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 @ 11:08 PM
Ignite Modification Date:
2025-12-24 @ 11:08 PM
NCT ID:
NCT03941769
Eligibility Criteria:
Inclusion Criteria:
* English and non-English speaking patients are eligible.
* Patient post a cord blood transplant (CBT) or haplo-SCT, with matched unrelated donors (MUDs), both peripheral blood (PB) and marrow sources with documented absolute neutrophil engraftment
* Patients with documented engraftment but require granulocyte-colony stimulating factor (G-CSF) to treat myelosuppression induced by drugs used to treat or prevent infection are eligible
* Karnofsky performance status (KPS) \> 60%
* Absence of dyspnea or hypoxia (\< 90% of saturation by pulse oximetry on room air)
* Bilirubin =\< 1.5 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and/or alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x ULN
* Prothrombin time (PT)/partial prothrombin time (PTT) \< 1.5 x ULN
* Calculated creatinine clearance \> 60 mL/min/1.73 m\^2
* Diagnosis of acute myeloid leukemia; myelodysplastic syndrome; chronic myeloid leukemia; myelofibrosis or myeloproliferative disease
Exclusion Criteria:
* Pregnant or nursing
* History of lymphoid malignancy (including Hodgkin disease, non-Hodgkin lymphoma, acute lymphoblastic leukemia and chronic lymphocytic leukemia) or acute biphenotypic leukemia
* Patients with acute GVHD \> grade 2 at any time during the post-transplant course
* Ongoing immunosuppressive therapy for the treatment of GVHD. Patients receiving GVHD prophylaxis will be allowed on this study
* History of Epstein-Barr virus (EBV) associated lymphoproliferation
* Active uncontrolled viral, bacterial or fungal infection
* History of autoimmune disease
* Receiving systemic corticosteroid therapy, budesonide is allowed
* Uncontrolled hypertension
* Corrected QT (QTc) prolongation (QTc \> 470 ms) or prior history of significant arrhythmia or electrocardiogram (ECG) abnormalities
* Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
* Patients with cognitive impairments and/or any past or current psychiatric illness that, in the opinion of the investigator, would interfere with adherence to study requirements or the ability and willingness to give written informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03941769
Study Brief:
Protocol Section:
NCT03941769