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Low Dose Radiation Therapy for Mantle Cell Lymphoma

Phase 2
Recruiting
Led By Bouthaina S Dabaja
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less.
Patients must have demonstrated progressive disease on positron emission tomography (PET)/computed tomography (CT) imaging following ibrutinib treatment, mono- or combinatorial therapy, in the relapsed/refractory setting.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

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.

Who is the study for?
This trial is for patients with mantle cell lymphoma that has returned or isn't responding to treatment. They must have had at least two prior therapies, be in a stable condition (ECOG performance status of 2 or less), and have measurable disease. Women must not be pregnant and agree to birth control measures; men also need to use contraception if with a partner who can bear children.Check my eligibility
What is being tested?
The study is testing ultra low dose radiation therapy before or after targeted therapy without chemotherapy in patients with relapsed/refractory mantle cell lymphoma. The goal is to see if this approach helps control the cancer better and improves responses compared to standard treatments.See study design
What are the potential side effects?
Ultra low dose radiation may cause fewer side effects than high-dose radiation, but risks could include skin irritation, fatigue, mild nausea, and potential impacts on blood counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can do most of my daily activities on my own.
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My cancer has worsened after treatment with ibrutinib, shown by PET/CT scans.
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My cancer affects only my gastrointestinal tract, bone marrow, or spleen.
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I have been diagnosed with mantle cell lymphoma confirmed by a tissue biopsy.
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I have had at least 2 treatments for my mantle cell lymphoma, including specific medications or a stem cell transplant.
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I have been diagnosed with mantle cell lymphoma confirmed by a tissue biopsy.
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My cancer has worsened after treatment with ibrutinib, shown by PET/CT scans.
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I can do most of my daily activities on my own.
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I have a tumor that is at least 1.5 cm large, or I have cancer affecting my blood, GI tract, or bone marrow.
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I can take part in all study activities and can swallow pills without trouble.
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I am able to have children, not pregnant, and will use birth control during and 30 days after the study.
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I will use effective birth control during and for 30 days after the study if I'm sexually active.
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My kidneys are functioning well enough to clear waste.
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My white blood cell count is above 1000 and my platelet count is above 25,000.
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My kidneys are functioning well enough to clear waste.
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My white blood cell count is above 1000 and my platelet count is above 25,000.

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
Overall response rate (ORR)
Secondary outcome measures
ATM mutational status
Overall survival
PET/CT metabolic parameters
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (ultra low dose radiation therapy)Experimental Treatment1 Intervention
Patients undergo ultra low dose radiation for 1-2 days before chemotherapy free-targeted therapy. Patients may receive a second, longer course of radiation if the lesion treated does not respond.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,267 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,285 Total Patients Enrolled
Bouthaina S DabajaPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
315 Total Patients Enrolled

Media Library

Low Dose Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04054167 — Phase 2
Mantle Cell Lymphoma Research Study Groups: Treatment (ultra low dose radiation therapy)
Mantle Cell Lymphoma Clinical Trial 2023: Low Dose Radiation Therapy Highlights & Side Effects. Trial Name: NCT04054167 — Phase 2
Low Dose Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04054167 — Phase 2

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~22 spots leftby Dec 2025