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NCT04054167

Ultra Low Dose Radiation Delivered Before or After Chemotherapy-Free Targeted Therapy in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma

Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~51 participants
Updated 2026-06-03 on ClinicalTrials.gov
What's tested:Low Dose Radiation Therapy

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall response rate (ORR)
Measured over At 3 months

Conditions

Recurrent Mantle Cell Lymphoma
Refractory Mantle Cell Lymphoma

Explore related trials

Mantle Cell Lymphoma

NCT04054167

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • M D Anderson Cancer Center

    Houston, Texasno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Bouthaina S Dabaja · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Overall response rate (ORR)At 3 months

    ORR will be based on the tumors residing within the radiated field using the sum of the longest tumoral axes treated. Responses are defined as follows: i) complete response (CR): \> 75% reduction in the sum of the longest tumoral axes treated within a radiation field; ii) partial response (PR): 50 to 75% reduction; and stable disease (SD): a reduction \< 50%. Progressive disease will be defined as any relative increase in the sum of the longest tumoral axes within the radiated field. ORR will be assessed by positron emission tomography (PET)/computed tomography (CT) at 3-months after the conclusion of ultra low dose radiation (ULDR). The Lugano Classification will be used to assess tumor response. Will estimate ORR at 3 months by providing an exact 95% confidence interval for the evaluable study population.