A Single-Arm Multicenter Phase II Study Preceded by Dose Evaluation to Investigate the Efficacy, Safety, and Tolerability of the BiTE® Antibody Blinatumomab (MT103) in Pediatric and Adolescent Patients With Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL)
Relapsed/refractory B-precursor ALL in pediatric and adolescent patients is an aggressive
malignant disease with dismal prognosis. Apart from allogeneic hematological stem cell
transplantation (HSCT) there is not any other curative treatment of second relapse or
refractory B-precursor ALL available. Additional therapeutic approaches are urgently needed.
Blinatumomab is a bispecific single-chain antibody construct designed to link B cells and T
cells resulting in T cell activation and a cytotoxic T cell response against CD19 expressing
cells. The purpose of this study is to investigate the pharmacokinetics, pharmacodynamics
and safety of escalating doses of the BiTE® antibody blinatumomab (MT103)in pediatric and
adolescent patients with relapsed/refractory B-precursor ALL, to select a dose and to
investigate the efficacy and safety of that dose of blinatumomab in above mentioned patient
population. Patients will receive up to five 6-weeks cycles (4 weeks of continuous
intravenous infusion followed by a 2-weeks treatment free interval) of blinatumomab
treatment.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase I part: Maximal tolerable dose
Maximal tolerable dose defined by <= 1 of 6 patients experiencing dose limiting toxicity or maximal administered dose
within 2 years
Yes
Arend von Stackelberg, MD
Study Chair
Charité Campus Virchow Klinikum
Germany: Paul-Ehrlich-Institut
MT103-205
NCT01471782
January 2012
July 2016
Name | Location |
---|---|
Children's Hospital of Philadelphia | Philadelphia, Pennsylvania 19104 |
Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio 45229-3039 |
Ut Southwestern Medical Center | Dallas, Texas 75390 |
Seattle Children's Hospital | Seattle, Washington 98105 |
Memorial Sloan Kettering | New York, New York 10021 |
St Jude Children's Research Hospital | Memphis, Tennessee 38105 |
Children's Healthcare of Atlanta at Egleston | Atlanta, Georgia 30322 |
Children's Hospital Denver | Denver, Colorado 80220 |
Texas Children's Cancer Center/ Baylor | Houston, Texas 77030-2399 |