Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2025-12-24 @ 1:36 PM
NCT ID:
NCT01790295
Eligibility Criteria:
Inclusion Criteria:
* Documented diagnosis of primary myelofibrosis according to WHO criteria or post PV myelofibrosis or post ET myelofibrosis as per IWG-MRT criteria
* Age 18-70 years
* Intermediate-2/ high-risk disease as per Dynamic IPSS (DIPSS) criteria OR Intermediate-1 risk disease with one of the following additional unfavorable features known to impact the survival adversely
1. Red cell transfusion dependency
2. Unfavorable Karyotype
3. Platelet count \<100 x 109/l
* Blasts in the PB and BM ≤10% prior to study enrollment
* Availability of a suitable matched related (6/6 or 5/6) or unrelated donor (10/10 or 9/10 antigen or allele matched).
* Able to give informed written consent
* ECOG Performance status of 0-2.
* Life expectancy \>3 months
* Off all MF-directed therapy including investigational agents for at least 2 weeks prior to study enrollment and recovered from all toxicities\*
* Adequate organ function
* Adequate renal function - creatinine \<1.5 x IULN
* Adequate hepatic function - AST/ALT \<2.5 x IULN, Total Bilirubin \<1.5 x IULN
* Adequate hematopoietic function - Platelet ≥50 x 109/l and ANC ≥1.0 x 109/l
* LVEF \>40% (MUGA or echocardiogram) Normal per Institutional standard
* Adequate pulmonary function with DLCO \>50%
* A patient who has been on stable dose of Ruxolitinib and has received ruxolitinib ≤6 months prior to the study entry will be considered potentially eligible for the study with the caveat that there is no evidence of loss of response (\>5cm increase in spleen size from the nadir).
Exclusion Criteria:
* Any previous JAK2 inhibitor treatment prior to study enrollment, with the exception of Ruxolitinib
* Hypersensitivity to JAK inhibitor
* Clinical or laboratory evidence of cirrhosis
* Prior allogeneic transplant for any hematopoietic disorder
* \>20% blast in the PB or BM prior to HCT or had leukemic transformation (\>20% blasts in PB or BM any time prior to HCT)
* Syngeneic donor
* Cord Blood transplant
* Active uncontrolled infection
* H/o another malignancy within 5-years of date of HCT except h/o basal cell or squamous cell carcinoma of skin or PV or ET
* Known HIV positive
* Pregnancy at the time of BMT
* Any other concurrent illness which in investigator's opinion puts the patient at excessive risk of treatment related toxicities
* Unable to give informed consent
* Active infection with hepatitis A,B or C virus
* Subjects who require therapy with a strong CYP3A4 inhibitor prior to enrollment to this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01790295
Study Brief:
Protocol Section:
NCT01790295