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Antimetabolite

Lenalidomide + Nivolumab for Lymphoma

Phase 1
Waitlist Available
Led By Alvaro J Alencar
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically proven primary CNS diffuse large b-cell lymphoma confirmed by one of the following: Brain biopsy or resection, Cerebrospinal fluid, Vitreous fluid
No prior organ transplantation to exclude post-transplant lymphoproliferative disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

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.

Who is the study for?
Adults diagnosed with primary CNS diffuse large B-cell lymphoma who haven't had prior chemotherapy, radiation, or organ/stem cell transplants. They must have a certain level of physical function and adequate blood counts. Pregnant or nursing women are excluded, as well as those with autoimmune diseases that could affect the trial's safety.Check my eligibility
What is being tested?
The trial is testing if adding Lenalidomide to Nivolumab along with usual drugs Rituximab and Methotrexate can improve treatment for primary CNS lymphoma. It aims to find the best dose and see if these drugs can extend control over the cancer after initial success.See study design
What are the potential side effects?
Possible side effects include immune system reactions leading to inflammation in various organs, infusion-related reactions from monoclonal antibodies like Nivolumab and Rituximab, potential blood vessel growth inhibition by Lenalidomide which might affect tumor nutrition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My diagnosis of CNS lymphoma was confirmed through a biopsy or fluid test.
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I have not had an organ transplant.
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I have not had chemotherapy or radiation for lymphoma.
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I have not had a stem cell transplant from a donor.
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I am using steroids for my condition but can reduce them if needed.
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I am not pregnant or nursing and have a negative pregnancy test.
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I am 18 years old or older.
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I can perform daily activities with some assistance.
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My lymphoma is only in my central nervous system.
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I have never had non-Hodgkin lymphoma.
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I do not have an autoimmune disorder that affects my organs or requires steroids.
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I have certain autoimmune conditions like vitiligo or type I diabetes but they are under control.
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I am not on long-term steroids or immunosuppressants, except for low-dose or topical ones.
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I have been checked for serious gut conditions before joining the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose (MTD)
Proportion of evaluable patients who are able to stay on maintenance therapy
Secondary outcome measures
Incidence of adverse events
Overall Survival (OS)
Overall response
+1 more
Other outcome measures
Minimal residual disease (MRD)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (rituximab, methotrexate, lenalidomide, nivolumab)Experimental Treatment11 Interventions
INDUCTION: Patients receive rituximab IV on day 1, methotrexate IV over 2 hours or PO on day 2, lenalidomide PO daily on days 5-14, and nivolumab IV over 30 minutes on day 14. (In dose level IV that includes nivolumab, the doses of rituximab for cycles 2-6 may be given on the same day as nivolumab for the previous cycle). Treatment repeats every 14 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response, partial response, or stable disease proceed to maintenance therapy. MAINTENANCE: Within 6 weeks after the last dose of lenalidomide in induction therapy, patients receive lenalidomide PO daily on days 1-21, and nivolumab IV over 30 minutes on day 1. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI, CT, PET/CT, lumbar puncture, bone marrow aspirate and biopsy, testicular ultrasound and ECHO. (See Detailed Description)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ultrasound Imaging
2018
Completed Phase 4
~730
Rituximab
1999
Completed Phase 4
~1880
Computed Tomography
2017
Completed Phase 2
~2790
Methotrexate
2013
Completed Phase 4
~3800
Magnetic Resonance Imaging
2017
Completed Phase 3
~1310
Lumbar Puncture
2016
Completed Phase 3
~510
Echocardiography
2013
Completed Phase 4
~11670
Lenalidomide
2005
Completed Phase 3
~1480
Nivolumab
2014
Completed Phase 3
~4750
Positron Emission Tomography
2008
Completed Phase 2
~2260

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,603 Previous Clinical Trials
40,913,243 Total Patients Enrolled
Alvaro J AlencarPrincipal InvestigatorAlliance for Clinical Trials in Oncology

Media Library

Methotrexate (Antimetabolite) Clinical Trial Eligibility Overview. Trial Name: NCT04609046 — Phase 1
Diffuse Large B-Cell Lymphoma Research Study Groups: Treatment (rituximab, methotrexate, lenalidomide, nivolumab)
Diffuse Large B-Cell Lymphoma Clinical Trial 2023: Methotrexate Highlights & Side Effects. Trial Name: NCT04609046 — Phase 1
Methotrexate (Antimetabolite) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04609046 — Phase 1

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~2 spots leftby May 2024