Lenalidomide for Lymphoma, Follicular

Phase-Based Estimates
1
Effectiveness
1
Safety
Dana-Farber Cancer Institute, Boston, MA
Lymphoma, Follicular+13 More
Lenalidomide - Drug
Eligibility
18+
All Sexes
Eligible conditions
Lymphoma, Follicular

Study Summary

This study is evaluating the side effects and best dose of lenalidomide and ibrutinib when given together with rituximab in treating patients with previously untreated stage II-IV follicular lymphoma.

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Eligible Conditions

  • Lymphoma, Follicular
  • Lymphoma
  • Ann Arbor Stage II Grade 1 Non-Contiguous Follicular Lymphoma
  • Ann Arbor Stage IV Grade 3 Follicular Lymphoma
  • Ann Arbor Stage III Grade 1 Follicular Lymphoma
  • Ann Arbor Stage II Grade 2 Contiguous Follicular Lymphoma
  • Ann Arbor Stage II Grade 3 Contiguous Follicular Lymphoma
  • Ann Arbor Stage II Grade 1 Contiguous Follicular Lymphoma
  • Ann Arbor Stage III Grade 2 Follicular Lymphoma
  • Ann Arbor Stage III Grade 3 Follicular Lymphoma
  • Ann Arbor Stage II Grade 3 Non-Contiguous Follicular Lymphoma
  • Ann Arbor Stage IV Grade 1 Follicular Lymphoma
  • Ann Arbor Stage II Grade 2 Non-Contiguous Follicular Lymphoma
  • Ann Arbor Stage IV Grade 2 Follicular Lymphoma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Lenalidomide will improve 2 primary outcomes, 6 secondary outcomes, and 2 other outcomes in patients with Lymphoma, Follicular. Measurement will happen over the course of 28 days.

28 days
Maximally tolerated dose (MTD) of lenalidomide and ibrutinib for combination with rituximab
Maximally tolerated dose (MTD) of lenalidomide and ibrutinib for combination with rituximab, determined by dose-limiting toxicities (DLT) graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Hour 24
BTK parameters
Week 13
Pharmacokinetic parameters of ibrutinib and major metabolite PCI-45227
Year 10
Overall survival (OS)
Year 10
Progression-free survival (PFS)
Up to 10 years
Complete response rate
Overall response rate
Toxicities by attribute and grade
Toxicities by attribute and grade, assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Treatment (lenalidomide, ibrutinib, and rituximab)

This trial requires 33 total participants across 2 different 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 1 and are in the first stage of evaluation with people.

Treatment (lenalidomide, ibrutinib, and rituximab)Patients receive lenalidomide PO QD on days 1-21 and ibrutinib PO QD on days 1-28. Treatment repeats every 28 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab IV on days 1, 8, 15, and 22 of cycle 1 and once weekly at weeks 13, 21, 29, and 37.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
FDA approved
Rituximab
FDA approved
Lenalidomide
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 10 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 10 years for reporting.

Closest Location

Dana-Farber Cancer Institute - Boston, MA

Eligibility Criteria

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.

Mark “yes” if the following statements are true for you:
Previously untreated, histologically confirmed follicular lymphoma, World Health Organization (WHO) classification grade I, II, or IIIa (> 15 centroblasts per high power field with centrocytes present) that is stage III, IV, or bulky (i.e., single mass >= 7 cm in any unidimensional measurement) stage II and requires therapy at the discretion of the primary physician
Failure to submit pathology specimens within 60 days of patient registration will be considered a major protocol violation
Institutional flow cytometry or immunohistochemistry must confirm cluster of differentiation 20 (CD20) antigen expression
Bone marrow biopsies as the sole means of diagnosis are not acceptable, but they may be submitted in conjunction with nodal biopsies; fine needle aspirates are not acceptable for diagnosis
All risk by follicular lymphoma international prognostic index (FLIPI): 0-5 risk factors
No prior systemic therapy for non-Hodgkin lymphoma (NHL) including chemotherapy or immunotherapy (e.g., monoclonal antibody-based therapy), radiation therapy, or radioimmunotherapy
For non-NHL conditions, no chemotherapy, radiotherapy, or major surgery within 4 weeks (6 weeks for nitrosoureas or mitomycin C) of enrollment; no patients who have ongoing adverse events from agents administered more than 4 weeks previously
No prior exposure to any of the study agents
No corticosteroids within two weeks prior to study entry, except for maintenance therapy for a non-malignant disease; dose of corticosteroid or prednisone (or its equivalent) should not exceed 20 mg per day; corticosteroid premedication for rituximab is allowed
Eastern Cooperative Oncology Group (ECOG) performance status must be =< 2

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, follicular be cured?

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Patient and pathologic features and their inter-relations are the best predictors of the outcome of any type of non-Hodgkin's lymphoma. Lymphoma responds well to chemotherapy but not to surgery, radiotherapy, or bone marrow transplantation. Treatment modalities that are often in use, such as surgery, radiotherapy, intensive chemotherapy, and hematopoietic-cell salvage have a relatively low complete response rate. In addition, treatment failures, non-relapsing disease occurring after treatment cessation, and progression of disease from a nadir after successful treatment result in a high disease progression rate in non-Hodgkin's lymphoma.

Unverified Answer

What causes lymphoma, follicular?

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Lymphoplvoma has multiple etiologies including genetic, immunological, and environmental factors. Risk factors associated with lymphoma may include infection, drugs, and exposure to carcinogens. The most common types of lymphoma in men and women are non-Hodgkin's lymphoma, nodular lymphoma, splenic marginal zone lymphoma, and follicular lymphoma.

Unverified Answer

What are the signs of lymphoma, follicular?

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Signs of lymphoma, follicular include a rapidly enlarging lymphadenopathy (including those arising in the mediastinum via the subclavian artery), a B symptom (such as fever, night sweats or weight loss), and an abnormal result from bone marrow examination. A high-grade lymphoma does not cause a B symptom. Lymphoma, follicular can be diagnosed in an individual if positive serum lymphocyte markers (e.g., elevated gamma glutamyl transpeptidase) are present, the B symptom is present, or bulky lymphadenopathy is present.

Unverified Answer

What is lymphoma, follicular?

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The lymphoma, follicular is a histopathologic category that is characterized by the growth of abnormal lymphocytes (i.e. germinal center cells) in follicles. The disorder can frequently be diagnosed in children and there seems to be no sex preference. Although the disease shows characteristic histopathologic features that are present in children and adults, the diagnosis depends upon whether the patient is >18 years old. The disease is rare and tends to progress rapidly. However, lymphoma, follicular is not a rare disease in children. The disease has several types and it may not always be the neoplastic type that is the focus of the diagnosis.

Unverified Answer

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

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The incidence of lymphoma is low in the United States with an annual rate of 1.8 cases per 100,000. The incidence is higher in the elderly. While not statistically significant, the age of diagnosis for follicular and diffuse large-cell lymphomas was higher than that for all chronic lymphocytic leukemias.

Unverified Answer

What are common treatments for lymphoma, follicular?

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Chemical chemotherapy is the most frequently used treatment for [follicular lymphoma](https://www.withpower.com/clinical-trials/follicular-lymphoma). Radiation may be used to treat stage III or IV follicular lymphoma. Radiation therapy is an effective method of treating cervical lymphoma (stage IA). Lymphoma, follicular, may be managed by surgery alone. Chemotherapy is the preferred treatment for advanced lymphoma of the stomach and intestine. Treatment for Hodgkin's disease is highly dependent on the stage of disease. Localized irradiation of Hodgkin's disease can cure the disease, but is usually restricted to the early stages of untreated disease. Radiation therapy and chemotherapy alone for patients with advanced disease is the standard of care.

Unverified Answer

How does lenalidomide work?

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Overall outcome data show very high remission rates compared to other IMDs based on both clinical trials and clinical experience. This was in particular true for bortezomib/lenalidomide. Patients with FL were more likely to achieve remissions, whereas those with mantle-cell lymphoma (MCL) were more likely to achieve complete responses. It should be kept in mind that our cohort of patients was very narrow, as all patients suffered from FL. For that reason, the overall response rate to lenalidomide in FL was relatively small, making comparison to other IMDs problematic.

Unverified Answer

What are the latest developments in lenalidomide for therapeutic use?

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Treatment of refractory or refractory relapsed lymphoma and myeloma in post-HSCT is worthwhile.Lenalidomide is an active agent with good tolerability, but there are no major differences in treatment efficacy, time to progression of disease or time to progression of disease to progression of disease when comparing different regimens. Randomised, controlled, phase III studies are warranted to assess long-term efficacy of lenalidomide-containing regimens.

Unverified Answer

Is lenalidomide typically used in combination with any other treatments?

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Lenalidomide is used alone or in combination with other treatments. The most common treatment combinations are lenalidomide and ATG or thalidomide. Lenalidomide-based regimens have been most commonly administered in treatment-naive patients, and lenalidomide has also been used as maintenance therapy. Lenalidomide is not a commonly used treatment or prophylaxis in patients with myelodysplastic/myeloproliferative disorders.

Unverified Answer

What does lenalidomide usually treat?

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There are many different kinds of lymphomas. The most common types of lymphoma are diffuse large B-cell lymphomas and follicular lymphomas. The two types are not the only types of lymphoma that are common. Even though it is not part of the standard of care for lymphoma to mention which type of lymphoma is the underlying disease, it is very useful to be able to pinpoint the type, as certain kinds of lymphomas that are highly responsive to treatments can be very dangerous when misdiagnosed. Lenalidomide has been shown to be very effective for most kinds of lymphomas, but it may not work the same for all cases.

Unverified Answer

Who should consider clinical trials for lymphoma, follicular?

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There was no difference in response rates between trials with follicular lymphoma and those with non-follicular NHLs. Clinicians may consider the patient's age, baseline performance status, and disease burden in determining if clinical trial participation is appropriate.

Unverified Answer

Is lenalidomide safe for people?

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There is ample evidence of its antitumor activity and its safety in people with lymphoma, justifying its place as the gold standard for maintenance therapy in the setting of first-line regimens and at other stages of therapy.

Unverified Answer
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