Clinical Study With Blinatumomab in Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)

Completed · Phase 2

Conditions studied: Acute Lymphoblastic Leukemia

In brief

The purpose of this study is to confirm whether the bispecific T cell engager antibody blinatumomab (MT103) is effective and safe in the treatment of patients with relapsed or refractory Acute Lymphoblastic Leukemia (ALL).

Key facts

Study ID

NCT01466179

Run by

Amgen Research (Munich) GmbH

People needed

225

Starts

2011-12-01

Expected to finish

2017-01-01

Last updated by the study team

2017-08-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with Philadelphia chromosome (Ph)-negative B-precursor ALL, with any of the following:
• relapsed or refractory with first remission duration less than or equal to 12 months in first salvage or
• relapsed or refractory after first salvage therapy or
• relapsed or refractory within 12 months of allogeneic hematopoietic stem cell transplantation (HSCT)
• 10% or more blasts in bone marrow
• In case of clinical signs of additional extramedullary disease: measurable disease
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• Age ≥ 18 years

You may not qualify if…

• Patients with Ph-positive ALL
• Patients with Burkitt's Leukemia according to World Health organization (WHO) classification
• History or presence of clinically relevant central nervous system (CNS) pathology
• Active ALL in the CNS or testes
• Current autoimmune disease or history of autoimmune disease with potential CNS involvement
• Autologous HSCT within six weeks prior to start of blinatumomab treatment
• Allogeneic HSCT within three months prior to start of blinatumomab treatment
• Any active acute graft versus-host disease (GvHD), or active chronic GvHD Grade 2 - 4
• Any systemic therapy against GvHD within two weeks prior to start of blinatumomab treatment
• Cancer chemotherapy within two weeks prior to start of blinatumomab treatment
• Radiotherapy within two weeks prior to start of blinatumomab treatment
• Immunotherapy (e.g., rituximab) within four weeks prior to start of blinatumomab treat-ment
• Any investigational anti-leukemic product within four weeks prior to start of blinatumomab treatment
• Treatment with any other investigational medicinal product (IMP) after signature of informed consent
• Eligibility for allogeneic HSCT at the time of enrollment
• Known hypersensitivity to immunoglobulins or to any other component of the IMP formulation
• Abnormal laboratory values indicative of inadequate renal or liver function
• History of malignancy requiring treatment other than ALL within five years prior to start of blinatumomab treatment with the exception of basal cell or squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix
• Any concurrent disease or medical condition that is deemed to interfere with the conduct of the study
• Infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus or hepatitis C virus
• Pregnant or nursing women
• Women of childbearing potential not willing to use an effective form of contraception. Male patients not willing to ensure not to beget a child
• Previous treatment with blinatumomab

Where it is running

• City of Hope — Duarte, California, United States
• University of California Los Angeles — Los Angeles, California, United States
• Winship Cancer Institute of Emory University — Atlanta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Dana Farber Institute — Boston, Massachusetts, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Roswell Park Cancer Streets — Buffalo, New York, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• CHU d'Angers — Angers, France
• Hôpital de l'hôtel Dieu — Nantes, France
• Hôpital Saint Louis — Paris, France
• CHU de Purpan — Toulouse, France
• Charité - Campus Benjamin Franklin — Berlin, Germany
• Klinikum der Goethe Universität, Medizinische Klinik II — Frankfurt, Germany
• Universitätsklinikum Freiburg — Freiburg im Breisgau, Germany
• Medizinische Hochschule Hannover — Hanover, Germany
• Universitätsklinikum Schleswig-Holstein — Kiel, Germany
• Universitätsklinikum Münster — Münster, Germany
• Universitätsklinikum Tübingen — Tübingen, Germany
• Universitätsklinikum Ulm — Ulm, Germany
• Julius-Maximilians-Universität, Medizinische Klinik und Poliklinik II — Würzburg, Germany

Full record on ClinicalTrials.gov

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