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Anti-TGF-beta Therapy in Patients With Myelofibrosis

NCT01291784 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2014-12-08

Study results available
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Summary

TGF-β is a cytokine that is found to be upregulated in the bone marrow of patients with myelofibrosis. This cytokine likely plays a dual role in promoting myelofibrosis and myeloproliferation, both of which are the bone marrow morphologic hallmark of MF. The investigators propose that inhibiting the TGF-β signaling pathway in MF will decrease the fibrogenic stimuli leading to myelofibrosis and concomitantly interrupt myeloproliferation. This is a novel approach to the treatment of patients with myelofibrosis.

Conditions

  • Myelofibrosis
  • Primary Myelofibrosis
  • Polycythemia Vera, Post-Polycythemic Myelofibrosis Phase
  • Post-essential Thrombocythemia Related Myelofibrosis

Interventions

BIOLOGICAL

monoclonal antibody to TGF-beta

starting dose of 1mg/kg intravenous over approximately 1 hour every 4 weeks for a total of 6 doses

Sponsors & Collaborators

  • John Mascarenhas

    lead OTHER

Principal Investigators

  • John Mascarenhas, MD · Icahn School of Medicine at Mount Sinai

  • Ronald Hoffman, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01291784 on ClinicalTrials.gov