Ibrutinib for Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Wisconsin Hospital and Clinics, Madison, WI
Lymphoma+7 More
Ibrutinib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether ibrutinib is effective in treating patients with follicular lymphoma that has come back after a period of improvement or does not respond to treatment.

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Eligible Conditions

  • Lymphoma
  • Refractory Follicular Lymphoma
  • Recurrent Grade 3 Follicular Lymphoma
  • Grade 3a Follicular Lymphoma
  • Recurrent Grade 2 Follicular Lymphoma
  • Recurrent Grade 1 Follicular Lymphoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Ibrutinib will improve 1 primary outcome and 6 secondary outcomes in patients with Lymphoma. Measurement will happen over the course of Time from the date at which the patient's objective status is first noted to be a CR or PR to the earliest date progression is documented, assessed up to 5 years.

Year 5
Overall Survival
Year 5
Progression-free Survival
Year 5
Time to Subsequent Treatment
Year 5
Time to Treatment Failure
Year 5
Duration of Response
Year 5
Time to Response
Up to 5 years
Overall Response Rate

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Treatment (ibrutinib)
1 of 1
Experimental Treatment

This trial requires 41 total participants across 1 different treatment group

This trial involves a single treatment. 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.

Treatment (ibrutinib)Patients receive ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease at the end of course 2 may continue on therapy until the end of course 5 at the discretion of the treating physician.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 5 years for reporting.

Closest Location

University of Wisconsin Hospital and Clinics - Madison, WI

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Lymphoma or one of the other 7 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Histologically confirmed diagnosis of follicular lymphoma, grade 1, 2, or 3a
Note: Fresh (frozen) tumor biopsy must be available or attempted; a frozen tumor biopsy equivalent to a minimum of four at least 16 gauge needle cores is an important component of this study; patients without adequate frozen material should have a biopsy performed to obtain material; if biopsy is performed and does not yield adequate material, the patient is still eligible for the study; if a biopsy cannot be done safely, the patient may still be eligible for the study if permission is granted in writing (email) by the study chair (Dr. Nancy Bartlett) or her designees; Dr. Bartlett may be consulted to discuss situations involving invasive biopsy procedures that may pose an increased risk to the patient
Measurable disease as defined by a lymph node or tumor mass that is >= 1.5 cm in at least one dimension by CT or the CT portion of the PET/CT
Relapsed or refractory follicular lymphoma which has progressed during or following 1 or more prior chemotherapy regimens for lymphoma
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
Absolute neutrophil count >= 750/mm^3 (0.75 x 10^9/L)
Hemoglobin >= 8.0 g/dL
Platelets >= 30,000/mm^3 (30 x 10^9/L)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) unless Gilbert's syndrome or disease infiltration of the liver is present
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.0 x institutional ULN

Patient Q&A Section

What causes lymphoma, follicular?

"In the United States, most lymphomas are non-Hodgkin's lymphoma originating in B Cell lineage, and the majority are diffuse large cell non-Hodgkin's lymphoma (accounting for about 40% of all lymphomas). The most common underlying causes of non-Hodgkin's lymphoma are infection with high-grade B cells, including chronic lymphocytic leukemia, and smoking. The most common cause of follicular lymphoma is follicular non-Hodgkin's lymphoma.\n\nThere are various risk factors associated with lymphoma." - Anonymous Online Contributor

Unverified Answer

What are common treatments for lymphoma, follicular?

"Patients with lymphoma are treated with chemotherapy for several weeks, and patients with follicular lymphoma usually receive treatments for six or more months, which may include immunotherapy, radiotherapy, or surgery." - Anonymous Online Contributor

Unverified Answer

Can lymphoma, follicular be cured?

"This report offers another argument for active treatment of indolent lymphomas, even though they may persist for an extended period. Lymphomas are probably curable by careful, local treatment if the disease is restricted to the lymph nodes near the original site of disease." - Anonymous Online Contributor

Unverified Answer

What is lymphoma, follicular?

"Lymphoma, follicular, is a disease that begins in the B lymphocytes and spreads to another part of the body. It can cause weight loss, blood problems, fatigue, and feeling sick; it can be caused by or be associated with certain cancers, autoimmune disorders, or viral infections. Lymphoma, follicular, is typically found in older people; it is diagnosed by a doctor using blood tests, scans, or other tests to assess tissue in the body. The disease was first described in 1852." - Anonymous Online Contributor

Unverified Answer

What are the signs of lymphoma, follicular?

"Many signs and symptoms of lymphoma are nonspecific. People with lymphoma sometimes present without detectable symptoms, while a person with nonlymphoma lymphadenopathy can have nonspecific presentations." - Anonymous Online Contributor

Unverified Answer

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

"About 30,000 people will be diagnosed with histiocytic and B cell lymphoma in 2006 in the US. Those with lymphoma may be diagnosed in the more than one year after the diagnosis of rheumatic disease even if there is a chronic form of arthritis/arthralgia. Therefore, it is important for physicians to think of autoimmune syndromes in their differential diagnosis in their patients with autoimmune diseases and lymphoma in particular." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of ibrutinib?

"Ibrutinib in combination with paclitaxel had a low rate or serious side effect rates (<5%). A significant fraction of patients who experienced any serious side effect dropped from the study early. The most common side effects were infection, anemia, rash and/or itch. Less common, but more common than serious, side effects were neutropenia, peripheral edema, diarrhea and fatigue. One-half of the patients had to decrease their dosage of ibrutinib as a result of side effects." - Anonymous Online Contributor

Unverified Answer

How serious can lymphoma, follicular be?

"The number of deaths from follicular lymphoma is low; over 90% of cases are diagnosed after death. The risk of death also varies with site of disease. The 5-year overall survival rate is 63%; the 5-year relapse-free survival rate is 58%. The major prognostic factors were patient age at diagnosis, number of involved sites, stage of disease and initial treatment. We recommend that patients of all age groups with follicular lymphoma be treated with the standardized protocol recommended by the National Comprehensive Cancer Network." - Anonymous Online Contributor

Unverified Answer

What is the latest research for lymphoma, follicular?

"Lymphoma, follicular represents a challenge for treatment of disease that is currently devastating and unpredictable. Clinical trials are being done to identify new therapies. The treatment options currently available to patients with this disease are limited and the long-term outcome and prognosis are dismal. The development of new treatment strategies for lymphoma, follicular is essential." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing lymphoma, follicular?

"While it is not possible to state in exact terms the odds of lymphoma occurring at a given period, there is a greater likelihood of developing lymphoma if one is born with a history of immune suppression as a youngster. When looking at the risks, the most important factor is a person's age at the time of diagnosis. If one's diagnosis is made in the first 20 years of life, the one-year risk of developing lymphoma is approximately 40%. However, if diagnosis is made later in one's life, that same risk of developing non-Hodgkin's lymphoma is approximately 10%. Overall, about 7% of people with lymphoma develop it, of whom about 2% will develop the follicular type." - Anonymous Online Contributor

Unverified Answer

How does ibrutinib work?

"This preliminary report from Phase I studies suggests that this ALK / PI3K inhibitor is well-tolerated as a single agent and can overcome both acquired and intrinsic resistance. Ibrutinib may therefore be useful in treating some patients who do not respond well to the FDA-approved kinase inhibitors with this common kinase pathway activated in many types of cancer." - Anonymous Online Contributor

Unverified Answer

Has ibrutinib proven to be more effective than a placebo?

"This phase II study with ibrutinib showed that ibrutinib and its metabolites effectively control progression of cutaneous T-cell lymphoma and the effects were superior to controls. Ibrutinib is highly effective in this disease, and thus warrants further investigation as a therapeutic option." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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