An Open Label, Multicenter, Phase II Study to Evaluate Efficacy and Safety of the BiTE Antibody Blinatumomab in Adult Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)
Relapsed/refractory B-precursor ALL in adult patients is an aggressive malignant disease
with dismal prog-nosis. Several studies have reported long term survival to be below 10%.
Major prognostic factors are duration of first complete remission (CR1) and age. With
current salvage chemotherapy, complete remission (CR) rate is low (20 to 30%) in patients in
first salvage with short duration (< one year) of first remission, patients relapsed after
first salvage, or patients aged 60 years and older. Duration of CR is usually very short
(median disease free survival [DFS]: 2.0-7.5 months). Allogeneic hematopoietic stem cell
transplantation (HSCT) may provide a curative treatment option for patients in CR with a
satisfactory donor and appropriate clinical status including age, organ function, and
remission status. Allogeneic HSCT is not an option in most elderly patients with relapsed
ALL. Additional therapeutic approaches are urgently needed.
Blinatumomab (also termed MT 103) is a bispecific single-chain antibody derivative against
CD (cluster of differentiation)19 and CD3, designed to link B cells and T cells resulting in
T cell activation and a cytotoxic T cell response against CD19 expressing cells. In vitro
data indicate CD19+ lymphoma and leukemia cell lines to be extremely sensitive to
blinatumomab-mediated cytotoxicity.Blinatumomab has the potential to provide meaningful
therapeutic benefits to patients compared with existing treatments for this patient
population.
The purpose of this study is to confirm whether the bispecific T-cell engager blinatumomab
(MT103) is effective and safe in the treatment of patients with relapsed or refractory ALL.
Patients will receive up to five 4-week cycles of intravenous blinatumomab treatment.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
CR + CRh* rate
rate of complete remission and complete remission with partial hematologic recovery within in the first two treatment cycles
within 10 weeks
No
Nicola Gökbuget, MD
Principal Investigator
Klinikum der Goethe Universität Frankfurt
United States: Food and Drug Administration
MT103-211
NCT01466179
November 2011
June 2017
Name | Location |
---|---|
Mayo Clinic | Rochester, Minnesota 55905 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
Winship Cancer Institute of Emory University | Atlanta, Georgia 30322 |
City of Hope | Duarte, California 91010 |
University of California Los Angeles | Los Angeles, California 90095-6951 |
University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
University of Chicago | Chicago, Illinois 60637 |
University of Texas MD Anderson Cancer Center | Houston, Texas 77030 |
Dana Farber Institute | Boston, Massachusetts 02115 |
Roswell Park Cancer Streets | Buffalo, New York 14263 |