Phase 3 Heart Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with a long-term low white blood cell condition (called chronic neutropenia) that is congenital (present from birth) or has developed over time due to an autoimmune or unknown cause, and where the condition has been present for at least 6 months before the screening visit — and is not caused by medications, infections, or cancer.
• People whose neutropenia falls into one of these categories: a congenital (inherited) type, such as those linked to specific gene changes (e.g., ELANE, CSF3R, WAS) or syndromes (e.g., Barth syndrome, Cohen syndrome, Shwachman-Diamond syndrome, GSD1b); or an acquired type, such as chronic idiopathic neutropenia or primary autoimmune neutropenia (other types may also be considered after discussion with the study's medical team).
• People whose blood test during screening shows a low neutrophil count (below 1,000 cells per microlitre), with this confirmed again at the baseline visit, and with no current signs of a body-wide infection.
• People who have had a history of repeated or serious infections in the 12 months before screening — meaning at least 2 infections during that time that either required antibiotic treatment (by mouth or through a drip) or required a visit to a healthcare facility (such as a hospital, emergency room, or doctor's office), and where the treating doctor considers those infections likely related to the neutropenia condition.
• People who are already taking a treatment called G-CSF (or another background therapy) must have been on it for the previous 12 months, still been getting infections during that time, been on a stable dose for at least 4 weeks before screening, and be willing to keep that dose stable throughout the study (unless the neutrophil count rises significantly).
• People who are willing to keep their G-CSF or other background therapy doses and schedules unchanged for the full duration of the study, unless there is a safety reason to change.

Who may not be able to join:

• People whose low neutrophil count is caused by a secondary (not primary) condition, such as an enlarged spleen, an active infection, cancer, autoimmune diseases (e.g., lupus, rheumatoid arthritis, inflammatory bowel disease, thyroid disease, graft-versus-host disease), nutritional deficiencies (e.g., low vitamin B12, folate, or copper), or medications (e.g., chemotherapy, clozapine, antibiotics, or certain other drugs).
• People diagnosed with aplastic anemia, WHIM syndrome, or certain specific types of chronic neutropenia — including cyclic neutropenia (where the neutrophil count goes up and down in a cycle), neutropenia linked to immune system problems (e.g., CVID, Chédiak-Higashi syndrome, GATA2 deficiency, familial hemophagocytic lymphohistiocytosis, ALPS), or neutropenia associated with bone marrow failure conditions (e.g., Fanconi anemia or Diamond-Blackfan anemia).
• People whose low neutrophil count is linked to a genetic trait called Duffy-null phenotype (previously known as benign ethnic neutropenia) — although people with this background who also have a confirmed gene change associated with chronic neutropenia may still be considered (confirm with trial site).
• People with a medical or personal situation that the investigator or medical monitor believes could put them at risk, prevent them from completing the study, or interfere with the study's goals.
• People who have previously received more than one dose of the study drug, mavorixafor.
• People who have taken a different drug in the same class as mavorixafor (called a CXCR4 antagonist) within the past 6 months.
• People currently taking a long-acting form of G-CSF called pegylated-G-CSF, unless they have a confirmed diagnosis of congenital neutropenia.
• People who have taken another experimental (investigational) drug within 30 days before the screening visit, or within 5 half-lives of that drug — whichever period is longer.

Important: Always verify eligibility with the trial site directly before applying.