Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01471782
Other study ID # MT103-205
Secondary ID 2010-024264-18
Status Completed
Phase Phase 1/Phase 2
First received October 28, 2011
Last updated July 12, 2016
Start date January 2012
Est. completion date May 2016

Study information

Verified date July 2016
Source Amgen Research (Munich) GmbH
Contact n/a
Is FDA regulated No
Health authority Germany: Paul-Ehrlich-InstitutUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the dose of the bispecific T cell engager blinatumomab (MT103) in pediatric and adolescent patients with relapsed/refractory Acute Lymphoblastic Leukemia (ALL) and to assess whether this dose of blinatumomab is effective.


Description:

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 BiTEĀ® 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.


Recruitment information / eligibility

Status Completed
Enrollment 93
Est. completion date May 2016
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Both
Age group N/A to 17 Years
Eligibility Inclusion Criteria:

- Morphologic evidence of B-precursor ALL with > 25% blasts in bone marrow (M3)at study enrolment

- Age less than 18 years at enrollment

- Relapsed/refractory disease:

- Second or later bone marrow relapse,

- Any marrow relapse after allogeneic HSCT, or

- Refractory to other treatments: Patients in first relapse must have failed to achieve a CR following full standard reinduction chemotherapy regimen of at least 4 weeks duration.Patients who have not achieved a first remission must have failed a full standard induction regimen

- Karnofsky performance status more than or equal to 50% for patients more than or equal to 16 years and Lansky Performance Status (LPS) of more than or equal to 50% for patients less than 16 years

- Organ function requirements: All patients must have adequate renal and liver functions

Exclusion Criteria:

- Active acute or extensive chronic GvHD

- Immunosuppressive agents to prevent or treat GvHD within 2 weeks prior to blinatumomab treatment

- Evidence for current CNS involvement by ALL (CNS 2, CNS 3) or testicular involvement by ALL

- History of relevant CNS pathology or current relevant CNS pathology

- History of autoimmune disease with potential CNS involvement or current autoimmune disease

- Any HSCT within 3 months prior to blinatumomab treatment

- Cancer chemotherapy within 2 weeks prior to blinatumomab treatment (except for intrathecal chemotherapy and/or low dose maintenance therapy such as vinca alkaloids, mercaptopurine, methotrexate, glucocorticoids)

- Chemotherapy related toxicities that haven't resolved to less than or equal to Grade 2

- Radiotherapy within 2 weeks prior to blinatumomab treatment

- Immunotherapy (e.g. rituximab, alemtuzumab) within 6 weeks prior to blinatumomab treatment

- Any investigational product within 4 weeks prior to study entry

- Previous treatment with blinatumomab

- Active severe infection, any other concurrent disease or medical condition that could be exacerbated by the treatment or would seriously complicate compliance with the protocol

- Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HbsAg positive) or hepatitis C virus (anti-HCV positive)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
blinatumomab
intravenous infusion

Locations

Country Name City State
Austria St. Anna Kinderspital Vienna
Canada Hospital for Sick Children Toronto Ontario
France (CHU Besancon) Hopital Saint-Jaques Besancon
France Hôpital de la Timone (Enfants) Marseille
France Hopital Robert Debré (AP-HP) Paris Cedex 19
Germany Charité Campus Virchow Klinikum, Otto-Heubner-Centrum (OHC) für Kinder- und Jugendmedizin Berlin
Germany Universitätsklinikum Düsseldorf Düsseldorf
Germany Universitätsklinikum Essen Essen
Germany Klinikum der Johann Wolfgang Goethe-Universität Frankfurt/Main Frankfurt am Main
Germany Universitätsklinikum Hamburg-Eppendorf Hamburg
Germany Medizinische Hochschule Hannover Hannover
Germany Universitätsklinikum Schleswig-Holstein Campus Kiel Kiel
Germany Klinikum der Universität München, Dr. von Haunersches Kinderspital München
Germany Universitätsklinik für Kinder- und Jugendmedizin Tübingen Tübingen
Germany Universitätsklinikum Würzburg Würzburg
Italy University of Milano-Bicocca, Hospital San Gerardo Monza
Italy Dipartimento della Donna e del Bambino Padova
Italy The Bambino Gesù Children's Hospital Rome
Netherlands Erasmus MC, Sophia Children's Hospital Rotterdam
United States Children's Healthcare of Atlanta at Egleston Atlanta Georgia
United States Children's Hospital Denver Aurora Colorado
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio
United States UT Southwestern Medical Center Dallas Texas
United States Texas Children's Cancer Center/ Baylor Houston Texas
United States St Jude Children's Research Hospital Memphis Tennessee
United States Memorial Sloan Kettering New York New York
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania
United States Primary Children's Medical Center Salt Lake City Utah
United States Seattle Children's Hospital Seattle Washington
United States Washington University ST. Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Amgen Research (Munich) GmbH

Countries where clinical trial is conducted

United States,  Austria,  Canada,  France,  Germany,  Italy,  Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Phase II part: Rate of complete remission (CR) within 10 weeks No
Secondary Overall incidence and severity of adverse events within 3 years Yes
Secondary Proportion of patients who undergo allogeneic HSCT after treatment with blinatumomab within 2 years No
Secondary CR duration within 2 years No
Secondary Overall survival within 2 years No
Secondary Steady state concentration of blinatumomab (pharmacokinetics) within 2 years No
Secondary Cytokine serum concentrations within 2 years Yes
Secondary Time to hematological relapse within 2 years No
See also
  Status Clinical Trial Phase
Recruiting NCT05400122 - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer Phase 1
Recruiting NCT05772000 - Clinical Significance of Occult Central Nervous System Localization
Recruiting NCT05618041 - The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies N/A
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Active, not recruiting NCT03114865 - A Study of Blinatumomab in Patients With Pre B-cell ALL and B-cell NHL as Post-allo-HSCT Remission Maintenance Phase 1/Phase 2
Not yet recruiting NCT06308588 - Phase II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Phase 2
Recruiting NCT05579132 - A Phase Ib/II Study of CN201 in Precursor B-cell Acute Lymphoblastic Leukemia Phase 1/Phase 2
Recruiting NCT04904588 - HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide Phase 2
Terminated NCT02231853 - Phase I/II Trial of Early Infusion of Rapidly-generated Multivirus Specific T Cells (MVST) to Prevent Post Transplant Viral Infections Phase 1
Recruiting NCT04969601 - Anti-Covid-19 Vaccine in Children With Acute Leukemia and Their Siblings Phase 1/Phase 2
Recruiting NCT06195891 - Orca-T Following Chemotherapy and Total Marrow and Lymphoid Irradiation for the Treatment of Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia or Myelodysplastic Syndrome Phase 1
Withdrawn NCT02815059 - Study of Pts With Philadelphia Chromosome-Pos ALL With Comb of Ibrutinib, Dasatinib, and Prednisone Phase 1
Completed NCT00390793 - Combination Chemotherapy and Dasatinib in Treating Participants With Philadelphia Positive or BCR-ABL Positive Acute Lymphoblastic Leukemia. Phase 2
Recruiting NCT05866887 - Insomnia Prevention in Children With Acute Lymphoblastic Leukemia N/A
Completed NCT00026780 - Eligibility Screening for a NCI Pediatric Oncology Branch Research Study
Completed NCT04666025 - SARS-CoV-2 Donor-Recipient Immunity Transfer
Not yet recruiting NCT06350994 - Early Assessment of Cardiac Function After Treatment With CAR-T Cells
Withdrawn NCT04282174 - CD34+ Enriched Transplants From HLA-Compatible Patients With Hematologic Malignancies Phase 2
Not yet recruiting NCT04488237 - Vitamin D and Methotrexate Adverse Effects
Completed NCT02544438 - Study Evaluating the Safety and Efficacy of Astarabine in Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia Phase 1/Phase 2