Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2026-01-24 @ 4:14 AM
Study NCT ID:
NCT02805868
Status:
WITHDRAWN
Last Update Posted:
2016-10-24
First Post:
2016-06-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Siltuximab in Treating Patients With Primary, Post-Polycythemia Vera, or Post-Essential Thrombocythemia Myelofibrosis
Sponsor:
Northwestern University
Organization:
Study Overview
Official Title:
A Single-arm, Single Center, Pilot Study of Siltuximab, an Anti-IL6 Therapy, for Patients With Myelofibrosis
Status:
WITHDRAWN
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| STU00202680 | None | CTRP (Clinical Trial Reporting Program) | View | |
| NU 16H01 | OTHER | Northwestern University | View | |
| P30CA060553 | NIH | None | https://reporter.nih.gov/quic… | View |
| NCI-2016-00685 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |