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The Efficacy and Safety of Corticosteroids in Combination With Ruxolitinib in the Management of Checkpoint Inhibitor Pneumonia

Primary Purpose

Severe Checkpoint Inhibitor Pneumonitis

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Corticosteroids
Corticosteroids and Ruxolitinib
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Checkpoint Inhibitor Pneumonitis

Eligibility Criteria

15 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 18 years old≤ Aged ≤75 years old. Diagnosis of malignancy. Malignant tumors initially treated with anti-PD-1 in combination with or without chemotherapy. Diagnosis of grade 3 or 4 CIP: CIP severity at CTCAE grade 3 or 4. Patients who and whose family members understand the study protocol, are willing to participate in the study and could provide written informed consent. Exclusion Criteria: Predicted life expectancy<12 weeks. Any evidence of active or uncontrolled viral infection, including hepatitis B, hepatitis C and human immunodeficiency virus (HIV), or any clinical signs of bacterial, other viral, parasitic or fungal infection requiring treatment. malignancy progression. Patients with other serious complications that may affect safety or adherence judged by the investigator. Any significant clinical and laboratory abnormalities judged by investigator that affect the safety evaluation. Patients can't fully understand the study protocol, arrangement and other study-related elements. Patients with evidence of severe liver or kidney dysfunction judged by investigator unsuitable for enrolment. Women who are pregnant, breast feeding or unable to use effective contraception during the study period and for 3 months after the completion. Patients who cannot comply with study treatment and follow-up according to the trial protocol.

Sites / Locations

  • Department of Respiratory Medicine, Peking Union Medical College HospitaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Cohort 1: severe CIP with the treatment of corticosteroids

Cohort 2: severe CIP with the treatment of corticosteroids and Ruxolitinib

Arm Description

severe CIP with the treatment of corticosteroids

severe CIP with the treatment of corticosteroids and Ruxolitinib

Outcomes

Primary Outcome Measures

Proportion of patients with dosage of corticosteroids less than 10mg daily at improvement to CIP with CTCAE grade 1.
Proportion of patients with dosage of corticosteroids less than 10mg daily at improvement to CIP with CTCAE grade 1.

Secondary Outcome Measures

Mortality
Mortality of severe CIP patients at 8 weeks.
Proportion of invasive ventilator assisted respiration
Proportion of invasive ventilator assisted respiration treatment for severe CIP patients at 8 weeks.
Incidence of pulmonary infection
Incidence of pulmonary infection in severe CIP patients in 8 weeks.
Total corticosteroids usage
Total corticosteroids usage for severe CIP patients in 8 weeks.
The incidence of treatment with immunosuppressants and the incidence of treatment with IVIG
The incidence of treatment with immunosuppressants and the incidence of treatment with IVIG for severe CIP patients in 8 weeks.

Full Information

First Posted
June 3, 2023
Last Updated
June 12, 2023
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05899725
Brief Title
The Efficacy and Safety of Corticosteroids in Combination With Ruxolitinib in the Management of Checkpoint Inhibitor Pneumonia
Official Title
The Efficacy and Safety of Corticosteroids in Combination With Biological Agents in the Management of Severe Immune Related Adverse Events Cohort A: The Efficacy and Safety of Corticosteroids or Corticosteroids Combination With Ruxolitinib in Patients With Severe Checkpoint Inhibitor Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 14, 2023 (Actual)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study is a prospective multicenter randomized controlled Interventional study, to assess the clinical efficacy and safety of corticosteroids compared to corticosteroids in combination with Ruxolitinib in the treatment of severe checkpoint inhibitor pneumonitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Checkpoint Inhibitor Pneumonitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1: severe CIP with the treatment of corticosteroids
Arm Type
Active Comparator
Arm Description
severe CIP with the treatment of corticosteroids
Arm Title
Cohort 2: severe CIP with the treatment of corticosteroids and Ruxolitinib
Arm Type
Experimental
Arm Description
severe CIP with the treatment of corticosteroids and Ruxolitinib
Intervention Type
Drug
Intervention Name(s)
Corticosteroids
Intervention Description
Initial dosage of corticosteroids is more than predinisone 1mg/kg/d or other corticosteroids with equal equivalence
Intervention Type
Drug
Intervention Name(s)
Corticosteroids and Ruxolitinib
Intervention Description
Initial dosage of corticosteroids is more than predinisone 1mg/kg/d or other corticosteroids with equal equivalence, add-on oral Ruxolitinib 5mg twice a day for 2 weeks, following with Ruxolitinib
Primary Outcome Measure Information:
Title
Proportion of patients with dosage of corticosteroids less than 10mg daily at improvement to CIP with CTCAE grade 1.
Description
Proportion of patients with dosage of corticosteroids less than 10mg daily at improvement to CIP with CTCAE grade 1.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Mortality
Description
Mortality of severe CIP patients at 8 weeks.
Time Frame
8 weeks
Title
Proportion of invasive ventilator assisted respiration
Description
Proportion of invasive ventilator assisted respiration treatment for severe CIP patients at 8 weeks.
Time Frame
8 weeks
Title
Incidence of pulmonary infection
Description
Incidence of pulmonary infection in severe CIP patients in 8 weeks.
Time Frame
8 weeks
Title
Total corticosteroids usage
Description
Total corticosteroids usage for severe CIP patients in 8 weeks.
Time Frame
8 weeks.
Title
The incidence of treatment with immunosuppressants and the incidence of treatment with IVIG
Description
The incidence of treatment with immunosuppressants and the incidence of treatment with IVIG for severe CIP patients in 8 weeks.
Time Frame
8 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years old≤ Aged ≤75 years old. Diagnosis of malignancy. Malignant tumors initially treated with anti-PD-1 in combination with or without chemotherapy. Diagnosis of grade 3 or 4 CIP: CIP severity at CTCAE grade 3 or 4. Patients who and whose family members understand the study protocol, are willing to participate in the study and could provide written informed consent. Exclusion Criteria: Predicted life expectancy<12 weeks. Any evidence of active or uncontrolled viral infection, including hepatitis B, hepatitis C and human immunodeficiency virus (HIV), or any clinical signs of bacterial, other viral, parasitic or fungal infection requiring treatment. malignancy progression. Patients with other serious complications that may affect safety or adherence judged by the investigator. Any significant clinical and laboratory abnormalities judged by investigator that affect the safety evaluation. Patients can't fully understand the study protocol, arrangement and other study-related elements. Patients with evidence of severe liver or kidney dysfunction judged by investigator unsuitable for enrolment. Women who are pregnant, breast feeding or unable to use effective contraception during the study period and for 3 months after the completion. Patients who cannot comply with study treatment and follow-up according to the trial protocol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Xu
Phone
+861069155154
Email
maraxu@163.com
Facility Information:
Facility Name
Department of Respiratory Medicine, Peking Union Medical College Hospita
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mengzhao Wang, MD
Phone
010-69155039
Ext
+86
Email
mengzhaowang@sina.com
First Name & Middle Initial & Last Name & Degree
Yan Xu, MD
Phone
18500296828
Ext
+86
Email
maraxu@163.com
First Name & Middle Initial & Last Name & Degree
Yan Xu, MD
First Name & Middle Initial & Last Name & Degree
Huang Hui, MD
First Name & Middle Initial & Last Name & Degree
Minjiang Chen, MD
First Name & Middle Initial & Last Name & Degree
Jing Zhao, MD
First Name & Middle Initial & Last Name & Degree
Wei Zhong, MD
First Name & Middle Initial & Last Name & Degree
Xiaoxing Gao, MD
First Name & Middle Initial & Last Name & Degree
Xiaoyan Liu, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

The Efficacy and Safety of Corticosteroids in Combination With Ruxolitinib in the Management of Checkpoint Inhibitor Pneumonia

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