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Recurrent Mantle Cell LymphomaPhase 2NCT04054167

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

A Phase 2 study testing Low Dose Radiation Therapy in people with Recurrent Mantle Cell Lymphoma and Refractory Mantle Cell Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This phase II trial studies how well ultra low dose radiation works before or after chemotherapy-free targeted therapy in treating patients with mantle cell lymphoma that has come back or does not respond to treatment. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Low Dose Radiation Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 siteUnited States
Study dates
14 Jun 2019to 31 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 12Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Phase II Trial to Assess the Efficacy of Ultra Low Radiation Dose Delivered Prior or After Chemotherapy Free Targeted Therapy for the Treatment of Relapsed/Refractory Mantle Cell Lymphoma

This phase II trial studies how well ultra low dose radiation works before or after chemotherapy-free targeted therapy in treating patients with mantle cell lymphoma that has come back or does not respond to treatment. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. Ultra low dose radiation is generally associated with a lower risk of side effects which may allow patients to be able to receive low-dose radiation therapy more often than high-dose radiation therapy. This trial may help doctors learn if giving ultra low dose radiation helps control mantle cell lymphoma and improves response to chemotherapy free targeted therapy.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the efficacy of adding ultra low dose radiation (ULDR) to chemotherapy free-targeted therapy (CTFTT) in contributing to a durable overall response in treated locations by estimating overall response rate (ORR) at 3 months.

SECONDARY OBJECTIVES:

  1. To evaluate if ULDR can improve progression-free survival and overall survival.

II. To evaluate the prognostic factors associated with inferior progression-free survival, including patient related and previous treatment related and if radiation can overcome these prognostic factors.

III. To evaluate if radiation helps to bridge patients to other investigational drugs, by decreasing the disease bulk, controlling their symptoms, and maintaining a good performance status.

OUTLINE:

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.

After completion of study treatment, patients are followed up every 6 months for up to 5 years.

Being tested
Low Dose Radiation Therapy
Medical subject headings
Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low Dose Radiation TherapyDrug

    Also called Low Dose Radiation

    Undergo ultra low dose radiation

Study groups in NCT04054167
Study groupRoleWhat they receive
Treatment (ultra low dose radiation therapy)ExperimentalPatients 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.
Receives: Drug: Low Dose Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate (ORR)

    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.

    Measured: At 3 months

Secondary outcomes (8)

  1. Progression-free survival (PFS)

    Will be estimated at select time points of interest using the Kaplan-Meier method for all patients enrolled in the study. The origination point for time will begin at the inception of ULDR. Cox proportional hazards regression will be used to evaluate potential prognostic factors.

    Measured: From the start of ULDR treatment to the time of a progression or death, assessed up to 5 years

  2. Overall survival

    Will be estimated at select time points of interest using the Kaplan-Meier method for all patients enrolled in the study. The origination point for time will begin at the inception of ULDR. Cox proportional hazards regression will be used to evaluate potential prognostic factors.

    Measured: From the start of ULDR treatment to the time of death or loss to follow-up, assessed up to 5 years

  3. ATM mutational status

    Logistic regression will be utilized to assess the effect of patient characteristics such as ATM mutational status, on the Overall Response Rate(ORR ).

    Measured: At 3 months

  4. PET/CT metabolic parameters

    Logistic regression will be utilized to assess the effect of patient characteristics such PET/CT metabolic parameters, on the Overall Response Rate (ORR).

    Measured: At 3 months

  5. The Descriptive Statistics of Patient Characteristics of the Transitions to other Investigational Drugs.

    Will be used to summarize patient characteristics such as transitions to other investigational drugs at select time points in a patient's follow-up domain. These summaries will indicate if ULDR helps to bridge patients to other investigational drugs, by decreasing the disease bulk, controlling their symptoms, and maintaining a good performance status.

    Measured: Up to 5 years

  6. The Descriptive Statistics of Patient Characteristics of the Patients Disease Bulk.

    Will be used to summarize patient characteristics such as disease bulk at select time points in a patient's follow-up domain. These summaries will indicate if ULDR helps to bridge patients to other investigational drugs, by decreasing the disease bulk, controlling their symptoms, and maintaining a good performance status.

    Measured: Up to 5 years

  7. The Descriptive Statistics of Patient Characteristics of the Patients Symptoms.

    Will be used to summarize patient characteristics such as symptoms at select time points in a patient's follow-up domain. These summaries will indicate if ULDR helps to bridge patients to other investigational drugs, by decreasing the disease bulk, controlling their symptoms, and maintaining a good performance status.

    Measured: Up to 5 years

  8. The Descriptive Statistics of Patient Characteristics of the Patients Performance status

    Will be used to summarize patient characteristics such as performance status at select time points in a patient's follow-up domain. These summaries will indicate if ULDR helps to bridge patients to other investigational drugs, by decreasing the disease bulk, controlling their symptoms, and maintaining a good performance status.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2019
  2. Study start14 Jun 2019
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04054167
Sponsor's protocol ID
2018-0348
Other IDs
NCI-2019-01729, 2018-0348
Status last verified
May 2026
First submitted
2 Jul 2019
Last updated
3 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Low Dose Radiation Therapy in people with Recurrent Mantle Cell Lymphoma and Refractory Mantle Cell Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (ORR) (time frame: At 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04054167.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.

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