Status:
TERMINATED
Siltuximab In Siltuximab-RElapsed/REfractory Multicentric CAstleman Disease
Lead Sponsor:
RECORDATI GROUP
Conditions:
Idiopathic Multicentric Castleman's Disease
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief Summary
Phase 2 study to investigate the safety, tolerability, and efficacy of administering increased siltuximab doses to patients with iMCD
Detailed Description
This is an open-label, two-stage, Phase 2 study to investigate the safety, tolerability, and efficacy of administering increased siltuximab doses to patients with iMCD who progressed with elevated and...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2021
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04838860
Start Date
March 31 2021
End Date
April 1 2021
Last Update
April 19 2021
Active Locations (1)
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1
Edward W. Sparrow Hospital
Lansing, Michigan, United States, 48912