Rituximab and Abatacept Effectiveness in Differential Treatment of Interstitial Lymphocytic Lung Disease in Children With Primary Immunodeficiencies.

Sponsor
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Study ID
NCT04572620
Status
Unknown

Conditions

  • Interstitial Lymphocytic Lung Disease

Eligibility Criteria

Sex
ALL
Age
N/A - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    375 mg/m2 as 4 weekly consecutive i.v. infusions with subsequent infusions of 375 mg/m2 performed every 3 months for 12 months.
  • Abatacept — DRUG
    10 mg/kg i.v. every 2 weeks twice, then every 4 weeks for 12 months.

Study Details

The rationale for this retrospective study is to evaluate the efficacy and safety of abatacept and rituximab treatment of ILLD in a cohort of pediatric patients with different forms of PID, who received one of the two therapy regimens predominantly based on the lesions histopathology.

Key Dates

Start date
Sep 7, 2020
Status verified
Sep 2020
Primary completion
Sep 30, 2021
Completion
Sep 30, 2021

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: group 1(rituximab)
  • Arm: group 2 (abatacept)

Primary Outcome Measure

Dynamics of severity clinical and radiological symptoms [ Time Frame: before the time the first dose of study treatment was administered ]

Central Contacts