Trial Outcomes & Findings for ALI Post Radiation Therapy in Patients With Lung and Esophageal Canter (NCT NCT04668833)
NCT ID: NCT04668833
Last Updated: 2026-05-07
Results Overview
Absolute lymphocyte counts at week 6 (+/- 14 days) - ALC measures the actual number of lymphocytes in blood, which is to assess immune system health.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
6 weeks +/- 14 days after ALI
Results posted on
2026-05-07
Participant Flow
Participant milestones
| Measure |
Autologous Lymphocyte Infusion (ALI) for Patients With Solid Tumor Malignancies After Radiation.
Autologous lymphocyte infusion (ALI) for patients with solid tumor malignancies after chemo- radiation therapy.
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.
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Autologous Lymphocyte Infusion (ALI) for Patients With Solid Tumor Malignancies After Radiation.
Autologous lymphocyte infusion (ALI) for patients with solid tumor malignancies after chemo- radiation therapy.
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.
|
|---|---|
|
Overall Study
Disease Progression
|
1
|
|
Overall Study
Per patient's request
|
3
|
Baseline Characteristics
ALI Post Radiation Therapy in Patients With Lung and Esophageal Canter
Baseline characteristics by cohort
| Measure |
Autologous Lymphocyte Infusion (ALI) for Patients With Solid Tumor Malignancies After Radiation.
n=19 Participants
Autologous lymphocyte infusion (ALI) for patients with solid tumor malignancies after chemo- radiation therapy.
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=54 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=54 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=54 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=54 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
|
Region of Enrollment
United States
|
19 Participants
n=54 Participants
|
PRIMARY outcome
Timeframe: 6 weeks +/- 14 days after ALIAbsolute lymphocyte counts at week 6 (+/- 14 days) - ALC measures the actual number of lymphocytes in blood, which is to assess immune system health.
Outcome measures
| Measure |
Autologous Lymphocyte Infusion (ALI) for Patients With Solid Tumor Malignancies After Radiation.
n=19 Participants
Autologous lymphocyte infusion (ALI) for patients with solid tumor malignancies after chemo- radiation therapy.
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.
|
|---|---|
|
To Evaluate the Absolute Lymphocyte Counts Greater or Equal to 1000 Cells/uL 6 Weeks After ALI
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline to 6 weeks1. Grades 3-5 allergic reactions related to ALI 2. Grade 3-5 organ toxicity 3. Treatment-related death
Outcome measures
| Measure |
Autologous Lymphocyte Infusion (ALI) for Patients With Solid Tumor Malignancies After Radiation.
n=19 Participants
Autologous lymphocyte infusion (ALI) for patients with solid tumor malignancies after chemo- radiation therapy.
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.
|
|---|---|
|
To Evaluate the Safety of ALI in Patients Who Had Undergone Chemoradiation.
Grade 3-5 Allergic Reaction
|
0 Participants
|
|
To Evaluate the Safety of ALI in Patients Who Had Undergone Chemoradiation.
Grade 3-5 organ toxicities
|
0 Participants
|
|
To Evaluate the Safety of ALI in Patients Who Had Undergone Chemoradiation.
Treatment related death
|
0 Participants
|
Adverse Events
Autologous Lymphocyte Infusion (ALI) for Patients With Solid Tumor Malignancies After Radiation.
Serious events: 0 serious events
Other events: 6 other events
Deaths: 9 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Autologous Lymphocyte Infusion (ALI) for Patients With Solid Tumor Malignancies After Radiation.
n=19 participants at risk
Autologous lymphocyte infusion (ALI) for patients with solid tumor malignancies after chemo- radiation therapy.
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.
|
|---|---|
|
Nervous system disorders
tremor
|
5.3%
1/19 • Number of events 1 • Baseline to 6 weeks post ALI
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
5.3%
1/19 • Number of events 1 • Baseline to 6 weeks post ALI
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.3%
1/19 • Number of events 1 • Baseline to 6 weeks post ALI
|
|
Blood and lymphatic system disorders
anemia
|
5.3%
1/19 • Number of events 1 • Baseline to 6 weeks post ALI
|
|
Immune system disorders
arthralgias
|
5.3%
1/19 • Number of events 1 • Baseline to 6 weeks post ALI
|
|
Cardiac disorders
atrial flutter
|
5.3%
1/19 • Number of events 1 • Baseline to 6 weeks post ALI
|
|
Skin and subcutaneous tissue disorders
body odor
|
5.3%
1/19 • Number of events 1 • Baseline to 6 weeks post ALI
|
|
Respiratory, thoracic and mediastinal disorders
congestion
|
5.3%
1/19 • Number of events 1 • Baseline to 6 weeks post ALI
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
10.5%
2/19 • Number of events 2 • Baseline to 6 weeks post ALI
|
|
Skin and subcutaneous tissue disorders
Diaphoresis
|
5.3%
1/19 • Number of events 1 • Baseline to 6 weeks post ALI
|
|
General disorders
fatigue
|
5.3%
1/19 • Number of events 1 • Baseline to 6 weeks post ALI
|
|
General disorders
fever
|
5.3%
1/19 • Number of events 1 • Baseline to 6 weeks post ALI
|
|
Metabolism and nutrition disorders
hyperkalemia
|
5.3%
1/19 • Number of events 1 • Baseline to 6 weeks post ALI
|
|
Nervous system disorders
numbness
|
5.3%
1/19 • Number of events 1 • Baseline to 6 weeks post ALI
|
|
Respiratory, thoracic and mediastinal disorders
Radiation pneumonitis
|
5.3%
1/19 • Number of events 1 • Baseline to 6 weeks post ALI
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
10.5%
2/19 • Number of events 2 • Baseline to 6 weeks post ALI
|
|
Psychiatric disorders
sleep disturbance
|
5.3%
1/19 • Number of events 1 • Baseline to 6 weeks post ALI
|
|
Nervous system disorders
syncope
|
5.3%
1/19 • Number of events 1 • Baseline to 6 weeks post ALI
|
|
Vascular disorders
thromboembolic event
|
5.3%
1/19 • Number of events 1 • Baseline to 6 weeks post ALI
|
Additional Information
Gheath Al-Atrash, MD/Stem Cell Transplantation Department
UT MD Anderson Cancer Center
Phone: 713-563-3324
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place