lenalidomide for Lymphoma

Phase-Based Estimates
1
Effectiveness
2
Safety
Weill Cornell Medical College, New York, NY
Lymphoma+2 More
lenalidomide - Drug
Eligibility
18+
All Sexes
Eligible conditions
Lymphoma

Study Summary

This study is evaluating whether a combination of lenalidomide and rituximab is safe and effective for people with mantle cell lymphoma.

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Eligible Conditions

  • Lymphoma
  • Lymphoma, Mantle-Cell
  • Mantle Cell Lymphoma (MCL)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether lenalidomide will improve 1 primary outcome and 4 secondary outcomes in patients with Lymphoma. Measurement will happen over the course of 30 months.

10 years
Overall Survival
Progression-free Survival
Safety as Measured by Number of Subjects Who Experience an Adverse Event While on Study Treatment
Time to Next Treatment
30 months
Overall Response Rate

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Compared to trials

Trial Design

2 Treatment Groups

Control
all patients

This trial requires 38 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 2 and have already been tested with other people.

all patientsInduction Phase (week 1 - 48): Lenalidomide will be given at 20 mg/day for days 1-21 of a 28-day cycle for 12 cycles. If no excess toxicity is observed the dose will be increased to 25 mg/day. Rituximab will be administered at 375 mg/m2 per dose for a total of 9 doses. The first 4 doses will be administered weekly starting on day 1 of lenalidomide (e.g. days 1, 8, 15 and 22). Subsequent rituximab doses will be administered for one dose each at weeks 12, 20, 28, 36 and 44. Maintenance Phase (week 49 - progression of disease): Lenalidomide will be given at 15 mg/day for days 1-21 of a 28-day cycle. Rituximab at 375 mg/m2 per dose will be administered for one dose every 8 weeks, starting at week 52.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
FDA approved
Rituximab
FDA approved

Trial Logistics

Trial Timeline

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

Closest Location

Weill Cornell Medical College - New York, NY

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:
Sign an informed consent form in order to fully understand the study and its risks and benefits. show original
The subject feels that chemotherapy is not necessary. show original
The patient has a mass measuring over 1.5 cm in at least one dimension. show original
The person must be at least 18 years old when they sign the form. show original
The patient has a histologically confirmed diagnosis of mantle cell Non-Hodgkin's Lymphoma and the tumor tissue overexpresses cyclin D1 show original
MIPI score is used to classify cancer risk show original
This study is for people with lymphoma who have not received any previous systemic therapy, including chemotherapy and immunotherapy show original
The person is able to follow the study schedule and other requirements. show original
The ECOG performance status was equal to or less than 2 at the time of study entry. show original
This means that the absolute neutrophil count is more than or equal to 1000 per cubic millimeter. show original

Patient Q&A Section

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

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

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The incidence of lymphoma in the USA has been falling since the early 1970s; however, it remains a significant public health problem with more than 20,000 new cases diagnosed in America in 2005, which is an increase against the 1975 rate. This is despite a decrease in PBL, which is the most common type. This result is the result of improved detection efforts and earlier diagnosis which in turn leads to a lower number of new cases being seen in secondary care. The USA is unlikely to achieve reductions in lymphoma incidence.

Unverified Answer

What are common treatments for lymphoma?

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There are no common treatments for both cutaneous and non-cutaneous lymphomas. Cutaneous lymphomas account for about 25% of lymphomas and are treated by chemotherapy alone or in some cases, combined with radiation treatments, immunotherapy, immunochemotherapy or a combination of these. Non-cutaneous lymphomas can be treated with steroids with or without chemotherapy, and in some cases, radiation therapies only. The optimal treatment for lymphoma depends on the subtype and the patient's disease stage at the time of diagnosis and treatment. Other treatments include surgery. There are multiple lymphoma types. Lymphoma treatments have changed over the years.

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Can lymphoma be cured?

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Lymphoma can be cured; however, this is only achieved in a small proportion of cases. A combination of the current therapeutic approach, chemotherapy, with the use of rituximab, a drug designed to target B-cell surface receptors, is the most effective treatment for lymphoma.

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What causes lymphoma?

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About one out of every three men between 15-39 years old will probably develop lymphoma by the age of 65, while about one in three women of this age group will receive a diagnosis of lymphoma at some time. At the same time, the risk for developing lymphoma seems to be higher if the mother was diagnosed with Hodgkin's lymphoma during pregnancy. Lymphoma in children and adolescents may come with a tendency towards other malignancies, such as Hodgkin's lymphoma or leukaemia.

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What are the signs of lymphoma?

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A variety of physical changes may occur as a result of cancer, such as changes in the size of the eyes or ears. A change in the colour of the mucosa of the mouth may also occur. Other possible signs of lymphoma include the feeling of a lump or lump in the body. Narrowing of the opening of one of the rectal openings may also occur, causing people with lymphoma to lose stool through the opening. Lymphoma may also be evident on an X-ray of the brain, where there may be signs of swelling around major arteries. Lymphoma will often cause severe pain, which may cause nausea, sweating and shortness of breath.

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What is lymphoma?

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Lymphomas, especially lymphomas involving the central nervous system, are of particular concern because they have a high risk of spread to the brain. The WHO recommends MRI scans for patients diagnosed with a tumor of the central nervous system, and lymphatic mapping in these cases.

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What is the primary cause of lymphoma?

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Results of this preliminary study revealed risk factors for a number of lymphomas, but it is necessary to replicate these findings and investigate the contribution of the main risk factors in future studies. The most common cause of NHL in the population studied was infectious causes.

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Does lymphoma run in families?

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Results from a prospective study did not demonstrate the occurrence of familial disease among all patients having a diagnosis of NHL or its variants. The study results are compatible with current recommendations, that the most common familial occurrence is the inheritance of a single tumor type, with a slight predisposition toward breast and skin tumors.

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Does lenalidomide improve quality of life for those with lymphoma?

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Lenalidomide treatment is associated with a significant improvement in quality of life. The effect is dose-dependent, and there is no difference between the 40% or 100% dose levels.

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What is lenalidomide?

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Lenalidomide is approved in the European Union (EU) and the US for the treatment of people with myelodysplastic syndrome. In 2011 the FDA approved it for the treatment of people with chronic lymphocytic leukaemia (CLL) who have had at least two previous lines of treatment. Lenalidomide may be used as a first-line therapy in follicular lymphoma. However, there is no well-designed clinical trial to demonstrate equivalency of lenalidomide to other chemotherapy regimens in people with follicular lymphoma. In this retrospective study, lenalidomide was used as first-line therapy in people with follicular lymphoma.

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How serious can lymphoma be?

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Despite all the advances in cancer research in the 20th century, there have been no gains in the understanding of the disease and its biology and, as such, the treatment has remained largely unrefined with a high degree of individualization. This may explain why the quality of treatments has remained dismal with the 5-year relative survival only 20% with all modal treatments and 16% with a combination of treatments.

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Has lenalidomide proven to be more effective than a placebo?

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On the pooled basis, our meta-analysis showed that lenalidomide did not provide greater improvement than placebo in terms of objective response or rate of remission but it had fewer side effects than ondansetron and provided higher response rates. Long-term safety and quality of life will also need to be evaluated.

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