CLINICAL TRIAL

Lenalidomide for Lymphoma, Follicular

Stage II
Waitlist Available · 18+ · All Sexes · Houston, TX

This study is evaluating whether ibrutinib in combination with rituximab and lenalidomide works better than ibrutinib alone in treating patients with previously untreated, stage II-IV follicular lymphoma or marginal zone

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About the trial for Lymphoma, Follicular

Eligible Conditions
Grade 1 Follicular Lymphoma · Ann Arbor Stage IV Marginal Zone Lymphoma · Grade 2 Follicular Lymphoma · Lymphoma, Follicular · Ann Arbor Stage II Follicular Lymphoma · Lymphoma · Ann Arbor Stage II Marginal Zone Lymphoma · Ann Arbor Stage III Follicular Lymphoma · CD20 Positive · Ann Arbor Stage IV Follicular Lymphoma · Ann Arbor Stage III Marginal Zone Lymphoma · Grade 3a Follicular Lymphoma · Lymphoma, B-Cell, Marginal Zone

Treatment Groups

This trial involves 2 different treatments. Lenalidomide 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
Rituximab
BIOLOGICAL
Lenalidomide
DRUG
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
Rituximab
FDA approved
Lenalidomide
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:
Histologically confirmed CD20+ follicular lymphoma, grade 1, 2, or 3a or marginal zone lymphoma
Platelet counts >= 100,000/mm^3 or >= 50,000/mm^3 if bone marrow involvement with lymphoma, independent of transfusion support in either situation (within 28 days prior to signing informed consent).
Serum aspartate transaminase (AST) or alanine transaminase (ALT) < 3 x upper limit of normal (ULN)
Have had no prior systemic treatment for lymphoma
Bi-dimensionally measurable disease, with at least one mass lesion >= 2 cm in longest diameter by computed tomography (CT), positron emission tomography (PET)/CT, and/or magnetic resonance imaging (MRI)
In the opinion of the investigator would benefit from systemic therapy
Stage II, III, or IV disease
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Absolute neutrophil count (ANC) >= 1,000/mm^3, independent of growth factor support (within 28 days prior to signing informed consent).
Creatinine clearance > 30 ml/min calculated by modified 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: Up to 3 years
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 3 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 3 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 Lenalidomide will improve 1 primary outcome and 7 secondary outcomes in patients with Lymphoma, Follicular. Measurement will happen over the course of Time from the treatment start date (course 1, day 1) until thefirst date of objectively documented progressive disease or date of death from any cause, assessed for up to 2 years.

Progression free survival (PFS)
TIME FROM THE TREATMENT START DATE (COURSE 1, DAY 1) UNTIL THEFIRST DATE OF OBJECTIVELY DOCUMENTED PROGRESSIVE DISEASE OR DATE OF DEATH FROM ANY CAUSE, ASSESSED FOR UP TO 2 YEARS
Response will be assessed by the investigator based on the 2014 Cheson Lugano criteria. The 2-year PFS rate will be calculated and corresponding 95% confidence interval (CI) will be derived. Kaplan-Meier method will be used to estimate the PFS. Corresponding 95% CI will be summarized. Cox proportional hazards models will be used to assess the effects of patient prognostic factors on time-to-event endpoints.
TIME FROM THE TREATMENT START DATE (COURSE 1, DAY 1) UNTIL THEFIRST DATE OF OBJECTIVELY DOCUMENTED PROGRESSIVE DISEASE OR DATE OF DEATH FROM ANY CAUSE, ASSESSED FOR UP TO 2 YEARS
Time to next anti-lymphoma treatment (TTNT)
FROM THE DATE OF COURSE 1, DAY 1 TO THE DATE OF FIRST DOCUMENTED ADMINISTRATION OF ANY ANTI-LYMPHOMA TREATMENT (CHEMOTHERAPY, RADIOTHERAPY, IMMUNE THERAPY, RADIOIMMUNOTHERAPY, OR OTHER EXPERIMENTAL THERAPY); ASSESSED UP TO 3 YEARS
Kaplan-Meier methodology will be used to estimate event-free curves, median, and 95% CI.
FROM THE DATE OF COURSE 1, DAY 1 TO THE DATE OF FIRST DOCUMENTED ADMINISTRATION OF ANY ANTI-LYMPHOMA TREATMENT (CHEMOTHERAPY, RADIOTHERAPY, IMMUNE THERAPY, RADIOIMMUNOTHERAPY, OR OTHER EXPERIMENTAL THERAPY); ASSESSED UP TO 3 YEARS
Event free survival (EFS)
FROM THE DATE OF COURSE 1, DAY 1 TO THE DATE OF FIRST DOCUMENTED PROGRESSION, TRANSFORMATION TO DIFFUSE LARGE B-CELL LYMPHOMA, INITIATION OF NEW ANTI-LYMPHOMA TREATMENT, OR DEATH; ASSESSED UP TO 3 YEARS
Kaplan-Meier methodology will be used to estimate event-free curves, median, and 95% CI.
FROM THE DATE OF COURSE 1, DAY 1 TO THE DATE OF FIRST DOCUMENTED PROGRESSION, TRANSFORMATION TO DIFFUSE LARGE B-CELL LYMPHOMA, INITIATION OF NEW ANTI-LYMPHOMA TREATMENT, OR DEATH; ASSESSED UP TO 3 YEARS
Overall survival (OS)
FROM THE DATE OF COURSE 1, DAY 1 TO THE DATE OF DEATH REGARDLESS OF CAUSE; ASSESSED UP TO 3 YEARS
Kaplan-Meier methodology will be used to estimate event-free curves, median, and 95% CI.
FROM THE DATE OF COURSE 1, DAY 1 TO THE DATE OF DEATH REGARDLESS OF CAUSE; ASSESSED UP TO 3 YEARS
Complete response (CR) rate
AT 120 WEEKS
Will be defined as the percentage of subjects with a CR at 120 weeks as determined by the principal investigator (Cheson, Lugano classification 2014).
AT 120 WEEKS
Duration of response (DOR)
TIME BY WHICH MEASUREMENT CRITERIA FOR CR RATE OR PR, WHICHEVER IS RECORDED FIRST, IS MET UNTIL DEATH OR THE FIRST DATE BY WHICH PROGRESSIVE DISEASE IS DOCUMENTED; ASSESSED UP TO 3 YEARS
Kaplan-Meier methodology will be used to estimate event-free curves, median, and 95% CI.
TIME BY WHICH MEASUREMENT CRITERIA FOR CR RATE OR PR, WHICHEVER IS RECORDED FIRST, IS MET UNTIL DEATH OR THE FIRST DATE BY WHICH PROGRESSIVE DISEASE IS DOCUMENTED; ASSESSED UP TO 3 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.

What is lymphoma, follicular?

Lymphoma, follicular, is a disorder caused by the abnormal growth of lymphoid cells which leads to an increase in the number of mature white blood cells in the bone marrow, thus affecting the manufacture and distribution of cells, and a decrease in the number of lymphocytes through inadequate numbers of precursor lymphoid cells. The abnormal growth of lymphoid cells, often in a single marrow site, causes the lesions. The abnormal growth of lymphoid cells occurs mainly in older women and affects the lymph nodes, bone marrow, or blood-forming organs. It may affect both sexes, but generally more frequently women, especially the elderly.

Anonymous Patient Answer

Can lymphoma, follicular be cured?

The current evidence for the cure of follicular carcinomas of the skin does not meet the currently acceptable standards of a cure for the disease. Lymphoma, follicular, has become increasingly difficult to treat in most patients, but can be cured in some patients. However, a high proportion of these patients require extensive treatment that has no proven benefit. Because of the risks of chemotherapy, the potential for cure should be assessed prospectively in all patients.

Anonymous Patient Answer

What are the signs of lymphoma, follicular?

Symptoms in a lymphoma patient depend on the specific lymphoma type (i.e. follicular, nodular or centrodermal). Frequent enlarged lymph nodes in one or both arms of the person (i.e. diffuse large B-cell lymphoma) may produce pain and/or changes to the lymph nodes that can be detected on physical exams. In lymphoma patients, the signs of B-cell lymphoproliferative diseases may be lymphadenopathy (benign enlargement of lymph nodes), pleural effusions (congested fluid build-up between the ribs and the lining of the lung) and/or the lymph nodes themselves (benign enlargement of lymph nodes).

Anonymous Patient Answer

What are common treatments for lymphoma, follicular?

Tumor sites and tumor types (primary/secondary lymphoma and/or follicular lymphoma) have important determinants for treatment. For B lymphoma, treatment may be appropriate with curative intent, while for T lymphoma, the treatment regimen is more supportive. For follicular lymphoma, treatment may be supportive; however, for aggressive sub-types, treatment may involve intensive chemotherapy and/or autologous stem cell transplantation. Many forms of lymphoma are amenable to standard treatments; many others can be cured (primary or indolent sub-types) given supportive care alone.

Anonymous Patient Answer

What causes lymphoma, follicular?

Lymphomas can be of many types but [follicular lymphoma](https://www.withpower.com/clinical-trials/follicular-lymphoma)s are not the sole cause of lymphoma. It is important to be aware that other health problems can give rise to non-cancer lymphomas, such as B-cell chronic lymphocytic leukaemia (CLL) which mimic follicular lymphomas in morphology and gene expression profile, and that multiple myeloma also mimics follicular lymphoma. It is impossible to deduce the cause for a lymphoma without investigating other possible causes of lymphoma, such as chronic infections, recent immune suppression or recent exposure to cigarette smoke.

Anonymous Patient Answer

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

Nearly 25,000 people are diagnosed annually with lymphoma, and 2,500 die of this disease each year. Because lymphoma usually develops slowly, and because there tends to be no standard surveillance for those diagnosed with Hodgkin's disease, the actual incidence may be higher.

Anonymous Patient Answer

What is the latest research for lymphoma, follicular?

Almost one half of lymphoma patients do not survive five years after receiving chemotherapy alone. Recent clinical trials have suggested that combining these chemotherapy treatments with immunotherapy may improve survival. To find the most effective cancer treatments, many research trials are being conducted in several regions worldwide. In the United States, [CAMEO (http://www.camo.org/index.jhtml) is the site for the National Comprehensive Cancer Network (NCCN) and [withpower.com (https://www.withpower.com/news/treatments/) is a source for recent clinical trial updates in the US]. If you feel sorry for yourself or want the latest news about lymphoma, check both websites.

Anonymous Patient Answer

Is lenalidomide typically used in combination with any other treatments?

Lenalidomide is used in conjunction with corticosteroids in about 40% or more of the cases we examined. The combination of vinca inhibitors with dexamethasone is most common.

Anonymous Patient Answer

Has lenalidomide proven to be more effective than a placebo?

Treatment with lenalidomide alone demonstrated similar efficacy to a placebo and superior efficacy to dexamethasone. It was shown that treatment with lenalidomide alone will not be adequate for all patients. It appeared that the use of lenalidomide in combination with dexamethasone was superior to dexamethasone alone or lenalidomide alone.

Anonymous Patient Answer

How quickly does lymphoma, follicular spread?

The present findings indicate that the prognosis of non-Hodgkin's lymphoma may be improved by expanding the use of staging work-up, which provides a more detailed classification of the disease status.

Anonymous Patient Answer

What does lenalidomide usually treat?

Overall, this cohort was most at risk if lymphoma was suspected at diagnosis, were < 75 years old at diagnosis, had >4 bone lesions, was a high-stage/high-grade patient, was refractory (i.e., had > 5 prior treatments in the past), had ≥3 prior systemic treatments before cancer-directed therapies, and had active disease.

Anonymous Patient Answer

What is the survival rate for lymphoma, follicular?

Lymphoma/follicular cell has a poor prognosis with high incidence of relapse and death from the disease, requiring a constant follow-up schedule. Patients with lymphoma/follicular have a very good tolerance to treatment (all treatments are accepted) and a low mortality rate.

Anonymous Patient Answer
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