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:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT01058993
Eligibility Criteria:
Inclusion Criteria:
* age over 18 years, WBC (white blood count) less than 3.0 x 10\^9 per Liter,
* Absolute neutrophil count less than 2.0 x 10\^9 per Liter,
* platelets greater than 100 x 10\^6 per Liter, creatinine less than 2.0/milligrams per/deciliter,
* Creatinine clearance \> 60 ml/min calculated,
* Aspartate Aminotransferase-GOT (SGOT), Alanin Aminotransferase-GPT (SGPT), bilirubin \< 2.5 upper limit of normal,
* Eastern Cooperative Oncology Group (ECOG) status 0 or 1,
* mutation identified and confirmed in CXCR4,
* on no granulocyte-colony stimulating factor (G-CSF), granulocyte-macrophage-colony stimulating factor (GM-CSF) within 3 weeks of the study drug
* patient signs consent, accepts contraception
Exclusion Criteria:
* greater than 18 years of age,
* sensitivity to plerixafor,
* pregnant,
* prisoner,
* decisionally impaired,
* judged unlikely to comply,
* illness that may interfere with interpretation of results,
* leukemia,
* malignancy,
* active infection requiring antibiotics within one week of study drug administration,
* history of cardiac conduction or electrocardiogram (EKG) abnormality,
* previous experimental therapy within one week.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01058993
Study Brief:
Protocol Section:
NCT01058993