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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-07836 | Other Identifier | Clinical Trials Reporting Program (CTRP) | |
| 1R21CA240881 | U.S. NIH Grant/Contract | View source |
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<75% participation
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To Evaluate the Absolute Lymphocyte Counts Greater or Equal to 1000 Cells/uL 6 Weeks After ALI | Absolute lymphocyte counts at week 6 (+/- 14 days) - ALC measures the actual number of lymphocytes in blood, which is to assess immune system health. | 6 weeks +/- 14 days after ALI |
| Measure | Description | Time Frame |
|---|---|---|
| To Evaluate the Safety of ALI in Patients Who Had Undergone Chemoradiation. |
| Baseline to 6 weeks |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Gheath Al-Atrash | MD Anderson Cancer Center, Houston, Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77090 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | To Evaluate the Absolute Lymphocyte Counts Greater or Equal to 1000 Cells/uL 6 Weeks After ALI | Absolute lymphocyte counts at week 6 (+/- 14 days) - ALC measures the actual number of lymphocytes in blood, which is to assess immune system health. | Posted | Count of Participants | Participants | 6 weeks +/- 14 days after ALI |
|
Baseline to 6 weeks post ALI
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gheath Al-Atrash, MD/Stem Cell Transplantation Department | UT MD Anderson Cancer Center | 713-563-3324 | galatras@mdanderson.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 16, 2023 | Apr 1, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 17, 2023 | Oct 23, 2024 | ICF_000.pdf |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | To Evaluate the Safety of ALI in Patients Who Had Undergone Chemoradiation. |
| Posted | Count of Participants | Participants | Baseline to 6 weeks |
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| 9 |
| 19 |
| 0 |
| 19 |
| 6 |
| 19 |
| arthralgias | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
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| atrial flutter | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
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| body odor | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Diaphoresis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
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| fever | General disorders | CTCAE (4.0) | Systematic Assessment |
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| hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| numbness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Radiation pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| sleep disturbance | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
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| syncope | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| thromboembolic event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
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| tremor | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Voice alteration | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Measurements |
|---|---|
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