Clinical Study With Blinatumomab in Pediatric and Adolescent Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia

This study is currently recruiting participants.
Verified November 2013 by Amgen Research (Munich) GmbH
Sponsor:
Information provided by (Responsible Party):
Amgen Research (Munich) GmbH
ClinicalTrials.gov Identifier:
NCT01471782
First received: October 28, 2011
Last updated: November 20, 2013
Last verified: November 2013

October 28, 2011
November 20, 2013
January 2012
October 2014   (final data collection date for primary outcome measure)
  • Phase I part: Maximal tolerable dose [ Time Frame: within 2 years ] [ Designated as safety issue: Yes ]
    Maximal tolerable dose defined by <= 1 of 6 patients experiencing dose limiting toxicity or maximal administered dose
  • Phase II part: Rate of complete remission (CR) [ Time Frame: within 10 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01471782 on ClinicalTrials.gov Archive Site
  • Overall incidence and severity of adverse events [ Time Frame: within 3 years ] [ Designated as safety issue: Yes ]
  • Proportion of patients who undergo allogeneic HSCT after treatment with blinatumomab [ Time Frame: within 2 years ] [ Designated as safety issue: No ]
  • CR duration [ Time Frame: within 2 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: within 2 years ] [ Designated as safety issue: No ]
  • Steady state concentration of blinatumomab (pharmacokinetics) [ Time Frame: within 2 years ] [ Designated as safety issue: No ]
  • Cytokine serum concentrations [ Time Frame: within 2 years ] [ Designated as safety issue: Yes ]
  • Time to hematological relapse [ Time Frame: within 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Clinical Study With Blinatumomab in Pediatric and Adolescent Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia
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)

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.

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
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Lymphoblastic Leukemia
Drug: blinatumomab
intravenous infusion
Other Names:
  • MT103
  • AMG103
Experimental: blinatumomab
Intervention: Drug: blinatumomab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
84
July 2016
October 2014   (final data collection date for primary outcome measure)

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)
Both
up to 17 Years
No
Not Provided
United States,   Austria,   Canada,   France,   Germany,   Italy,   Netherlands
 
NCT01471782
MT103-205, 2010-024264-18
Yes
Amgen Research (Munich) GmbH
Amgen Research (Munich) GmbH
Not Provided
Study Chair: Arend von Stackelberg, MD Charité Campus Virchow Klinikum
Study Chair: Lia Gore, MD Children's Hospital Denver, USA
Amgen Research (Munich) GmbH
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP