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

NCT05899725 | Recruiting

• 1 other identifier: K22C2678
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Checkpoint Inhibitor Pneumonitis

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with dosage of corticosteroids no more than 10mg daily at improvement to CIP with CTCAE grade 1.

  Proportion of patients with dosage of corticosteroids no more than 10mg daily at improvement to CIP with CTCAE grade 1.

  8 weeks

Secondary Outcomes (5)

• Mortality

  8 weeks

• Proportion of invasive ventilator assisted respiration

  8 weeks

• Incidence of pulmonary infection

  8 weeks

• Total corticosteroids usage

  8 weeks.

• The incidence of treatment with immunosuppressants and the incidence of treatment with IVIG

  8 weeks.

Study Arms (2)

Cohort 1: severe CIP with the treatment of corticosteroids

ACTIVE COMPARATOR

severe CIP with the treatment of corticosteroids

Drug: Corticosteroids

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

EXPERIMENTAL

severe CIP with the treatment of corticosteroids and Ruxolitinib

Drug: Corticosteroids and Ruxolitinib

Interventions

Corticosteroids DRUG

Initial dosage of corticosteroids is no less than predinisone 1mg/kg/d or other corticosteroids with equal equivalence

Cohort 1: severe CIP with the treatment of corticosteroids

Corticosteroids and Ruxolitinib DRUG

Initial dosage of corticosteroids is no less 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

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

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years old≤ Aged ≤80 years old.
• Diagnosis of malignancy.
• Malignant tumors initially treated with immune checkpoint inhibitors (antibodies targeting PD-1, PD-L1, CTLA-4, or new immune checkpoint inhibitors) 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Department of Respiratory Medicine, Peking Union Medical College Hospita

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Interventions

Adrenal Cortex Hormones; ruxolitinib

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Yan Xu

CONTACT

+861069155154; maraxu@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Director of Department of Respiratory and Critical Care Medicine

Study Record Dates

• First Submitted: June 3, 2023
• First Posted: June 12, 2023
• Study Start: April 14, 2023
• Primary Completion: March 1, 2025
• Study Completion: June 30, 2025
• Last Updated: March 26, 2024

Record last verified: 2024-03

Locations

CN (1)