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
Status: Recruiting
Phase: Phase 1
Diagnosis: Non-Hodgkin's Lymphoma
NCT ID: NCT01120457
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-288
The purpose of this study is to assess the safety and tolerability of BMS-936564 (MDX-1338) in relapsed/refractory selected B-cell cancers.
Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute, Beth-Israel Deaconess Medical Center
Overall PI:
Matthew Davids, MD,
Dana Farber Cancer Institute
Site-responsible Investigators:
Robin Joyce, MD,
Beth Israel Deaconess Medical Center
Contacts:
Dana-Farber Cancer Institute:
Karen Francoeur, 617-632-5849,
kalowe@partners.org
Beth-Israel Deaconess Medical Center:
Cancer Trials Call Center, 617-667-3060
Eligibility Criteria
Inclusion Criteria:
A. Common to All Indications:
- Life expectancy at least 12 weeks
- ECOG Performance Status of 0-2
B. 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
C. 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 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)
C. 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