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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

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.

Patients must have a confirmed diagnosis of mantle cell lymphoma with positivity in tissue biopsy. Biopsy does not need to be done of the lesions to be treated.

Must not have

Has had prior radiation therapy to the potential radiation target such that additional radiation therapy is considered unsafe by the treating radiation oncologist.

All patients with central nervous system lymphoma that needs attention prior to treatment of the lesions.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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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My cancer has worsened after treatment with ibrutinib, shown by PET/CT scans.

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I have been diagnosed with mantle cell lymphoma confirmed by a tissue biopsy.

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I can do most of my daily activities on my own.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I've had radiation before where they now want to target, and more is unsafe.

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My brain lymphoma needs treatment before any other cancer treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall response rate (ORR)

Secondary study objectives

ATM mutational status

Overall survival

PET/CT metabolic parameters

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 7Eligibility criteria met