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Radiation Therapy + Rituximab for Follicular Lymphoma

Phase 1 & 2

Recruiting

Led By Bouthaina S Dabaja

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Newly diagnosed patients with stage I and II follicular lymphoma, pathologically confirmed at MD Anderson Cancer Center (MDACC) to be grade 1 or 2

Be older than 18 years old

Must not have

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 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how well radiation therapy and rituximab work in treating patients with early stage follicular lymphoma.

Who is the study for?

This trial is for newly diagnosed patients with early-stage (I-II) grade 1 or 2 follicular lymphoma. Participants must have certain blood cell counts, good performance status, and proper liver and kidney function. Men must use contraception; women must be postmenopausal, surgically sterilized, or using two barrier methods of contraception.

What is being tested?

The study tests the combination of radiation therapy with rituximab against cancer cells in patients with follicular lymphoma. Radiation aims to kill cancer cells directly while rituximab is an antibody that may help the immune system fight cancer.

What are the potential side effects?

Possible side effects include reactions to rituximab like fever and chills, risk of infection due to a weakened immune system, fatigue from radiation therapy, as well as potential damage to nearby organs or tissues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been newly diagnosed with early-stage follicular lymphoma, confirmed to be grade 1 or 2.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have serious heart problems that need ongoing treatment.

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I've had radiation to the same area where my current cancer is, and can't have more without risking harm.

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I have an active hepatitis B or C infection.

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I am currently using alternative or complementary medicines.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of patients that remain progression free, defined as progressive disease or death due to disease

Secondary study objectives

Overall survival

Progression free survival rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (radiation therapy and observation)Experimental Treatment2 Interventions

Patients undergo radiation therapy five days a week for 2.5 weeks and then undergo observation.

Group II: Arm I (radiation therapy and rituximab)Experimental Treatment2 Interventions

Patients undergo radiation therapy five days a week for 2.5 weeks (12 treatments) and receive rituximab IV over 4-6 hours weekly with the start of radiation for 4 weeks and then every 2 months for up to 4 additional doses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituximab

1999

Completed Phase 4

~2990

Radiation Therapy

2017

Completed Phase 3

~7250