Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT04838860
Eligibility Criteria:
Inclusion Criteria:
* Documented history of consensus histologic, laboratory, and clinical diagnostic criteria of iMCD.
* Archival and/or baseline incisional/excisional biopsy for retrospective central histologic confirmation of iMCD.
* CDCNRC-defined disease progression on or after prior treatment with siltuximab at 11 mg/kg q3w without unacceptable toxicity within 12 weeks between the last dose of siltuximab and the date of signed patient informed consent form (ICF).
* At least 1 measurable abnormal lymph node mass that is ≥1 cm in its longest transverse diameter as assessed by computerized tomography (CT) scan that has not been previously irradiated.
* Elevated (\>10 mg/L) and rising serum CRP in the absence of additional iMCD treatment.
* Evidence of at least an additional one of the following laboratory or clinical signs of iMCD per international, evidence-based consensus diagnostic criteria for HIV or HHV 8-negative iMCD:
* Anemia, thrombocytopenia, hypoalbuminemia, renal dysfunction, or polyclonal hypergammaglobulinemia.
* Constitutional symptoms (night sweats, fever (\>38°C), weight loss, or fatigue (CTCAE lymphoma B-symptoms score ≥2), large spleen and/or liver, fluid accumulation, eruptive cherry hemangiomatosis/violaceous papules, or lymphocytic interstitial pneumonitis.
* Adequate clinical laboratory measurements within 3 weeks prior to study entry in all parameters below:
* Absolute neutrophil count ≥1.0 × 109/L, hemoglobin \<17 g/dL, and platelets ≥50 × 109/L without transfusion, hematopoietic growth factors, or both for \>7 days prior to measurement.
* AST, ALT, total bilirubin, and alkaline phosphatase ≤5 × ULN.
* Fasting cholesterol \<300 mg/dL and fasting triglyceride \<400 mg/dL.
* Age ≥12 years.
Exclusion Criteria:
* Documentation of HIV or HHV-8 infection or presence of other infection-related disorders that resemble clinical or histological features of iMCD
* Diagnosis of any malignant/benign lymphoproliferative disorders
* Diagnosis of autoimmune/autoinflammatory disease
* Treatment with corticosteroids (prednisone dose-equivalent \>1 mg/kg/day) within 7 days prior to study entry.
* History of solid organ transplant, allogeneic bone marrow transplant, or allogeneic peripheral blood stem cell transplant.
* Previous malignancy with the following exceptions:
* Past malignancy with treatment that was completed at least 2 years before signing informed consent and the patient has no evidence of disease, or
* Concurrent malignancy that is clinically stable and does not require tumor-directed treatment (eg, nonmelanoma skin cancer and carcinoma in situ)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT04838860
Study Brief:
Protocol Section:
NCT04838860