Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT04054167

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

Led by M.D. Anderson Cancer Center · Updated on 2025-12-23

80

Participants Needed

1

Research Sites

446 weeks

Total Duration

On this page

Sponsors

M

M.D. Anderson Cancer Center

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed mantle cell lymphoma diagnosed by tissue biopsy
  • Newly diagnosed or previously treated relapsed or refractory mantle cell lymphoma
  • Age 18 years or older
  • Measurable disease with at least one lesion 1.5 cm or larger, or presence of leukemia phase, gastrointestinal, bone marrow, or spleen involvement
  • Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
  • Able and willing to participate in all study procedures and take capsules
  • Females of childbearing potential must have a negative pregnancy test and agree to use birth control during the study and for 30 days after last treatment
  • Male patients must use effective contraception during the study and for 30 days after last treatment if sexually active with females of childbearing potential
  • Adequate blood counts and liver and kidney function as defined by study criteria
  • Bone marrow infiltration patients eligible if neutrophil and platelet counts meet study thresholds
Not Eligible

You will not qualify if you...

  • Prior radiation therapy to the planned radiation site considered unsafe for additional radiation
  • Active scleroderma, lupus, or other autoimmune diseases posing unacceptable risk
  • Serious uncontrolled medical conditions including hypertension, diabetes, infection, coronary artery disease, COPD, renal failure, active bleeding, or psychiatric illness
  • Pregnant or breastfeeding females
  • Central nervous system lymphoma requiring treatment before study
  • Radiation fields involving more than 40% of bone marrow volume
  • Radiation preventing participation in an alternative phase I trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

B

Bouthaina S Dabaja

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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