Gentler radiation may boost lymphoma treatment without harsh side effects
NCT ID NCT04054167
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This phase II trial tests whether ultra low dose radiation, given before or after chemotherapy-free targeted therapy, can help control mantle cell lymphoma that has returned or stopped responding to treatment. About 51 adults with measurable disease will receive the radiation, and doctors will check tumor shrinkage at 3 months. The goal is to improve response while reducing side effects compared to standard high-dose radiation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ultra low dose radiation therapy
- What this could lead to
- If successful, this approach could offer a gentler way to control mantle cell lymphoma when standard treatments stop working, potentially improving quality of life.
- What could go wrong
- This is a small, early-phase trial (51 participants) with no control group, so results may not apply broadly. The radiation is ultra low dose, but its long-term effectiveness and safety are still uncertain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
51 people
The number who actually took part.
- Started
-
Jun 2019
- Expected to finish
-
Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. * Patients can be newly diagnosed or previously treated relapsed and/or refractory MCL. * Understand and voluntarily sign an IRB-approved informed consent form. * Age ≥ 18 years at the time of signing the informed consent. * Patients must have bi-dimensional measurable disease (Measurable disease by CT scan defined as at least 1 lesion that measures =/\>1.5 cm in single dimension.) Patient presenting with lesions in the presence of leukemia phase (peripheral blood involvement), non-measurable disease, gastrointestinal (GI) MCL, or bone marrow (BM) MCL are also eligible. * Gastrointestinal or bone marrow or spleen only patients are allowable and will be analyzed separately. * Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less (see Appendix 1). * Willing and able to participate in all study related procedures and therapy including swallowing capsules without difficulty. * Females of childbearing potential (FCBP)1 must have a negative serum or urine pregnancy test and must be willing to use acceptable methods of birth control during the study and for 30 days after the last dose of study treatment. * Male patients must use an effective barrier method of contraception during the study and for 30 days following the last dose of study treatment if sexually active with a female of childbearing potential. * Serum bilirubin \<1.5 mg/dl and Cr Clearance ≥ 30 mL/min, platelet count \>25,000/mm3 and absolute neutrophil count (ANC) \> 1,000/mm3, AST (SGOT) and ALT (SGPT) \< 3 x upper limit of normal or \< 5 x upper limit of normal if hepatic metastases are present. * Patients who have bone marrow infiltration by MCL are eligible if their ANC is ≥ 1000/mm3 \[growth factor not allowed\] or their platelet level is ≥ 25,000/mm3 Exclusion Criteria: * Has had prior radiation therapy to the potential radiation target such that additional radiation therapy is considered unsafe by the treating radiation oncologist * Has a diagnosis of active scleroderma or lupus or any other autoimmune disease that by the opinion of the treating radiation oncologist would put the patient at unacceptable risk of toxicity. * Any serious medical condition including but not limited to, uncontrolled hypertension, uncontrolled diabetes mellitus, uncontrolled infection, active/symptomatic coronary artery disease, COPD, renal failure, active hemorrhage, or psychiatric illness that, in the investigators opinion places the patient at unacceptable risk and would prevent the subject from signing the informed consent form. * Pregnant or breast-feeding females. * All patients with central nervous system lymphoma that needs attention prior to treatment of the lesions. * If the total fields of radiation will include a marrow volume of more than 40%. Physician can include as many fields to respect the 40 % of marrow volume and come back in 4-6 weeks later to address the rest of the disease after insuring that the Blood counts are adequate. Blood counts should be back to back to the numbers prior to starting the first phase of radiation +- 10% variance. * If given radiation prevent them from going through an alternative phase I trial
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
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