T2009-007: A Phase I Study Evaluating the Safety, Tolerability and Biological Activity of EZN-3042, a Survivin mRNA Antagonist, Administered With Re-induction Chemotherapy in Children With Relapsed Acute Lymphoblastic Leukemia (ALL) [IND 108753]
This is a phase I multi-site study of the new investigational agent EZN-3042, which is
highly effective at blocking survivin and inhibiting survivin protein expression. Survivin
plays pivotal roles in tumor formation by inhibiting cell death and regulating cell cycle
progression. The primary objective is to study EZN-3042 in children with relapsed acute
lymphoblastic leukemia (ALL). Patients will receive 2 doses of EZN-3042 prior to initiating
systemic therapy with vincristine, doxorubicin, prednisone and PEG-asparaginase. In
addition, blood and bone marrow specimens will be drawn to measure minimal residual disease
(MRD), pharmacokinetic levels of EZN-3042 and survivan expression. The study will follow a
standard 3+3 dose escalation design. We hypothesize that EZN-3042 will be safe, tolerable
and biologically active, when given both alone and in combination with standard re-induction
chemotherapy.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the safety and tolerability of administering EZN-3042 as a single agent and in combination with chemotherapy, for children with relapsed B-precursor acute lymphoblastic leukemia (ALL)
1.5 months
Yes
Elizabeth Raetz, MD
Study Chair
New York University School of Medicine
United States: Food and Drug Administration
T2009-007
NCT01186328
August 2010
June 2012
Name | Location |
---|---|
Johns Hopkins University | Baltimore, Maryland 21205 |
Stanford University Medical Center | Stanford, California 94305-5408 |
Phoenix Children's Hospital | Phoenix, Arizona 85016-7710 |
Childrens Hospital Los Angeles | Los Angeles, California 90027 |
Vanderbilt Children's Hospital | Nashville, Tennessee 37232-6310 |
City of Hope | Duarte, California 91010 |
New York University Medical Center | New York, New York 10016 |
Oregon Health and Science University | Portland, Oregon 97201 |
Seattle Children's Hospital | Seattle, Washington 98105 |
Dana Farber | Boston, Massachusetts 02115-6084 |
UCSF School of Medicine | San Francisco, California 94143-0106 |
C.S. Mott Children's Hospital | Ann Arbor, Michigan 48109-0914 |
Childrens Hospital & Clinics of Minnesota | Minneapolis, Minnesota 55404-4597 |
Children's Hospital New York-Presbyterian | New York, New York 10032 |
Miller Children's Hospital | Long Beach, California 90806 |
Children's Memorial | Chicago, Illinois 60614 |
Oakland Children's Hospital | Oakland, California |
University of Minnesota Children's Hospital | Minneapolis, Minnesota |
Nationwide Childrens Hospital | Columbus, Ohio |
Children's Healthcare of Atlanta, Emory University | Atlanta, Georgia |
St. Jude | Memphis, Tennessee 38105-3678 |