Clinical trial · Interventional
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
NCT04668833CI-TRIAL-00110706terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): \<75% participation
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous lymphocyte infusion (ALI) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (Autologous Lymphocyte Infusions)
- 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.
- interventionNames
- Procedure: Autologous lymphocyte infusion (ALI)
Primary outcomes (1)
- measure
- To Evaluate the Absolute Lymphocyte Counts Greater or Equal to 1000 Cells/uL 6 Weeks After ALI
- timeFrame
- 6 weeks +/- 14 days after ALI
- description
- Absolute lymphocyte counts at week 6 (+/- 14 days) - ALC measures the actual number of lymphocytes in blood, which is to assess immune system health.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Histologically or cytologically documented NSCLC or esophageal cancers Stage II-IVA disease where definitive chemoradiation is the standard of care Age 18 Exclusion Criteria: 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
References
Publications (0)
Data not yet available
No reference posted for this study.