Long-Term Side Effects of Ruxolitinib in Treating Patients With Myelofibrosis

January 24, 2024 updated by: M.D. Anderson Cancer Center

Open-Label Roll-Over Study to Assess the Long-Term Safety and Efficacy of Ruxolitinib in Subjects With Myelofibrosis

This phase II trial studies the long-term side effects of ruxolitinib in treating patients with myelofibrosis. Collecting data about the long-term safety and tolerability of ruxolitinib may better help future patients with myelofibrosis.

Study Overview

Detailed Description

PRIMARY OBJECTIVES:

I. To collect long term safety and tolerability data in patients with myelofibrosis previously treated with ruxolitinib on protocol 2007-0169.

OUTLINE:

Patients continue to receive ruxolitinib orally (PO) once daily (QD) or twice daily (BID). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo follow-up assessment for safety over 10 minutes every 3 cycles.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Currently enrolled in study 2007-0169 and benefiting from therapy as determined by treating physician
  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at enrollment of this study
  3. Ability and agreement to attend protocol-specified visits at the study site
  4. Able to comprehend and willing to sign the informed consent form
  5. Negative pregnancy test in females of childbearing potential; male patients with female partners of child-bearing potential and female patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for 30 days following last dose; acceptable forms of contraception include 1 highly effective method such as an intrauterine device (IUD), hormonal (birth control pills, injections, or implants), tubal ligation, or partner's vasectomy and at least 1 additional approved barrier method such as a latex condom, diaphragm, or cervical cap; female patients of childbearing potential must not be breast-feeding or planning to breast feed and must have a negative pregnancy test 7 days before first study treatment

Exclusion Criteria:

1. none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (ruxolitinib, follow-up)
Patients continue to receive ruxolitinib PO QD or BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo follow-up assessment for safety over 10 minutes every 3 cycles.
Ancillary studies
Other Names:
  • Quality of Life Assessment
Given PO
Other Names:
  • INCB-18424
  • INCB18424
  • Oral JAK Inhibitor INCB18424
Undergo follow-up assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: Up to 3 years
Safety data of the patients will be summarized using descriptive statistics such as mean, standard deviation, median and range. Will follow standard reporting guidelines for adverse events. Safety data will be summarized by category, severity and frequency.
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Prithviraj Bose, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2016

Primary Completion (Actual)

January 23, 2024

Study Completion (Actual)

January 23, 2024

Study Registration Dates

First Submitted

May 20, 2016

First Submitted That Met QC Criteria

May 26, 2016

First Posted (Estimated)

May 27, 2016

Study Record Updates

Last Update Posted (Estimated)

January 25, 2024

Last Update Submitted That Met QC Criteria

January 24, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2015-0872 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2016-01181 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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