First in Human Study to Determine the Safety, Tolerability and Preliminary Efficacy of an Anti-CXCR4 Antibody in Subjects With Acute Myelogenous Leukemia and Selected B-cell Cancers
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bristol-Myers Squibb
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
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)
You may not be if
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
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
Clareo Health | First in Human Study to Determine the Safety, Tolerability and Preliminary Efficacy of an Anti-CXCR4 Antibody in Subjects With Acute Myelogenous Leukemia and Selected B-cell Cancers
