Status:
ACTIVE_NOT_RECRUITING
AbataCept for the Treatment of Immune-cHeckpoint Inhibitors Induced mYocarditiS
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Myocarditis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Immune-checkpoint-inhibitors (ICI) have revolutionized treatment for about 20 cancer types. They unleash anti-tumor immune responses. Unfortunately, in 0.36-1.23% of patients, this activation can also...
Detailed Description
Immune-checkpoint-inhibitors (ICI) have revolutionized treatment for about 20 cancer types. They unleash anti-tumor immune responses. Unfortunately, in 0.36-1.23% of patients, this activation can also...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old
- Weight ≥ 40 kg and ≤ 125 kg
- Patients treated with ICI immunotherapy (monotherapy or combination), including anti-PD1, anti-PDL1, anti-CTLA4; and including any type of cancer (even those in which ICI is not currently approved by regulatory)
- Definite, probable or possible ICI-induced myocarditis according to the diagnostic criteria of the most recent expert consensus recommendations (e.g27, to be updated with any new recommendations to be published)
- Severe or corticosteroid-resistant ICI-myocarditis:
- Severe ICI-myocarditis is defined either 1/ by the appearance of an alteration of the LVEF\<50% or a wall motion kinetics abnormality, or 2/ by the appearance of ventricular tachycardias or high-grade conductive disorders (atrioventricular block grade 2 or 3) or 3/ by the association with myasthenia gravis-like-syndrome (diplopia, ptosis, diaphragmatic dysfunction, dysarthria, dysphonia, dysphagia) or 4/ by troponin-T levels above 32 times the upper limit of the normal (a population at very high-risk \~75% of major cardiomuscular events in the month following initial presentation, cf. Circulation. 2023 Aug 8;148(6):473-486).
- Corticosteroid-resistant ICI-myocarditis is defined by the absence of decrease in troponin levels or the appearance/persistence of severity criteria despite receiving prednisone dose ≥0.5 mg/kg/day for ≥2 days.
- Signature of informed consent before any trial procedure from the patient or legal representative or the close relative
- Patients covered by social security regimen (excepting AME)
- Withhold of ICI
Exclusion
- Untreated and/or uncontrolled bacterial, fungal, or viral infection
- Pregnancy, breast-feeding or planning to become pregnant during the study period
- For women of childbearing age, lack of effective contraception throughout the duration of participation in the study
- Being treated with abatacept or belatacept within 3 months prior to inclusion
- Known hypersensitivity to abatacept or belatacept
- Being treated with anti-thymoglobulin, or alemtuzumab within 6 weeks of the first scheduled dose of abatacept
- Patient participating to another interventional study (RIPH 1 only)
- People under legal protection measure (tutorship, curatorship or safeguard measures)
Key Trial Info
Start Date :
October 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2025
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT05195645
Start Date
October 4 2022
End Date
September 15 2025
Last Update
December 13 2024
Active Locations (1)
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1
Hôpital Pitié Salpêtrière
Paris, France, 75013