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:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07359859
Eligibility Criteria:
Inclusion Criteria:
* Patients ≥18- years-old at time of consent
* Diagnosis: hematologic malignancy in morphologic remission (blasts \<5%, no evidence of extramedullary disease in AML or MDS). Patients with CR with incomplete count recovery (CRp or CRi) or minimal residual disease are allowed. Patients with lymphoma must have a complete or partial response
* Donor: related or unrelated 7-8/8 HLA-matched or related haploidentical
* Karnofsky score ≥ 70%
* Female subjects of childbearing potential (\<50 years old) have a negative serum or urine pregnancy test. Females of childbearing potential are defined as females without prior hysterectomy or who have had any evidence of menses in the past 12 months.
°Sexually active females of childbearing potential enrolled in the study must agree to consistently use two forms of accepted methods of contraception during the course of the study and for 3 months after their last dose of the study drug. Effective birth control includes: \*Intrauterine device (IUD) plus one barrier method \*Stable doses of hormonal contraception for at least 3 months (e.g., oral, injectable, implant, transdermal) plus one barrier method \*2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gel that contain a chemical to kill sperm); or \* A vasectomized partner.
* For male subjects who are sexually active and who are partners of females of childbearing potential: Agreement to use two forms of contraception as per above and to not donate sperm during the treatment period and for at least 3 months after the last dose of study drug
Exclusion Criteria:
* Recipient of CD34+ selected or engineered stem cell graft
* Treatment with in vivo T cell depletion (e.g. anti-thymocyte globulin)
* Severely impaired renal function defined by serum creatinine \> 2mg/dL, renal dialysis requirement.
* Use of investigational agent within 14 days pre-HCT
* Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months
* Uncontrolled psychiatric illness
* Female patient who is pregnant or breastfeeding
* Known allergy or sensitivity to ruxolitinib
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07359859
Study Brief:
Protocol Section:
NCT07359859