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Low Dose Radiation Therapy for Mantle Cell Lymphoma
Study Summary
This trial is testing how well ultra low dose radiation works before or after targeted therapy in treating patients with mantle cell lymphoma that has come back or does not respond to treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have an autoimmune disease that could make cancer treatment too risky.My cancer has worsened after treatment with ibrutinib, shown by PET/CT scans.I do not have any serious health conditions that my doctor thinks could make this study unsafe for me.My cancer affects only my gastrointestinal tract, bone marrow, or spleen.I've had radiation before where they now want to target, and more is unsafe.I can take part in all study activities and can swallow pills without trouble.I have been diagnosed with mantle cell lymphoma confirmed by a tissue biopsy.I have had at least 2 treatments for my mantle cell lymphoma, including specific medications or a stem cell transplant.I can do most of my daily activities on my own.My cancer affects only my gastrointestinal tract, bone marrow, or spleen.I have been diagnosed with mantle cell lymphoma confirmed by a tissue biopsy.I have had at least 2 treatments for my mantle cell lymphoma, including specific medications or a stem cell transplant.My cancer has worsened after treatment with ibrutinib, shown by PET/CT scans.I can do most of my daily activities on my own.I have a tumor that is at least 1.5 cm large, or I have cancer affecting my blood, GI tract, or bone marrow.I can take part in all study activities and can swallow pills without trouble.I am able to have children, not pregnant, and will use birth control during and 30 days after the study.I will use effective birth control during and for 30 days after the study if I'm sexually active.My kidneys are functioning well enough to clear waste.My white blood cell count is above 1000 and my platelet count is above 25,000.My kidneys are functioning well enough to clear waste.My white blood cell count is above 1000 and my platelet count is above 25,000.My brain lymphoma needs treatment before any other cancer treatments.I am considering a CAR T cell trial instead of radiation.My radiation treatment will not exceed 40% of my bone marrow volume at one time.
- Group 1: Treatment (ultra low dose radiation therapy)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Are there any open positions for participants in this trial?
"That is correct, the website shows that this research is looking for 80 individuals to take part and is currently recruiting at 1 site. The study was first advertised on 6/14/2019 with the most recent update being 9/22/2022."
How many guinea pigs are they taking for this study?
"That is correct. The listing on clinicaltrials.gov currently says that this study is open for recruitment and 80 patients are needed from 1 site. This trial was first posted on 6/14/2019 and has had updates made as recently as 9/22/2022."
Do the risks of Low Dose Radiation Therapy outweigh the benefits?
"While there is some data supporting the safety of low dose radiation therapy, as this is only a phase 2 trial, there is none yet to support its efficacy."
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