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

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02784496
Collaborator
National Cancer Institute (NCI) (NIH)
8
Enrollment
1
Location
1
Arm
96
Anticipated Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

PRIMARY OBJECTIVES:
  1. 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 Design

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Open-Label Roll-Over Study to Assess the Long-Term Safety and Efficacy of Ruxolitinib in Subjects With Myelofibrosis
Actual Study Start Date :
Sep 29, 2016
Anticipated Primary Completion Date :
Sep 30, 2024
Anticipated Study Completion Date :
Sep 30, 2024

Arms and Interventions

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.

Other: Long-term Follow-up
Undergo follow-up assessment

Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment

    • Drug: Ruxolitinib
    Given PO
    Other Names:
  • INCB-18424
  • INCB18424
  • Oral JAK Inhibitor INCB18424

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of adverse events [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 M D Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

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

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT02784496
    Other Study ID Numbers:
    • 2015-0872
    • NCI-2016-01181
    • 2015-0872
    First Posted:
    May 27, 2016
    Last Update Posted:
    Jul 12, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Primary Myelofibrosis
    Janus Kinase Inhibitors

    Study Results

    No Results Posted as of Jul 12, 2022