledge may provide a basis for understanding the risk factors that may influence prevention of lymphoma, and may help to refine the use of chemotherapy. The fact that only one of the families with 2 confirmed cases occurred in an ethnic group with higher than normal incidence should prompt one to look at genetic variants which might predispose to this specific type of lymphoma. The implication is that other ethnic groups may have a distinct genetic profile in terms of lymphoma risk, and that genetic variants associated with lymphoma risk would be identifiable. This information might assist in risk-adaptation.

Anonymous Patient Answer
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