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Kinase Inhibitor
Radiation Therapy for Follicular Lymphoma
Phase 1 & 2
Waitlist Available
Led By Ronald Levy
Research Sponsored by Robert Lowsky
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 months
Awards & highlights
Study Summary
This trial is testing the side effects and best dose of an immunostimulant given with a cancer drug and radiation therapy for patients with lymphoma that has returned after a period of improvement or stopped responding to treatment.
Eligible Conditions
- Follicular Lymphoma Grade 1
- Follicular Lymphoma
- Mantle Cell Lymphoma
- Marginal Zone Lymphoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of dose-limiting toxicity assessed using Common Terminology Criteria for Adverse Events version 4.0 (Phase Ib)
Tumor response rates (Phase II)
Secondary outcome measures
Progression-free survival (Phase II)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (radiation therapy, TLR9 agonist SD-101, ibrutinib)Experimental Treatment3 Interventions
Patients undergo radiation therapy on days 1 and 2. Within 12 hours of the completion of radiation therapy, patients receive TLR9 agonist SD-101 IT on day 2 and on days 9, 16, 23, 30 and 37. Patients also receive ibrutinib PO daily beginning on day 9 for 96 weeks or in the absence of disease progression or unexpected toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2017
Completed Phase 3
~7250
Ibrutinib
2014
Completed Phase 3
~1880
TLR9 Agonist SD-101
2016
Completed Phase 2
~40
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Who is running the clinical trial?
Robert LowskyLead Sponsor
4 Previous Clinical Trials
49 Total Patients Enrolled
Janssen, LPIndustry Sponsor
160 Previous Clinical Trials
307,969 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,468 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had allergic reactions in the past to drugs similar to SD 101 or ibrutinib.You must have a visible tumor or disease that can be measured and is not located in the area being treated with radiation therapy.If you have any other medical conditions or test results that could affect your ability to take part in the study or make it harder to understand the results, you may not be able to participate.You have a serious autoimmune disease that needed treatment in the last 5 years, such as lupus, arthritis, multiple sclerosis, or other similar conditions that can cause significant health problems.You have had a stroke or bleeding in the brain within the past 6 months.You are taking blood thinners like warfarin or similar medications.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (radiation therapy, TLR9 agonist SD-101, ibrutinib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the participant count of this experiment?
"The recruitment period for this trial has concluded, with the study being first posted on November 7th 2016 and most recently updated on June 13th 2022. Patients looking to join a clinical trial may find 1722 lymphoma or mantle-cell studies are still recruiting patients as well as 155 radiation therapy trials that remain open."
Answered by AI
Are there any vacancies available in this research endeavor?
"According to clinicaltrials.gov, this experiment is no longer recruiting participants and has not been since June 13th 2022. However, there are 1,877 other studies that remain open for enrollment at the moment."
Answered by AI
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