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Bruton's Tyrosine Kinase Inhibitor

Lenalidomide + Ibrutinib for Lymphoma

Q: What afflictions is Pharmacological Study mainly applied to?

Pharmacological Study has demonstrated efficacy in <a href="https://www.withpower.com/clinical-trials/amyloidosis">amyloidosis</a> and other disease-states such as <a href="https://www.withpower.com/clinical-trials/lymphoma">lymphoma</a>, refractory diffuse large b cell lymphoma (dlbcl), and <a href="https://www.withpower.com/clinical-trials/muscular-dystrophy">muscular dystrophy</a>.

Q: To what extent is this trial being populated by volunteers?

This research project is no longer seeking participants. It was first posted on September 13th 2013 and underwent its last update on July 28th 2022. Alternatively, there are 2718 studies actively recruiting those with <a href="https://www.withpower.com/clinical-trials/lymphoma">lymphoma</a> or large b-cell diffuses as well as 412 Pharmacological Studies accepting enrollees currently.

Q: What is the main goal of this experiment?

This medical study, taking place over a two year period, aims to determine the maximum tolerated dose. Secondary goals include measuring overall response duration through descriptive statistics and assessing degree of response by utilizing International Harmonization Project <a href="https://www.withpower.com/clinical-trials/lymphoma">Lymphoma</a> Response Criteria as well as Waldenstrom's Macroglobulinemia Response criteria while also summarizing data on stable disease duration.

Q: Can you provide information about prior investigations involving Pharmacological Study?

Currently, 412 trials researching Pharmacological Study are being conducted. Of those studies, 79 have reached the third stage of clinical development. Most of these investigations can be found in Chicago, <a href="https://www.withpower.com/clinical-trials/illinois">Illinois</a>; however there are 20383 other locations running related experiments.

Q: Are individuals currently being accepted into the experiment?

This trial is no longer actively recruiting participants. The posting was first published on September 13th 2013 and most recently updated on July 28th 2022. If you are searching for other studies, there are 2718 clinical trials in search of patients with <a href="https://www.withpower.com/clinical-trials/lymphoma">lymphoma</a>, large b-cell diffuse and 412 Pharmacological Studies currently enrolling volunteers.

Q: Has the FDA approved this pharmaceutical research?

With limited safety and efficacy data, the risk associated with this clinical trial scored a 1 on our assessment scale.

Phase 1

Waitlist Available

Led By Beth A Christian

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

Curative therapy must have been exhausted or not feasible to administer

Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial is testing the side effects and best dose of lenalidomide and ibrutinib for patients with B-cell non-Hodgkin lymphoma.

Who is the study for?

This trial is for adults with certain types of B-cell non-Hodgkin lymphoma that have relapsed or are refractory. Participants must have had at least one prior therapy, be in fairly good health (ECOG <=2), and not pregnant or nursing. They should understand the study and consent to participate. Those with active infections, recent major surgery, known allergies to trial drugs, or on specific medications are excluded.Check my eligibility

What is being tested?

The trial is testing the combination of two drugs: Lenalidomide and Ibrutinib. It aims to find the safest dose while assessing how well these drugs work together against various subtypes of B-cell non-Hodgkin lymphoma compared to using them separately.See study design

What are the potential side effects?

Potential side effects include fatigue, digestive issues like nausea or diarrhea, blood cell count changes leading to increased infection risk or bleeding problems, liver function abnormalities, allergic reactions, and possibly heart rhythm disturbances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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All possible curative treatments have been tried or are not suitable for me.

Select...

I can take care of myself but might not be able to do active work.

Select...

My lymphoma is a specific type of B-cell non-Hodgkin's.

Select...

I am 18 years old or older.

Select...

My organs and bone marrow work well without needing extra help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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

Incidence of toxicity according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 criteria

Maximum tolerated dose (MTD)

Secondary outcome measures

Degree of response

Duration of overall response

Duration of stable disease

+2 more

Other outcome measures

Change in pharmacodynamic markers including TH1 and TH2 cytokines, ex vivo NK cell cytotoxicity, serum microRNAs, plasma metabolites, and levels of Bruton's tyrosine kinase occupancy and other selected kinases

Changes in B- T-, and NK- cell subsets

Changes in quantitative immunoglobulin levels

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (lenalidomide, ibrutinib)Experimental Treatment8 Interventions

Patients receive lenalidomide PO on days 1-21 and ibrutinib PO on days 1-28 (days 2-28 of cycle 1). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection and CT or PET/CT throughout the study. Patients may undergo bone marrow biopsy and aspiration and MRI as clinically indicated.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bone Marrow Biopsy

2021

Completed Phase 2

~10

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Bone Marrow Aspiration

2011

Completed Phase 2

~1740

Computed Tomography

2017

Completed Phase 2

~2720

Biospecimen Collection

2004

Completed Phase 2

~1700

Positron Emission Tomography

2008

Completed Phase 2

~2240

Ibrutinib

2014

Completed Phase 4

~1890

Lenalidomide

2005

Completed Phase 3

~1480

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,687 Previous Clinical Trials

40,930,337 Total Patients Enrolled

Beth A ChristianPrincipal InvestigatorOhio State University Comprehensive Cancer Center

Media Library

Ibrutinib (Bruton's Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01955499 — Phase 1

Diffuse Large B-Cell Lymphoma Research Study Groups: Treatment (lenalidomide, ibrutinib)

Diffuse Large B-Cell Lymphoma Clinical Trial 2023: Ibrutinib Highlights & Side Effects. Trial Name: NCT01955499 — Phase 1

Ibrutinib (Bruton's Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01955499 — Phase 1

Frequently Asked Questions

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

What afflictions is Pharmacological Study mainly applied to?

"Pharmacological Study has demonstrated efficacy in amyloidosis and other disease-states such as lymphoma, refractory diffuse large b cell lymphoma (dlbcl), and muscular dystrophy."

Answered by AI

To what extent is this trial being populated by volunteers?

"This research project is no longer seeking participants. It was first posted on September 13th 2013 and underwent its last update on July 28th 2022. Alternatively, there are 2718 studies actively recruiting those with lymphoma or large b-cell diffuses as well as 412 Pharmacological Studies accepting enrollees currently."

Answered by AI

What is the main goal of this experiment?

"This medical study, taking place over a two year period, aims to determine the maximum tolerated dose. Secondary goals include measuring overall response duration through descriptive statistics and assessing degree of response by utilizing International Harmonization Project Lymphoma Response Criteria as well as Waldenstrom's Macroglobulinemia Response criteria while also summarizing data on stable disease duration."

Answered by AI

Can you provide information about prior investigations involving Pharmacological Study?

"Currently, 412 trials researching Pharmacological Study are being conducted. Of those studies, 79 have reached the third stage of clinical development. Most of these investigations can be found in Chicago, Illinois; however there are 20383 other locations running related experiments."

Answered by AI

Are individuals currently being accepted into the experiment?

"This trial is no longer actively recruiting participants. The posting was first published on September 13th 2013 and most recently updated on July 28th 2022. If you are searching for other studies, there are 2718 clinical trials in search of patients with lymphoma, large b-cell diffuse and 412 Pharmacological Studies currently enrolling volunteers."

Answered by AI