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Lenalidomide for Central Nervous System Lymphoma

Mercy Medical Center - Des Moines, Des Moines, IA
Central Nervous System Lymphoma+1 More ConditionsLenalidomide - Drug
Eligibility
18+
All Sexes

Study Summary

This trial is to find out the best dose of lenalidomide when added to nivolumab and the usual drugs (rituximab and methotrexate) in patients with primary central nervous system (CNS) lymphoma. Lenalidomide may stop or slow primary CNS lymphoma by blocking the growth of new blood vessels necessary for tumor growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread.

Eligible Conditions
  • Central Nervous System Lymphoma
  • Non-Hodgkin's Lymphoma

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

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Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Up to 5 years

Time from start of induction treatment to death due to any cause
Overall Survival (OS)
Time from start of induction treatment to progression or death due to any cause
Progression free survival (PFS)
Up to 5 years
Incidence of adverse events
Minimal residual disease (MRD)
Overall response
Up to 6 months
Maximum tolerated dose (MTD)
Proportion of evaluable patients who are able to stay on maintenance therapy

Trial Safety

Phase-Based Safety

1 of 3

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1
Voraxaze
1
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Side Effects for

Phase 1 and Phase II: Event Free Survival and Overall Survival
44%Neutrophil count decreased
8%Infusion related reaction
8%Weakness
6%Fever
6%Fatigue
6%Platelet count decreased
6%Investigations - Other, specify
3%Hypokalemia
3%Infections and infestations - Other, specify
3%Left ventricular systolic dysfunction
3%Atrial fibrillation
3%Respiratory Failure
3%Myocardial infarction
3%sepsis
3%Chest pain
3%Pleural effusion
3%Atrial flutter
3%Cardiac arrest
3%Renal and urinary disorders - Other, specify
3%Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
3%Respiatory, thoracic and mediastinal disorders - Other, specify
3%confusion
3%Respiratory, thoracic and medicastinal disorders - Other, specify
3%Abdominal Pain
3%Nausea
3%Injury, poisoning and procedural complications - Other, specify
3%Acidosis
3%Cough
3%Encephalopathy
3%Aortic valve disease
This histogram enumerates side effects from a completed 2018 Phase 1 & 2 trial (NCT01060384) in the Phase 1 and Phase II: Event Free Survival and Overall Survival ARM group. Side effects include: Neutrophil count decreased with 44%, Infusion related reaction with 8%, Weakness with 8%, Fever with 6%, Fatigue with 6%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

1 Treatment Group

Treatment (rituximab, methotrexate, lenalidomide, nivolumab)
1 of 1

Experimental Treatment

32 Total Participants · 1 Treatment Group

Primary Treatment: Lenalidomide · No Placebo Group · Phase 1

Treatment (rituximab, methotrexate, lenalidomide, nivolumab)Experimental Group · 5 Interventions: Magnetic Resonance Imaging, Rituximab, Nivolumab, Lenalidomide, Methotrexate · Intervention Types: Procedure, Biological, Biological, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Rituximab
FDA approved
Nivolumab
FDA approved
Lenalidomide
FDA approved
Methotrexate
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,283 Previous Clinical Trials
41,235,366 Total Patients Enrolled
8 Trials studying Central Nervous System Lymphoma
445 Patients Enrolled for Central Nervous System Lymphoma
Alvaro J AlencarPrincipal InvestigatorAlliance for Clinical Trials in Oncology

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have not received chemotherapy or radiation therapy before for lymphoma.
You cannot take blood thinners like aspirin, warfarin or newer oral blood thinning medications.
You have a history of acute diverticulitis or other conditions that increase the risk of bowel perforation. You will need to be evaluated to determine if additional treatment is needed before participating in the study.
You do not have any other active cancer that is currently being treated.
You are not participating in any other experimental treatment.
You have not had a stem cell transplant from someone else before.
You are allowed to use corticosteroids to manage symptoms, but the dosage must be reduced gradually.
You have not had an allergic reaction to similar drugs or substances used in this study.
You can participate in the study if you have vitiligo, type I diabetes, underactive thyroid due to an autoimmune condition that's managed with hormone replacement, or psoriasis that doesn't require medication. Also, if you have a condition that's not likely to return unless triggered by external factors.
References

Frequently Asked Questions

What is the current regulatory status of Lenalidomide?

"Lenalidomide scores 1 out of 3 on our safety scale as it is a Phase 1 trial, meaning there are few studies to support efficacy and limited evidence related to safety." - Anonymous Online Contributor

Unverified Answer

Are there currently opportunities to participate in this trial?

"Affirmative. According to information on clinicaltrials.gov, this trial is still admitting individuals for participation and was initially posted in January 2021 with the most recent update occurring in November 2022. A total of 32 patients are required from a pool of 32 medical centres involved in the study." - Anonymous Online Contributor

Unverified Answer

Has lenalidomide been subject to previous research studies?

"In 1993, lenalidomide's clinical trials first began at the National Institutes of Health Clinical Center located in Rockville Pike. Since then, a total of 1908 different studies have been completed with 1487 still running today; many are hosted by Weston, Wisconsin." - Anonymous Online Contributor

Unverified Answer

In what circumstance is Lenalidomide most commonly prescribed?

"Primarily, lenalidomide is administered to those with metastatic urothelial carcinoma of the ureter. Yet this therapeutic agent may also aid individuals suffering from malignant melanoma of skin, chronic lymphocytic leukemia, and metastatic hepatocellular carcinoma." - Anonymous Online Contributor

Unverified Answer

How widely distributed is this clinical test being performed?

"This experiment is being conducted at Marshfield Medical Center - Weston in Weston, Wisconsin, Huntsman Cancer Institute/University of Utah in Salt Lake City, Utah and at Marshfield Medical Center-Rice Lake in Rice Lake, Texas. Moreover, 32 additional sites are involved as well." - Anonymous Online Contributor

Unverified Answer

To what extent are participants enrolled in this clinical experiment?

"To fulfill the requirements of this trial, 32 eligible patients need to be enrolled. Those seeking participation can visit Marshfield Medical Center - Weston in Weston, Wisconsin and Huntsman Cancer Institute/University of Utah in Salt Lake City, Utah for further details." - Anonymous Online Contributor

Unverified Answer

What is the intent of this medical experiment?

"The primary purpose of this 6 month clinical trial is to determine the Maximum Tolerated Dose (MTD). Secondary objectives include estimating Overall Response Rate, Incidence of Adverse Events and Progression-Free Survival. For each outcome, descriptive statistics will be employed such as exact binomial 95% confidence intervals for response rate and Kaplan-Meier estimates for PFS." - 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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