Study on Ultra Low Dose Radiation Before or After Chemotherapy-Free Targeted Therapy for Treating Relapsed or Resistant Mantle Cell Lymphoma

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04054167

Provider View

This clinical trial is exploring whether using ultra low dose radiation before or after targeted therapy without chemotherapy can help treat mantle cell lymphoma that has returned or is not responding to treatment.

Patient Parameters

Program Overview

This study is investigating how well ultra low dose radiation works when given before or after targeted therapy that does not include chemotherapy, in patients with mantle cell lymphoma that has come back or is not responding to treatment. Radiation therapy uses high-energy x-rays to kill cancer cells and shrink tumors. Ultra low dose radiation is generally associated with fewer side effects, which may allow patients to receive it more often than high-dose radiation. This trial aims to find out if ultra low dose radiation can help control mantle cell lymphoma and improve the effectiveness of targeted therapy without chemotherapy.

Description

The main goal of this study is to see if adding ultra low dose radiation (ULDR) to targeted therapy without chemotherapy can lead to a lasting response in the treated areas by measuring the overall response rate at 3 months.

Secondary goals include:

  • Checking if ULDR can improve the time patients live without the disease getting worse and their overall survival.
  • Identifying factors that might lead to worse outcomes and seeing if radiation can help overcome these factors.
  • Seeing if radiation can help patients transition to other investigational drugs by reducing the size of the disease, controlling symptoms, and maintaining good health.

In this study, patients will receive ultra low dose radiation for 1-2 days before starting targeted therapy without chemotherapy. If the treated area does not respond, patients may receive a second, longer course of radiation. After completing the study treatment, patients will have follow-up visits every 6 months for up to 5 years.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of mantle cell lymphoma with a positive tissue biopsy. Biopsy does not need to be from the area being treated.
  • Can be newly diagnosed or have previously treated mantle cell lymphoma that has returned or is resistant to treatment.
  • Must understand and voluntarily sign an informed consent form approved by the review board.
  • Must be 18 years or older at the time of signing the consent form.
  • Must have measurable disease by CT scan, with at least one lesion measuring 1.5 cm or larger. Patients with blood involvement, non-measurable disease, or disease in the gastrointestinal tract or bone marrow are also eligible.
  • Patients with disease only in the gastrointestinal tract, bone marrow, or spleen are allowed and will be analyzed separately.
  • Must have a performance status of 2 or less, meaning they are able to carry out all self-care but unable to carry out any work activities.
  • Must be willing and able to participate in all study-related procedures and therapy, including swallowing capsules without difficulty.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for 30 days after the last treatment.
  • Men must use effective contraception during the study and for 30 days after the last treatment if sexually active with a woman of childbearing potential.
  • Must have adequate liver and kidney function, and specific blood cell counts within required limits.
  • Patients with bone marrow involvement by mantle cell lymphoma are eligible if their blood counts meet specific criteria without growth factor support.

Exclusion Criteria

  • Have had previous radiation therapy to the area that would be treated, making additional radiation unsafe.
  • Have active scleroderma, lupus, or any other autoimmune disease that would increase the risk of side effects from radiation.
  • Have any serious medical condition, such as uncontrolled high blood pressure, diabetes, infection, heart disease, lung disease, kidney failure, active bleeding, or psychiatric illness, that would make participation unsafe.
  • Are pregnant or breastfeeding.
  • Have central nervous system lymphoma that needs treatment before addressing other areas.
  • If radiation would involve more than 40% of the bone marrow volume. The doctor can treat up to 40% and then wait 4-6 weeks to treat the rest, ensuring blood counts are stable.
  • If radiation would prevent participation in another phase I trial.

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