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

NCT02784496 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 2015-0872NCI-2016-01181
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myelofibrosis

Outcome Measures

Primary Outcomes (1)

• Most Common Treatment Related Adverse Events

  A review of the most common adverse events related to study medication will be performed. Will follow standard reporting guidelines for adverse events. Safety data will be summarized by the number of participants affected.

  to the date of failure or death from any cause, Up to 7 years, 3 months and 24 days

Study Arms (1)

Treatment (ruxolitinib, follow-up)

EXPERIMENTAL

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.

Other: Long-term Follow-up; Other: Quality-of-Life Assessment; Drug: Ruxolitinib

Interventions

Long-term Follow-up OTHER

Undergo follow-up assessment

Treatment (ruxolitinib, follow-up)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (ruxolitinib, follow-up)

Ruxolitinib DRUG

Given PO

Also known as: INCB-18424, INCB18424, Oral JAK Inhibitor INCB18424

Treatment (ruxolitinib, follow-up)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently enrolled in study 2007-0169 and benefiting from therapy as determined by treating physician
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at enrollment of this study
• Ability and agreement to attend protocol-specified visits at the study site
• Able to comprehend and willing to sign the informed consent form
• 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

You may not qualify if:

• \. none

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Primary Myelofibrosis

Interventions

ruxolitinib

Condition Hierarchy (Ancestors)

Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Prithviraj Bose, MD/Professor
• Organization: The University of MD Anderson Cancer Center

PBose@mdnaderson.org

713-792-7747

Study Officials

• Prithviraj Bose

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2016
• First Posted: May 27, 2016
• Study Start: September 29, 2016
• Primary Completion: January 23, 2024
• Study Completion: January 23, 2024
• Last Updated: August 29, 2025
• Results First Posted: August 29, 2025

Record last verified: 2025-08

Locations

US (1)