Clinical Trials Logo
  1. Home
  2. Myelofibrosis
  3. NCT05665192
  4. Details
NCT05665192 Clinical Trial

A Study to Assess Real-World Patient-Reported Outcomes With Fedratinib for Myelofibrosis Post-Ruxolitinib

Myelofibrosis Clinical Trial

Official title:
Real-World Clinical and Patient Reported Outcomes With Fedratinib for Myelofibrosis Post-Ruxolitinib

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05665192
Other study ID # NDS-MF-001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 2, 2021
Est. completion date December 31, 2025

Study information
Verified date December 2022
Source Bristol-Myers Squibb
Contact BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone 855-907-3286
Email Clinical.Trials@bms.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to determine real-world patient-reported outcomes with fedratinib (FEDR) therapy for myelofibrosis (MF) in the real-world (RW) setting.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date December 31, 2025
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosed with Primary myelofibrosis (PMF), post- Essential thrombocythemia (ET) Myelofibrosis (MF), or post- Polycythemia vera (PV) MF - Treated with FEDR and initiated treatment after 16 August 2019. - Received prior treatment with RUX. - Had spleen assessed at time of initiation of FEDR by palpation. - Able to read and speak English - Willing to provide informed consent - Willing to provide permission to the site to release her/his medical information to the study investigators according to the study-specific eCRF - Willing to complete the baseline survey prior to first FEDR Exclusion Criteria: - Past or current participant in any FEDR-related clinical trial

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Austria Local Institution City State

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage change in Total Symptom Score (TSS) assessed by Myelofibrosis Symptom Assessment Form (MFSAF) At Baseline, 3 and 6 months post-FEDR initiation
Primary Absolute change in TSS assessed by MFSAF At Baseline, 3 and 6 months post-FEDR initiation
Primary Proportion of participants reporting individual symptoms in TSS assessed by MFSAF At Baseline, 3 and 6 months post-FEDR initiation
Primary Severity of each reported symptom in TSS assessed by MFSAF At Baseline, 3 and 6 months post-FEDR initiation
Primary Frequency of report of domain assessed by Patients' Global Impression of Change (PGIC) At Baseline, 3 and 6 months post-FEDR initiation
Primary Absolute reduction assessed by Patient-Reported Outcomes Measurement Information System Global-10 (PROMIS-10) At Baseline, 3 and 6 months post-FEDR initiation
See also
  Status Clinical Trial Phase
Completed NCT02916979 - Myeloid-Derived Suppressor Cells and Checkpoint Immune Regulators' Expression in Allogeneic SCT Using FluBuATG Phase 1
Not yet recruiting NCT06345495 - High Dose Ruxolitinib and Allogeneic Stem Cell Transplantation in Myelofibrosis Patients With Splenomegaly Phase 2
Terminated NCT04866056 - Jaktinib and Azacitidine In Treating Patients With MDS With MF or MDS/MPN With MF. Phase 1/Phase 2
Completed NCT02784496 - Long-Term Side Effects of Ruxolitinib in Treating Patients With Myelofibrosis Phase 2
Completed NCT00069680 - Genetic Analysis of Gray Platelet Syndrome
Active, not recruiting NCT04097821 - Platform Study of Novel Ruxolitinib Combinations in Myelofibrosis Patients Phase 1/Phase 2
Active, not recruiting NCT03289910 - Topotecan Hydrochloride and Carboplatin With or Without Veliparib in Treating Advanced Myeloproliferative Disorders and Acute Myeloid Leukemia or Chronic Myelomonocytic Leukemia Phase 2
Completed NCT04666025 - SARS-CoV-2 Donor-Recipient Immunity Transfer
Not yet recruiting NCT06397313 - RVU120 in Patients With Intermediate or High-risk, Primary or Secondary Myelofibrosis Phase 2
Not yet recruiting NCT06024915 - A Study to Evaluate Drug-Drug Interaction of TQ05105 Tablets Phase 1
Terminated NCT02877082 - Tacrolimus, Bortezomib, & Thymoglobulin in Preventing Low Toxicity GVHD in Donor Blood Stem Cell Transplant Patients Phase 2
Completed NCT02910258 - Interferon-pegyle α2a Efficiency and Tolerance in Myelofibrosis
Completed NCT00975975 - Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent Graft-Versus_Host Disease (GVHD) After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer Phase 2
Completed NCT00997386 - Reduced Intensity Allogeneic PBSCT to Treat Hematologic Malignancies and Hematopoietic Failure States Phase 2
Completed NCT00666549 - Research Tissue Bank
Terminated NCT00522990 - Study to Assess the Safety of Escalating Doses of AT9283, in Patients With Leukemias Phase 1/Phase 2
Terminated NCT00393380 - Study of Parathyroid Hormone Following Sequential Cord Blood Transplantation From an Unrelated Donor Phase 2
Completed NCT00606437 - Total Body Irradiation With Fludarabine Followed by Combined Umbilical Cord Blood (UCB) Transplants Phase 1
Active, not recruiting NCT03952039 - An Efficacy and Safety Study of Fedratinib Compared to Best Available Therapy in Subjects With DIPSS-intermediate or High-risk Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis and Previously Treated With Ruxolitinib Phase 3
Not yet recruiting NCT04709458 - Safety and Early Efficacy Study of TBX-2400 in Patients With AML or Myelofibrosis Phase 1

External Links