Trial Outcomes & Findings for Infliximab and Intravenous Immunoglobulin Therapy in Treating Patients With Steroid-Refractory Pneumonitis (NCT NCT04438382)
NCT ID: NCT04438382
Last Updated: 2024-06-13
Results Overview
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.
TERMINATED
PHASE2
1 participants
At day 28
2024-06-13
Participant Flow
The study was activated on June 25, 2020 and one patient was enrolled on January 7, 2021. Due to slow accrual, the study was closed on December 14, 2023.
Participant milestones
| Measure |
Arm A (Infliximab)
Patients receive infliximab IV on day 1 followed by prednisone taper IV or PO for 4-6 weeks in the absence of disease progression or unacceptable toxicity. Patients may receive an additional dose of infliximab IV on day 14 at the discretion of the treating physician.
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Arm B (Intravenous Immunoglobulin Therapy)
Patients receive intravenous immunoglobulin therapy IV over 2-5 days per institutional guidelines followed by prednisone taper IV or PO for 4-6 weeks in the absence of disease progression or unacceptable toxicity.
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Overall Study
STARTED
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0
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1
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Overall Study
COMPLETED
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0
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1
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Infliximab and Intravenous Immunoglobulin Therapy in Treating Patients With Steroid-Refractory Pneumonitis
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: At day 28Population: Only one patient was enrolled on this study. Due to confidentiality reasons, individual data was not reported.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At days 1, 14, and 28Population: Only one patient was enrolled so individual data won't be reported due to confidentiality reasons.
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".
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At days 1, 14, and 28Population: Only one patient was enrolled, so individual data won't be reported due to confidentiality reasons.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At days 1, 14, and 28Population: Only one patient was enrolled so individual data won't be reported due to confidentiality reasons.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At days 1, 14, and 28Population: Only one patient was enrolled so individual data won't be reported due to confidentiality reasons.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: Only one patient was enrolled so individual data won't be reported due to confidentiality reasons.
Death reported in the 28-day period will be tabulated by treatment arm, and classified as pneumonitis-related, immunosuppression related, disease-related or other.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: Only one patient was enrolled so individual data won't be reported due to confidentiality reasons.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At days 1, 14, and 28Population: Only one patient was enrolled, so individual data won't be reported due to confidentiality reasons.
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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1, 14 and 28 after study treatmentPotential 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: On days 1, 14, and 28 post-treatmentTo evaluate associations between pneumonitis and autoantibodies, T cell expansion, and baseline cytokines in the blood.
Outcome measures
Outcome data not reported
Adverse Events
Arm A (Infliximab)
Arm B (Intravenous Immunoglobulin Therapy)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60