Lenalidomide for Follicular Lymphoma ( FL)

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Medizinische Klinik der Universität Tübingen, Tübingen, Germany
Follicular Lymphoma ( FL)+2 More
Lenalidomide - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether lenalidomide when given along with rituximab can help to control the disease and also increase the length of your response (complete or partial response) compared to the standard of care rituximab chemotherapy treatment.

See full description

Eligible Conditions

  • Follicular Lymphoma ( FL)

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Compared to trials

Study Objectives

This trial is evaluating whether Lenalidomide will improve 2 primary outcomes and 8 secondary outcomes in patients with Follicular Lymphoma ( FL). Measurement will happen over the course of Timeframe: CR/CRu rate at 120 weeks.

Week 120
COMPLETE RESPONSE RATE
up to 13 years
Progression Free Survival (PFS)
up to13 years
Event Free Survival (EFS)
Health related quality of life as measured by the EORTC QLQ-C30
Number of participants with adverse events
Overall Survival (OS)
Overall response rate at 120 weeks by International Working Group (IWG) 1999 criteria
Time to Next Anti-Lymphoma Treatment (TTNLT)
Time to Next Chemotherapy Treatment (TTNCT)
Time to Treatment Failure (TTF)

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Compared to trials

Trial Design

2 Treatment Groups

Control
1 of 2
Lenalidomide + Rituximab
1 of 2
Active Control
Experimental Treatment

This trial requires 1030 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 3 and have had some early promising results.

Lenalidomide + RituximabLenalidomide dose 20-mg on days 2-22 every 28 days x 6 cycles, if CR then 10-mg on days 2-22 every 28 days for 12 cycles. PR after 6 cycles, continue 20 mg for 3~6 cycles and then 10 mg on days 2-22 every 28-day cycles for upto 18 cycles Rituximab, 375 mg/m2 on days 1, 8, 15 and 22 of cycle 1, day 1 of cycles 2 to 6; 8 weeks later responding patients continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.
Control• ONE of the following: Rituximab - CHOP, Rituximab - CVP, Rituximab - Bendamustine. 7 to 8 weeks later responding patients will continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
FDA approved
Lenalidomide
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to13 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to13 years for reporting.

Closest Location

Hôpital de l'Enfant-Jesus, CHU de Quebec - Quebec city, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Histologically confirmed CD20+ follicular lymphoma grade 1, 2 or 3a
Have no prior systemic treatment for lymphoma.
Must be in need of treatment
Bi-dimensionally measurable disease with at least one mass lesion > 2 cm that was not previously irradiated.
Stage II, III or IV disease.
Must be ≥ 18 years and sign an informed consent.
Performance status ≤ 2 on the ECOG scale.
Adequate hematological function (unless abnormalities are related to lymphoma infiltration of the bone marrow)
Willing to follow pregnancy precautions

Patient Q&A Section

What are the signs of lymphoma, follicular?

"Signs and symptoms of lymphoma typically indicate the disease, but there may be some overlap with other neoplastic disorders such as thyroid disease.\n\n- Breast Cancer Information Core – Clinical and Genetic Information\n- Breast Cancer Information Center – Signs and Symptoms of Breast Cancer"

"Horsfieldia longifurca\n\nHorsfieldia longifurca (also called long-haired horsfieldia, long-tailed horsfieldia or long-whiskered horsfieldia) is a species of plant in the family Myristicaceae." - Anonymous Online Contributor

Unverified Answer

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

"Around 1.6 million Americans are diagnosed with [follicular lymphoma](https://www.withpower.com/clinical-trials/follicular-lymphoma) a year, and 6.5 million Americans are diagnosed with non-Hodgkin's lymphoma, follicular, a year. These numbers represent the lowest estimates of lymphoma morbidity and mortality since 1950." - Anonymous Online Contributor

Unverified Answer

What are common treatments for lymphoma, follicular?

"Lymphoma and [follicular lymphoma](https://www.withpower.com/clinical-trials/follicular-lymphoma) treatment options and typical chemotherapy regimens are summarized. Lymphoma patients are typically treated with chemotherapy in order to achieve a long-term remission. Patients with follicular and some types of mantle cell disease generally receive either chemotherapy or watchful waiting. More research should focus on novel therapies for relapsed cancers like follicular lymphoma." - Anonymous Online Contributor

Unverified Answer

What is lymphoma, follicular?

"Findings from a recent study showed that nodular peripheral lymphoma had the most aggressive clinical courses with patients experiencing early disease progression or relapse. Patients with less aggressive clinical courses were more likely to present with aggressive lymphomas with multiple sites." - Anonymous Online Contributor

Unverified Answer

What causes lymphoma, follicular?

"Lymphoma, follicular is caused by mutations in genes responsible for a number of signalling pathways. There is limited evidence for other possible causes with the probable exception of the Epstein-Barr virus, which is frequently present in patients with the condition." - Anonymous Online Contributor

Unverified Answer

Can lymphoma, follicular be cured?

"Although there is a high complication rate with therapy, patients with follicular lymphoma can expect and enjoy a better life. This is the second report of a cure for follicular lymphoma." - Anonymous Online Contributor

Unverified Answer

How quickly does lymphoma, follicular spread?

"LFS was shorter in patients who received bortezomib, a VEGF inhibitor, in combination with rituximab. LFS was not affected by the presence of other disease (extranodal disease or age>61 yr); however, there was a significant effect on LFS when patients received bortezomib on the basis of age (P=.068)." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of lenalidomide?

"Lenalidomide has been reported to cause a number of side effects, including nausea, vomiting, fatigue, leukopenia, thrombocytopenia, and diarrhea. Other side effects less frequently include fever, pneumonia, cough, and diarrhea with constipation. Lenalidomide is contraindicated in recipients of organ transplants and pregnant women. If a patient has to interrupt treatment, this can be due to a serious, life-threatening condition. In rare cases, lenalidomide can cause neurological disturbances, including seizures, and severe liver damage as well. The frequency of these effects is not known." - Anonymous Online Contributor

Unverified Answer

Does lymphoma, follicular run in families?

"The family history of cancer has shown no influence on the occurrence of lymphomatous disease. This supports the hypothesis that other genetic factors, or other environmental factors, may play a role in the pathogenesis of lymphoma or lymphomania." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for lymphoma, follicular?

"Patients who meet these criteria should qualify for clinical trials investigating potential therapies for NHL and FTLD:\n1) Primary or relapsing disease (recurrence after treatment) in patients of all ages, with or without previous chemotherapy or radiotherapy exposure, whose disease has progressed and cannot be treated with any existing modalities such as glucocorticoids and methotrexate.\n2) Patients under 40 years of age who have progressive or relapsing disease or have a first-degree family history supporting a genetic predisposition for the disease.\n3) Patients with extranodal disease that progresses despite treatment." - Anonymous Online Contributor

Unverified Answer

How does lenalidomide work?

"Lenalidomide is effective in a variety of B lineage cell malignancies, and its mechanisms of action appear to be associated with a shift in the immunophenotype of B-cells and with deregulation of multiple cell signaling pathways." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of lymphoma, follicular?

"The primary cause in the majority (75%) of cases is EBV-infection in the mantle zone of GCs. The primary cause in 25% of cases remains unclear. EBV-infection leads to increased expression of BCL-6 in B-cells and overexpression of p21 in B-cells as well as in T-cells, which leads to proliferation and multiplication of EBV-infected B-cells and/or T-cells, respectively. This leads to the differentiation of marginal zone B-cells into mantle zone B-cells, which are mostly EBV-negative. It follows that B-cells in the mantle zone of a GC are inactivated in most cases by EBV-infection." - 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.
See if you qualify for this trial
Get access to this novel treatment for Follicular Lymphoma ( FL) by sharing your contact details with the study coordinator.