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 @ 10:47 PM
Ignite Modification Date:
2025-12-24 @ 10:47 PM
NCT ID:
NCT03426969
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of primary or secondary Myelofibrosis with transplant indication by DIPSS-plus (\> intermediate -1);
* Age 18-70; patients \>/= age 50 must have an comorbidity score (HCT-CI) \</= 4 (Sorror). The Principal Investigator is the final arbiter for comorbidity;
* Patients can be in chronic phase (CP) with BM blast count \</= 10% or after progression to AML and achieved \</= 5% BM blasts (morphologic CR prior to transplant);
* Lack of an HLA matched donor or need to proceed fast to transplantation when a patient does not have an immediately available matched unrelated donor (typed by high-resolution in the registry);
* Performance status \>/=70% (Karnofsky); patients \> 50 years should have adequate cognitive function; any concerns regarding cognitive function should be addressed by a Geriatrician/Neurologist;
* Adequate organ function: ALT/AST/billirubin \</= 5X UNL, creatinine clearance \> 50mls/min (calculated with Cockroft-Gault formula); LVEF \>/= 50%, DLCOc \>/= 50%;
* Prior treatment with JAK2 inhibitor therapy is not excluded. Patients on a JAK2 inhibitor may continue through conditioning until Day -3 then tapered at the discretion of the investigator.
Exclusion:
* Evidence of portal hypertension with varices, ascites, or hepatic encephalopathy;
-\>10% bone marrow blasts at transplant if no history of AML and \>5% if had previous progression to AML;
* HIV positive; active hepatitis B or C;
* Patients with active infections. The PI is the final arbiter of the eligibility;
* Liver cirrhosis;
* Prior CNS involvement by tumor cells;
* Severe pulmonary hypertension (PHT) (On echo or right side cardiac catheterization);
* History of another primary malignancy that has not been in remission for at least 3 years (the following are exempt from the 3-year limit: non-melanoma skin cancer, fully excised melanoma in situ \[Stage 0\], curatively treated localized prostate cancer, and cervical or breast carcinoma in situ on biopsy or a squamous intraepithelial lesion on PAP smear);
* Positive Beta HCG test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization;
* Noncompliance - Inability or unwillingness to comply with medical recommendations regarding therapy or follow-up, including smoking tobacco. Smoking cessation is a standard teaching practice prior to admission for all patients undergoing stem cell transplant. Any patient who refuses to stop smoking prior to transplant will not be eligible for this study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03426969
Study Brief:
Protocol Section:
NCT03426969