Clinical Study With Blinatumomab in Pediatric and Adolescent Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia
This study is currently recruiting participants.
Verified January 2013 by Amgen Research (Munich) GmbH
Sponsor:
Amgen Research (Munich) GmbH
Information provided by (Responsible Party):
Amgen Research (Munich) GmbH
ClinicalTrials.gov Identifier:
NCT01471782
First received: October 28, 2011
Last updated: January 2, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Lymphoblastic Leukemia |
Drug: blinatumomab |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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) |
Resource links provided by NLM:
Further study details as provided by Amgen Research (Munich) GmbH:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 84 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | July 2016 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: blinatumomab |
Drug: blinatumomab
intravenous infusion
Other Names:
|
Detailed 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 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.
Eligibility| Ages Eligible for Study: | up to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01471782
Locations
| United States, Colorado | |
| Children's Hospital Denver | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Lia Gore, MD lia.gore@ucdenver.edu | |
| United States, Georgia | |
| Children's Healthcare of Atlanta at Egleston | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: todd M Cooper, MD todd.cooper@choa.org | |
| United States, New York | |
| Memorial Sloan Kettering | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Tanya M Trippet, MD trippet1@mskcc.org | |
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | Recruiting |
| Cincinnati, Ohio, United States, 45229 | |
| Contact: Maureen O'Brien, MD maureen.obrien@cchmc.org | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Susan R Rheingold, MD rheingold@email.chop.edu | |
| United States, Tennessee | |
| St Jude Children's Research Hospital | Recruiting |
| Memphis, Tennessee, United States, 38105-3678 | |
| Contact: Deepa Bhojwani, MD Deepa.Bhojwani@stjude.org | |
| United States, Texas | |
| UT Southwestern Medical Center | Recruiting |
| Dallas, Texas, United States, 75390-9063 | |
| Contact: Naomi J Winick, MD naomi.winick@utsouthwestern.edu | |
| Texas Children's Cancer Center/ Baylor | Recruiting |
| Houston, Texas, United States, 77030-2399 | |
| Contact: Terzah M Horton, MD tmhorton@txccc.org | |
| United States, Washington | |
| Seattle Children's Hospital | Not yet recruiting |
| Seattle, Washington, United States, 98105 | |
| Austria | |
| St. Anna Kinderspital | Recruiting |
| Vienna, Austria, 1090 | |
| Contact: Christina Peters, MD +43 1 40 170 3106 christina.peters@stanna.at | |
| Canada, Ontario | |
| Hospital for Sick Children | Not yet recruiting |
| Toronto, Ontario, Canada, M5G1X8 | |
| France | |
| (CHU Besancon) Hopital Saint-Jaques | Not yet recruiting |
| Besancon, France, 25030 | |
| Contact: Pierre Simon Rohrlich, MD +33-3-8121 ext 8138 prohrlich@chu-besancon.fr | |
| Hopital Robert Debré (AP-HP) | Recruiting |
| Paris Cedex 19, France, 75935 | |
| Contact: Benoit Brethon, MD benoit.brethon@rdb.aphp.fr | |
| Germany | |
| Charité Campus Virchow Klinikum, Otto-Heubner-Centrum (OHC) für Kinder- und Jugendmedizin | Recruiting |
| Berlin, Germany, 13353 | |
| Contact: Arend von Stackelberg, MD +49-30-450666 ext 833 arend.stackelberg@charite.de | |
| Universitätsklinikum Düsseldorf | Recruiting |
| Düsseldorf, Germany, 40225 | |
| Contact: Arndt Borkhardt, MD +49-211-8117 ext 680 arndt.borkhardt@med.uni-duesseldorf.de | |
| Klinikum der Johann Wolfgang Goethe-Universität Frankfurt/Main | Recruiting |
| Frankfurt am Main, Germany, 60590 | |
| Contact: Peter Bader, Prof. +49 69 (0) 6301 7542 peter.bader@kgu.de | |
| Klinikum der Universität München, Dr. von Haunersches Kinderspital | Recruiting |
| München, Germany, 80337 | |
| Contact: Michael Albert, MD +49-89-5160 ext 2811 michael.albert@med.uni-muenchen.de | |
| Universitätsklinik für Kinder- und Jugendmedizin Tübingen | Recruiting |
| Tübingen, Germany, 72076 | |
| Contact: Rupert Handgretinger, MD +49-7071-2984 ext 744 rupert.handgretinger@med.uni-tuebingen.de | |
| Italy | |
| University of Milano-Bicocca, Hospital San Gerardo | Recruiting |
| Monza, Italy, 20052 | |
| Contact: Carmelo Rizzari, MD c.rizzari@hsgerardo.org | |
| The Bambino Gesù Children's Hospital | Recruiting |
| Rome, Italy, 00165 | |
| Contact: Franco Locatelli, MD +39668592678 franco.locatelli@opbg.net | |
| Netherlands | |
| Erasmus MC, Sophia Children's Hospital | Recruiting |
| Rotterdam, Netherlands, 3015 GJ | |
| Contact: Christian M Zwaan, MD c.m.zwaan@erasmusmc.nl | |
Sponsors and Collaborators
Amgen Research (Munich) GmbH
Investigators
| Study Chair: | Arend von Stackelberg, MD | Charité Campus Virchow Klinikum |
| Study Chair: | Lia Gore, MD | Children's Hospital Denver, USA |
More Information
No publications provided
| Responsible Party: | Amgen Research (Munich) GmbH |
| ClinicalTrials.gov Identifier: | NCT01471782 History of Changes |
| Other Study ID Numbers: | MT103-205, 2010-024264-18 |
| Study First Received: | October 28, 2011 |
| Last Updated: | January 2, 2013 |
| Health Authority: | Germany: Paul-Ehrlich-Institut United States: Food and Drug Administration |
Keywords provided by Amgen Research (Munich) GmbH:
|
ALL relapsed, refractory B-precursor ALL Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia Neoplasms by Histologic Type |
Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Antibodies, Bispecific |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Antibodies, Bispecific Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013