NCT04668833

ALI Post Radiation Therapy in Patients With Lung and Esophageal Canter

Phase II Study of Autologous Lymphocyte Infusions After Radiation Therapy to Mitigate Radiation Induced Lymphopenia and Enhance Immune Reconstitution in Patients With Solid Tumor Malignancies

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical research study is to learn if giving autologous lymphocyte infusions to patients who are receiving chemotherapy and radiation for non-small cell lung cancer or esophageal cancer is safe and effective.

Detailed description

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. Primary Objective To investigate the preliminary efficacy of autologous lymphocyte infusion (ALI) in improving the absolute lymphocyte counts in lung and esophageal cancer patients who had undergone chemo-radiation (CRT). Secondary Objectives 1. To evaluate the feasibility and safety of ALI in patients who had undergone chemoradiation. 2. To identify lymphocyte clonal populations in the tissue that are specific for tumor cells 3. To identify immune reconstitution in the peripheral blood shaped by ALI. 4. To conduct clonal analysis using T-cell receptor (TCR) sequencing from tumor and from peripheral blood.

Conditions

• Solid Tumor Malignancies

Interventions

Type	Name	Description
PROCEDURE	Autologous lymphocyte infusion (ALI)	On the day after completing the last dose of radiation therapy, the patient will have an appointment scheduled in the Apheresis Unit for the infusion of unmunipulated cryopreserved cells. Patients will be pre medicated with acetaminophen (325-650 mg PO) and diphenhydramine (12.5-25 mg PO or IV) prior to infusion. Cells will be infused without a leukoreduction filter at a rate determined by cell volume.

Timeline

• Start date: 2020-09-29
• Primary completion: 2025-10-24
• Completion: 2025-10-24
• First posted: 2020-12-16
• Last updated: 2025-10-31

Locations

1 site across 1 country: United States