Blood and Lymph Conditions

All Conditions

Neoplasms

Rare Diseases

Anemia

Thrombocytopenia

Polycythemia Vera

Polycythemia

Primary Myelofibrosis

Thrombocytosis

Thrombocythemia, Essential

Blood Platelet Disorders

Hematologic Diseases

Cytopenia

Myeloproliferative Disorders

Bone Marrow Diseases

Bone Marrow Neoplasms

Hematologic Neoplasms

Essential Thrombocythemia

Chronic Myeloproliferative Disorders

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Siltuximab

Immunologic Factors

Patients receive siltuximab IV over 60 minutes on day 1. Patients also undergo bone marrow biopsy and aspiration at baseline and at the end of treatment (within 30 days of last siltuximab dose) or as clinically indicated. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who are responding after 6 courses may receive additional siltuximab treatment for up to 1 year at the discretion of the study doctor.

Undergo bone marrow aspiration and biopsy

Bone Marrow Aspiration and Biopsy

Laboratory Biomarker Analysis

Brady Stein, MD

The main purpose of this investigational research study is to determine how safe and tolerable the study drug siltuximab is in patients with myelofibrosis (MF). This medication has been approved by the FDA for another condition (multicentric castleman's disease (MCD), but not for myelofibrosis (MF). In MCD, siltuximab resulted in improvement in symptoms and anemia. While MCD and MF are different diseases, they share some common features including a protein call interleukin-6 (IL-6) that may be important in causing symptoms of MCD and MF.

PRIMARY OBJECTIVES:

I. To evaluate safety and tolerability of the drug siltuximab in the myelofibrosis patient population.

SECONDARY OBJECTIVES:

I. To determine clinical improvement (CI). II. To determine the overall response rate (ORR).

TERTIARY OBJECTIVES:

I. To determine if siltuximab results in improvement in iron dysregulation. II. To determine changes in inflammatory stress that may correlate with clinical response.

OUTLINE:

Patients receive siltuximab intravenously (IV) over 60 minutes on day 1. Patients also undergo bone marrow biopsy and aspiration at baseline and at the end of treatment (within 30 days of last siltuximab dose) or as clinically indicated. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression, unacceptable toxicity, or patient decision to withdraw. Patients who are responding after 6 courses may receive additional siltuximab treatment for up to 1 year at the discretion of the study doctor.

After completion of study treatment, patients are followed up at 30 days.

Siltuximab in Treating Patients With Primary, Post-Polycythemia Vera, or Post-Essential Thrombocythemia Myelofibrosis

A Single-arm, Single Center, Pilot Study of Siltuximab, an Anti-IL6 Therapy, for Patients With Myelofibrosis

Peripheral blood will be taken to determine if siltuximab results in improvement in iron dysregulation.

To determine changes in inflammatory stress that may correlate with clinical response. To assess this, CRP will be measured.

To determine changes in inflammatory stress that may correlate with clinical response. To assess this, hepcidin will be measured.

To evaluate safety and tolerability of the drug siltuximab in the myelofibrosis patient population. Adverse events will be assessed by type, timing, frequency, and attribution and will be graded according to the NCI's common terminology criteria, version 4.03.

Changes in the baseline symptom burden using Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) questionnaire.

To determine spleen response, palpation will be used, using centimeters below the left costal margin, and if body habitus is prohibitive, by ultrasonography.

Baseline hemoglobin level and/or transfusion-dependence will be recorded at baseline and compared to results after cycle 3

The ORR will be assessed after 6 cycles of therapy using standard criteria published by the International Working Group for Myelofibrosis Research and Treatment which will evaluate for complete response, partial response, clinical improvement, or stable disease.

National Cancer Institute (NCI)

Northwestern University

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Bevacizumab

Chlorotrianisene

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

TACE treatment once; Adebrelimab: 20mg/kg, every 3 weeks (21 days); Bevacizumab; 15mg/kg, every 3 weeks (21 days);

TACE with adebrelimab and bevacizumab

Jianbo Chen

Feng Ye

congren Wang

Qinghe Cai

Jiafei Chen

Yongzhong Wang

Feng Lin

To evaluate the efficacy and safety of TACE combined with adebrelimab and bevacizumab transformation in unresectable hepatocellular carcinoma

Single Arm, Prospective, Multicenter Clinical Study of TACE With Adebrelimab and Bevacizumab for Unresectable Hepatocellular Carcinoma

Refers to the proportion of all subjects with the best overall response (BOR) as complete remission (CR) or partial remission (PR) according to mRECIST 1.1 criteria.

Occurence of Adverse Event (AE) and Serious Adverse Event (SAE) （NCI CTCAE 5.0）

The cut margin had no residual cancer cells

The ates of conversion to operable patients in inoperable patients

The rate of no remaining tumor cells in the excised tissue samples

The ratio of the tumor cells active in the removed tissue samples is less than 10%.

PFS was defined as the subject's date from the date of the first dose to the date of the first documented tumor progression (as assessed by mRECIST criteria, with or without continuation of treatment) or the date of death from any cause, whichever occurred first.

Refers to the proportion of all subjects with the best overall response (BOR) according to mRECIST criteria as complete remission (CR), partial remission (PR) and stable disease (SD).

Time from date of cure surgery to time of recurrence or death

Defined as the time from the date of the first dose to the death of the subject from any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Siltuximab in Treating Patients With Primary, Post-Polycythemia Vera, or Post-Essential Thrombocythemia Myelofibrosis	NCT02805868	Myelofibrosis Polycythemia Ve... Primary Myelofi... Thrombocytopeni...	Bone Marrow Asp... Laboratory Biom... Siltuximab	18 Years -	Northwestern University
Single Arm, Prospective, Multicenter Clinical Study of TACE With Adebrelimab and Bevacizumab for Unresectable Hepatocellular Carcinoma	NCT05970666	Adebrelimab Hepatocellular ... Transformation Bevacizumab TACE	TACE with adebr...	18 Years - 75 Years	The First Affiliated Hospital of Xiamen University

Spots Global Cancer Trial Database for transformation