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A Phase 1, Open-label, Multicenter Study of BMS-936564 (MDX-1338) in Subjects With Relapsed Acute Myelogenous Leukemia and Selected B-cell Malignancies


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Acute Myelogenous Leukemia, Diffuse Large B-Cell Leukemia, Chronic Lymphocytic Leukemia, Follicular Lymphoma

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Trial Information

A Phase 1, Open-label, Multicenter Study of BMS-936564 (MDX-1338) in Subjects With Relapsed Acute Myelogenous Leukemia and Selected B-cell Malignancies


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability as monotherapy

Outcome Description:

Safety and tolerability measured by incidence of adverse events (AEs), AEs leading to discontinuation, Serious Adverse Events (SAEs), deaths, and laboratory abnormalities

Outcome Time Frame:

Within the first 7 days for AML

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA212-001

NCT ID:

NCT01120457

Start Date:

August 2010

Completion Date:

September 2013

Related Keywords:

  • Acute Myelogenous Leukemia
  • Diffuse Large B-Cell Leukemia
  • Chronic Lymphocytic Leukemia
  • Follicular Lymphoma
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, B-Cell
  • Leukemia, Lymphoid
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Lymphoma
  • Lymphoma, Follicular

Name

Location

University of Washington School of MedicineSeattle, Washington  98195
Moores UCSD Cancer CenterLa Jolla, California  92093-0658
UAB Comprehensive Cancer CenterBirmingham, Alabama  35294
Local InstitutionSpringfield, Massachusetts  
The University of Texas MD Anderson Cancer CenterHouston, Texas  77030-4009
Ucla-Division Of Hematology/OncologyLos Angeles, California  90095
Usc - Norris Comprehensive Cancer Center And HospitalLos Angeles, California  90033
B. Douglas Smith, M.D.Baltimore, Maryland  21287