ALI Post Radiation Therapy in Patients With Lung and Esophageal Canter

NCT04668833 | Terminated Phase 2

• 2 other identifiers: 2019-1164NCI-2020-07836
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Solid Tumor Malignancies

Outcome Measures

Primary Outcomes (1)

• To evaluate the absolute lymphocyte counts in lung and esophageal cancer patients who had undergone chemoradiation. (CRT)

  The primary outcome is the change between the two measures, i.e., absolute lymphocyte counts at week 6 (+/- 14 days) minus baseline ALC, referred as ALC change. Recently, we reviewed 755 patients with stage I-III esophageal carcinoma who received concurrent CRT with or without surgery in 2004-2015 \[1\]. The means of the absolute lymphocyte counts were 1,570 cells/µL (SD=610) and 980 cells/µL (SD=600) at based line and at the first follow-up visit post-CRT, respectively. We incorporate this clinical evidence in our sample size justification.

  Baseline to 6 weeks

Secondary Outcomes (2)

• To evaluate the feasibility of ALI in patients who had undergone chemoradiation.

  Baseline to 6 weeks

• To evaluate the safety of ALI in patients who had undergone chemoradiation.

  Baseline to 6 weeks

Study Arms (1)

Treatment (Autologous Lymphocyte Infusions)

EXPERIMENTAL

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.

Procedure: Autologous lymphocyte infusion (ALI)

Interventions

Autologous lymphocyte infusion (ALI) PROCEDURE

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.

Treatment (Autologous Lymphocyte Infusions)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically documented NSCLC or esophageal cancers Stage II-IVA disease where definitive chemoradiation is the standard of care Age 18

You may not qualify if:

• Prior radiotherapy to the chest Life expectancy\<6 months Any systemic therapy, aside from standard of care immunotherapy, that is planned to be administered prior to 6 weeks after ALI. Pregnancy

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77090, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

Study Officials

• Gheath Al-Atrash

  MD Anderson Cancer Center, Houston, Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 16, 2020
• Study Start: September 29, 2020
• Primary Completion: October 24, 2025
• Study Completion: October 24, 2025
• Last Updated: October 31, 2025

Record last verified: 2025-10

Locations

US (1)