Search / Trial NCT06221501

Perioperative Efgartigimod for Thymoma and Myasthenia Gravis

Launched by SHANGHAI ZHONGSHAN HOSPITAL · Jan 13, 2024

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Trial Information

Current as of October 04, 2024

Not yet recruiting

Keywords

Description

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Adult patients aged ≥ 18 years and ≤ 75 years with expected survival time \> 12 months;
  • 2. Patients with systemic Myasthenia gravis;
  • 3. AChR Antibody positive;
  • 4. MGFA Type II- IV;
  • 5. Clinical diagnosis of Neoplasm of thymus by enhanced chest CT (clinical stage: Masaoka-Koga Stage I-IVa);
  • 6. Patients with American Society of Anesthesiologists (ASA) classification of 1-2;
  • 7. Subjects have no dysfunction of major organs; blood routine, lung, liver, kidney function and cardiac function are basically normal; laboratory test indicators must meet the following requirements: Blood: White cells \> 4.0 x 109/L, absolute count of neutrophils (ANC) ≥ 2.0 x 109/L, Thrombocyte count \> 100 x 109/L, Hemoglobin \> 90 g/L; Lung function: FEV1 ≥ 1.2 L, FEV1% ≥ 50% and DLCO ≥ 50%. Note: FEV1: Forced vital capacity measured value (liter). FEV1%:% of Forced vital capacity observed/predicted. DLCO%: measured/predicted value% of diffusion capacity of the CO in one breath; Liver function: Serum bilirubin less than 1.5 times the maximum normal value; ALT and AST less than 1.5 times the maximum normal value; Renal function: blood creatinine (SCr) ≤ 120 µmol/L, creatinine clearance (CCr) ≥ 60 ml/min;
  • 8. Understand the study and sign the informed consent form.
  • Exclusion Criteria:
  • 1. Patients whose imaging investigation suggests that the tumor has already had hematogenous metastasis (clinical stage: Masaoka-Koga IVb);
  • 2. Patients with ocular muscular myasthenia gravis (OMG);
  • 3. Patients who have received median sternotomy ;
  • 4. Documented history of congestive cardiac failure; poorly controlled drug therapy on Anginal pain; electrocardiogram (ECG) documented transmural myocardial infarction; poorly controlled hypertensive; clinically significant heart valve disorders; or high-risk uncontrolled arrhythmia;
  • 5. Patients with a loss of more than 5 Kg within the past month; severe uncontrolled systemic intercurrent illness such as active Infection or poorly controlled Diabetes mellitus; patients with combined Hemorrhagic disorder and Haemorrhagic diathesis; patients with abnormal coagulation function, having haemorrhagic diathesis or receiving thrombolysis or anticoagulant therapy; and patients with grade II-IV myelosuppression.
  • 6. Serum pregnancy test positive or lactating females, as well as males and females of childbearing potential who are unwilling to take adequate contraception measures during treatment;
  • 7. History of organ transplant (including autologous bone marrow Transplant and peripheral Stem cell transplant);
  • 8. Patients with peripheral nervous system disorders or significant history of Mental disorder and central nervous system disorders;
  • 9. Concurrent participation in other clinical investigators.
  • 10. Patients who cannot tolerate one-lung ventilation in the Surgery; patients with severe cardiac complications, cardiovascular compensatory dysfunction, cardiac pacemaker implantation;
  • 11. Patients with acute Inflammation due to bacterial, viral or other pathogenic microorganism Infection; known Immunodeficiency virus (HIV), Hepatitis B virus (HBV) or Hepatitis C virus (HCV) active Infection or known HIV seropositivity;
  • 12. Patients who previously underwent Thoracic operation for Tuberculous pleurisy, Mesothelioma, Pulmonary disorder, diaphragmatic disease, ipsilateral Atelectasis involving one lobe or more than one lobe;
  • 13. Serum IgG level \< 6 g/L;
  • 14. Received biologic agents such as rituximab or eculizumab within 6 months; IV Immunoglobulins or Plasma exchange within 1 month;

About Sponsor

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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