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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I have been newly diagnosed with early-stage follicular lymphoma, confirmed to be grade 1 or 2.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of patients that remain progression free, defined as progressive disease or death due to disease
Secondary outcome measures
Overall survival
Progression free survival rate

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
~1880
Radiation Therapy
2017
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,705 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,234 Total Patients Enrolled
Bouthaina S DabajaPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
265 Total Patients Enrolled

Media Library

Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT01473628 — Phase 1 & 2
Follicular Lymphoma Research Study Groups: Arm II (radiation therapy and observation), Arm I (radiation therapy and rituximab)
Follicular Lymphoma Clinical Trial 2023: Radiation Therapy Highlights & Side Effects. Trial Name: NCT01473628 — Phase 1 & 2
Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT01473628 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What kind of medical applications does Rituximab have?

"Rituximab is a viable remedy for the treatment of dlbcl and additional illnesses, such as b-cell lymphomas, polyangium, or pemphigus vulgaris."

Answered by AI

How many participants are included in the current research project?

"At this time, no new patients are being recruited for this particular trial. The opening of the study was on May 20th 2013 and it has since been updated on June 21st 2022. If you are seeking alternative trials, 1719 studies related to lymphoma, follicular are open at present with 406 trials using Rituximab still accepting participants."

Answered by AI

Is registration open for this scientific investigation?

"Unfortunately, this clinical trial is not currently seeking enrolment. Even though it was initially posted in May 2013 and last updated in June 2022, there are still 1,719 trials actively recruiting people with lymphoma who need follicular treatments as well as 406 additional trials using Rituximab that require participants."

Answered by AI
~29 spots leftby May 2027