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Can adding a targeted antibody to radiation keep lymphoma away?

NCT ID NCT01473628

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 13, 2026 · Updated 3 times

Summary

This study looks at whether adding the drug rituximab to standard radiation therapy helps people with early-stage follicular lymphoma stay cancer-free longer. About 81 patients with stage I or II low-grade lymphoma are being randomly assigned to get radiation alone or radiation plus rituximab. The goal is to see if the combination improves progression-free survival without major side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Rituximab (a monoclonal antibody that helps the immune system attack cancer cells)
What this could lead to
If it works, this could improve the chance of keeping early-stage follicular lymphoma from coming back after radiation therapy.
What could go wrong
This is an early-phase trial with only 81 participants, so results may not be definitive. Adding rituximab may increase side effects without guaranteeing better outcomes.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

81 people

The number who actually took part.

Started

May 2013

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Newly diagnosed patients with stage I and II follicular lymphoma, pathologically confirmed at MD Anderson Cancer Center (MDACC) to be grade 1 or 2 * Prophylactic use of lamivudine in patients that have antibody positive (+), but no active infection will be up to the treating physician * Absolute neutrophil count (ANC) \>= 1000/mm\^3; this value must be obtained within four weeks before protocol entry * Platelets \>= 80,000/mm\^3; this value must be obtained within four weeks before protocol entry * Hemoglobin \>= 8 g/dL; this value must be obtained within four weeks before protocol entry * Bilirubin =\< 1.5 times the upper limit of normal (ULN); this value must be obtained within four weeks before protocol entry * Alanine aminotransferase (ALT) =\< 2 times the ULN or aspartate aminotransferase (AST) =\< 2 times the ULN; these values must be obtained within four weeks before protocol entry * Performance status \>= 2 * Patients are required to have adequate renal function as indicated by a serum creatinine =\< 2.5 mg/dL; this value must be obtained within four weeks before protocol entry * No prior known allergic reaction to monoclonal antibodies * Male patients must agree to use a barrier method of contraception or agree to abstain from heterosexual activity for the duration of the study * Female patients must be willing to use two adequate barrier methods of contraception to prevent pregnancy or agree to abstain from heterosexual activity throughout the study or be post menopausal (free from menses \> two years or surgically sterilized) * Female patients of childbearing potential must have a negative serum pregnancy test (beta human chorionic gonadotropin \[B HCG\]) within 72 hours of receiving the first dose of rituximab * Patients must have the ability able to give informed consent Exclusion Criteria: * Patients with active hepatitis B and/or hepatitis C infection * Patients with known human immunodeficiency virus (HIV) infection * Patients with active infections requiring specific anti-infective therapy are not eligible until all signs of infections are resolved * Patients who had previous radiation dose to the site of the current primary disease, which would lead to violation of known radiation tolerance limit of that particular site if treated again * Patients with pre-existing cardiovascular disease requiring ongoing treatment; this includes: congestive heart failure III/IV as defined by New York Heart Association (NYHA); uncontrolled cardiac arrhythmia; unstable angina pectoris; and recent myocardial infarction (MI) (within 6 months) * Patients who are pregnant or breast-feeding * Patient with concurrent use of complementary or alternative medicines * Patients with psychiatric illness and/or social situations that would limit compliance with the study medication and requirements

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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

  • M D Anderson Cancer Center

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.