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 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT01120457
Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
A. Common to All Indications:
* Life expectancy at least 12 weeks
* ECOG Performance Status of 0-2
B. For Acute myelogenous leukemia (AML) Subjects:
* First Relapse and primary induction failure in AML (M3 excluded)
* Secondary AML subjects from myelodysplastic syndrome (MDS) or prior chemotherapy are eligible. MDS-only subjects are not eligible
C. For Follicular Lymphoma (FL), Diffuse Large B-Cell Lymphoma (DLBCL) Subjects:
* Must be at least 4 weeks (for FL) or 2 weeks (for DLBCL) since prior cytotoxic, biologic, monoclonal antibody, or investigational therapy
* Ability to undergo tumor biopsy pre-treatment and at end of monotherapy period (though not mandatory for all subjects)
* Subjects must have a histologically confirmed diagnosis of relapsed or refractory disease
D. For Chronic lymphocytic leukemia (CLL) Subjects:
* Subjects must have a histologically confirmed diagnosis of relapsed or refractory disease
* Must be at least 4 weeks since prior cytotoxic, biologic, monoclonal antibody, or investigational therapy, including corticosteroids
Exclusion Criteria:
A. Common to All indications:
* Prior anti-CXCR4 therapy including BMS-936564 (MDX-1338)
* Less than 3 months from prior hematopoietic stem cell transplant
* Presence of active graft versus host disease
B. For AML Subjects:
* Acute promyelocytic leukemia (M3)
* Left ventricular ejection fraction \< institutional limits of normal
C. For FL, DLBCL Subjects:
* (For DLBCL): Inadequate renal function defined as creatinine clearance (by Cockcroft-Gault formula) \< 60 mL/min
* Major surgery, not related to debulking procedures, within 21 days of first dose
* Myocardial infarction within 6 months prior to screening or Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia
* Myelodysplastic syndrome (MDS)
D. For CLL Subjects:
* No progression to more aggressive B-cell cancers, such as Richter's syndrome
* Major surgery within 21 days of Cycle 1, Day 1. Patients undergoing debulking procedures and minor surgery are allowed after a recovery period, in the judgment of the Investigator
* Myocardial infarction within 6 months prior to screening Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01120457
Study Brief:
Protocol Section:
NCT01120457