Trial · NCT04438382
Infliximab and Intravenous Immunoglobulin Therapy in Treating Patients With Steroid-Refractory Pneumonitis
NCT04438382, Phase 2, Terminated, ECOG-ACRIN Cancer Research Group; results first posted 2024-03-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Infliximab and Intravenous Immunoglobulin Therapy in Treating Patients With Steroid-Refractory Pneumonitis. Trials, record NCT04438382. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04438382
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Infliximab and Intravenous Immunoglobulin Therapy in Treating Patients With Steroid-Refractory Pneumonitis
- NCT number
- NCT04438382
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 1 participants, actual
- Lead sponsor
- ECOG-ACRIN Cancer Research Group
- Conditions
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Steroid-Refractory Pneumonitis
- Interventions
- Infliximab, Intravenous Immunoglobulin Therapy, Prednisone, Methylprednisolone
- First posted
- 2020-06-18
- Last updated
- 2026-09-29
- Results first posted
- 2024-03-26
- Limitations and caveats
- Only one patient was enrolled on this study. Due to the concern on confidentiality, individual data was not reported.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pneumonitis Response Rate | At day 28 | Pneumonitis response will be defined as an improvement in partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) of \>= 20% measured by PaO2 and recording of the FiO2 received by the patient at the time of the arterial blood gas assessment, on day 28 compared with day 1. |
| Secondary | Proportion of Patients With Radiologic Response for Steroid-refractory Pneumonitis | At days 1, 14, and 28 | Radiologic features of steroid-refractory pneumonitis will be assessed by percentage lung parenchyma involved, percentage of ground-glass opacity in lung parenchyma, and lung volume on computed tomography. The pneumonitis and lung volume will be graded "Definitely decreased", "Probably decreased", "No significant change", "Probably increased" and "Definitely increased". Response to study therapy will be defined by combining the categories "Definitely decreased" and "Probably decreased". |
| Secondary | Functional Parameters of Steroid-refractory Pneumonitis by Spirometry | At days 1, 14, and 28 | Functional features of pneumonitis will be assessed by spirometry (forced vital capacity, forced expiratory volume in one second). These quantitative measures will be reported descriptively (by median, mean, and range) by timepoints and treatment arms. |
| Secondary | Functional Parameters of Steroid-refractory Pneumonitis by Diffusion Capacity | At days 1, 14, and 28 | Functional features of pneumonitis will be assessed by diffusion capacity of the lung. These quantitative measures will be reported descriptively (by median, mean, and range) by timepoints and treatment arms. |
| Secondary | Functional Parameters of Steroid-refractory Pneumonitis by Oxygen Saturation | At days 1, 14, and 28 | Functional features of pneumonitis will be assessed by oxygen saturation on room air at rest, collected as part of the vital signs. These quantitative measures will be reported descriptively (by median, mean, and range) by timepoints and treatment arms. |
| Secondary | Number of Deaths Within 28 Days | Up to 28 days | Death reported in the 28-day period will be tabulated by treatment arm, and classified as pneumonitis-related, immunosuppression related, disease-related or other. |
| Secondary | Incidence of Adverse Events | Up to 28 days | Will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The number and severity of treatment-related adverse events from infections in any organ system by the CTCAE reported in the 28-day period after additional immunosuppression. |
| Secondary | Total Score of Functional Assessment of Cancer Therapy - Lung Version 4 | At days 1, 14, and 28 | Patient-reported outcomes of steroid-refractory pneumonitis will be measured by questionnaires (Functional Assessment of Cancer Therapy - Lung version 4 \[FACT-L\]). FACT-L consists of 5 subscales and the total score is calculated by summing the scores of the 36 items. The score ranges between 0 and 136. The higher the score, the better the quality of life. |
| Other | Distribution of Biomarkers in Patients Who Develop Steroid-refractory Pneumonitis | Days 1, 14 and 28 after study treatment | Potential blood/serum biomarkers for pneumonitis will be assessed from serially collected blood/serum in accrued patients (on Days 1, 14 and 28 after study treatment) and controls, whose blood/serum will be obtained as part of a parallel tissue-collection protocol. |
| Other | To Evaluate Associations Between Pneumonitis and Autoantibodies, T Cell Expansion, and Baseline Cytokines in the Blood | On days 1, 14, and 28 post-treatment | To evaluate associations between pneumonitis and autoantibodies, T cell expansion, and baseline cytokines in the blood. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pneumonitis Response Rate | At day 28 | Only one patient was enrolled on this study. Due to confidentiality reasons, individual data was not reported. | ||
| SECONDARY | Proportion of Patients With Radiologic Response for Steroid-refractory Pneumonitis | At days 1, 14, and 28 | Only one patient was enrolled so individual data won't be reported due to confidentiality reasons. | ||
| SECONDARY | Functional Parameters of Steroid-refractory Pneumonitis by Spirometry | At days 1, 14, and 28 | Only one patient was enrolled, so individual data won't be reported due to confidentiality reasons. | ||
| SECONDARY | Functional Parameters of Steroid-refractory Pneumonitis by Diffusion Capacity | At days 1, 14, and 28 | Only one patient was enrolled so individual data won't be reported due to confidentiality reasons. | ||
| SECONDARY | Functional Parameters of Steroid-refractory Pneumonitis by Oxygen Saturation | At days 1, 14, and 28 | Only one patient was enrolled so individual data won't be reported due to confidentiality reasons. | ||
| SECONDARY | Number of Deaths Within 28 Days | Up to 28 days | Only one patient was enrolled so individual data won't be reported due to confidentiality reasons. | ||
| SECONDARY | Incidence of Adverse Events | Up to 28 days | Only one patient was enrolled so individual data won't be reported due to confidentiality reasons. | ||
| SECONDARY | Total Score of Functional Assessment of Cancer Therapy - Lung Version 4 | At days 1, 14, and 28 | Only one patient was enrolled, so individual data won't be reported due to confidentiality reasons. | ||
| OTHER_PRE_SPECIFIED | Distribution of Biomarkers in Patients Who Develop Steroid-refractory Pneumonitis | Days 1, 14 and 28 after study treatment | |||
| OTHER_PRE_SPECIFIED | To Evaluate Associations Between Pneumonitis and Autoantibodies, T Cell Expansion, and Baseline Cytokines in the Blood | On days 1, 14, and 28 post-treatment |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A (Infliximab) | 0 | |
| Overall Study | STARTED | Arm B (Intravenous Immunoglobulin Therapy) | 1 | |
| Overall Study | COMPLETED | Arm A (Infliximab) | 0 | |
| Overall Study | COMPLETED | Arm B (Intravenous Immunoglobulin Therapy) | 1 | |
| Overall Study | NOT COMPLETED | Arm A (Infliximab) | 0 | |
| Overall Study | NOT COMPLETED | Arm B (Intravenous Immunoglobulin Therapy) | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A (Infliximab) | 0 | 0 |
| Total, all-cause mortality | Arm B (Intravenous Immunoglobulin Therapy) | 0 | 1 |
| Total, other adverse events | Arm A (Infliximab) | 0 | 0 |
| Total, other adverse events | Arm B (Intravenous Immunoglobulin Therapy) | 0 | 0 |
| Total, serious adverse events | Arm A (Infliximab) | 0 | 0 |
| Total, serious adverse events | Arm B (Intravenous Immunoglobulin Therapy) | 0 | 0 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33568350 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UG1CA189828 | ECOG-ACRIN NCORP Research Base | WAGNER, LYNNE I.; ODWYER, PETER J; SCHNALL, MITCHELL D. | ECOG-ACRIN MEDICAL RESEARCH FOUNDATION | NATIONAL CANCER INSTITUTE | 2014 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04438382
GET https://conductscience.org/api/trials/v1/NCT04438382/registered