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ALI Post Radiation Therapy for Thoracic Cancers

Phase 2
Waitlist Available
Led By Gheath Al-Atrash
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
Histologically or cytologically documented NSCLC or esophageal cancers Stage II-IVA disease where definitive chemoradiation is the standard of care
Age 18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 6 weeks
Awards & highlights

Study Summary

This trial is testing if giving patients their own lymphocytes (a type of white blood cell) after chemotherapy and radiation treatment for lung or esophageal cancer is safe and effective.

Who is the study for?
This trial is for adults over 18 with non-small cell lung cancer or esophageal cancer at stages II-IVA, where chemoradiation is standard. Participants must not have had prior chest radiotherapy, any systemic therapy other than standard immunotherapy before 6 weeks after ALI, be pregnant, or have a life expectancy under 6 months.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of autologous lymphocyte infusion (ALI) in patients receiving chemotherapy and radiation for lung or esophageal cancer. It aims to understand if this approach improves treatment outcomes.See study design
What are the potential side effects?
While specific side effects are not listed here, treatments like ALI may cause immune reactions, fatigue, infection risk increase due to immune system changes from infusions alongside typical chemotherapy and radiation side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My lung or esophageal cancer is at a stage where combined chemotherapy and radiation is recommended.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To evaluate the absolute lymphocyte counts in lung and esophageal cancer patients who had undergone chemoradiation. (CRT)
Secondary outcome measures
To evaluate the feasibility of ALI in patients who had undergone chemoradiation.
To evaluate the safety of ALI in patients who had undergone chemoradiation.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (Autologous Lymphocyte Infusions)Experimental Treatment1 Intervention
The purpose of this study is to determine the safety and preliminary efficacy of un-manipulated autologous lymphocyte infusion (ALI) using the patient's own lymphocytes collected using apheresis, and infused after the completion of radiation/chemoradiation.

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,756 Total Patients Enrolled
Gheath Al-AtrashPrincipal InvestigatorMD Anderson Cancer Center, Houston, Texas
2 Previous Clinical Trials
30 Total Patients Enrolled

Media Library

Autologous lymphocyte infusion (ALI) Clinical Trial Eligibility Overview. Trial Name: NCT04668833 — Phase 2
Solid Tumor Cancers Research Study Groups: Treatment (Autologous Lymphocyte Infusions)
Solid Tumor Cancers Clinical Trial 2023: Autologous lymphocyte infusion (ALI) Highlights & Side Effects. Trial Name: NCT04668833 — Phase 2
Autologous lymphocyte infusion (ALI) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04668833 — Phase 2

Frequently Asked Questions

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

How many human subjects are participating in this research?

"The clinical trial is currently ongoing and recruiting patients at one location. 20 participants are needed in total. The trial was originally posted on September 29th, 2020 and was most recently edited on July 14th, 2022."

Answered by AI

Are people with the conditions necessary to participate in this research able to sign up at this time?

"The study, which is presently recruiting patients, was originally posted on clinicaltrials.gov on September 29th 2020. The 7/14/2022 update was the most recent at the time of writing."

Answered by AI

What is the likelihood of negative side effects from Autologous lymphocyte infusion (ALI)?

"Autologous lymphocyte infusion (ALI) has some evidence backing its safety, but none for efficacy. Therefore, it was given a score of 2."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
ALI Post Radiation Therapy in Patients With Lung and Esophageal Canter
2020. "ALI Post Radiation Therapy in Patients With Lung and Esophageal Canter". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04668833.
~11 spots leftby Feb 2027
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