Ruxolitinib versus allogeneic stem cell transplantation for patients with myelofibrosis according to donor availability: A prospective phase II trial

Phase 1

• Conditions: primary myelofibrosis; MedDRA version: 20.0Level: PTClassification code 10028537Term: MyelofibrosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-005210-28-DE
• Lead Sponsor: niversity Medical Center Hamburg-Eppendorf

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-23
• Last Update Posted: 14 June 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 155

Inclusion Criteria

1.Symptomatic primary myelofibrosis or myelofibrosis post polycythaemia vera or essential thrombocythemia stage intermediate 2- or high-risk according to IPSS or DIPSS [46] or inter-mediate 1-risk with high risk cytogenetics, other than normal karyotype, sole del 20q, del 13q, or sole +9, or transfusion-dependency
2.Patients age: 18 - 70 years at time of inclusion (female and male)
3.Patients understand and voluntarily sign an informed consent form
4.Platelet count = 50 x 109/L
5.No prior Ruxolitinib treatment
6.ECOG = 2

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55

Exclusion Criteria

1.Severe renal, hepatic, pulmonary or cardiac disease, such as:
•Total bilirubin, SGPT or SGOT > 3 times upper the normal level
•Left ventricular ejection fraction < 30 %
•Creatinine clearance < 30 ml/min
•DLCO < 35 % and/or receiving supplementary continuous oxygen
2.Positive serology for HIV
3.Pregnant or lactating women (positive serum pregnancy test)
4.Age < 18 and = 71 years.
5.Uncontrolled invasive fungal infection at time of screening (baseline)
6.Serious psychiatric or psychological disorders
7.Participation in another study with ongoing use of unlicensed investigational product from 28 days before study enrollment
8.Transformation to AML

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified