History of Changes for Study: NCT01466179

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

A study version is represented by a row in the table.
Select two study versions to compare. One each from columns A and B.
Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
Click "Compare" to do the comparison and show the differences.
Select a version's Submitted Date link to see a rendering of the study for that version.
The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
Hover over the "Recruitment Status" to see how the study's recruitment status changed.
Study edits or deletions are displayed in red.
Study additions are displayed in green.

Study Record Versions

Version	Submitted Date	Changes
1	November 4, 2011	None (earliest Version on record)
2	November 28, 2011	Recruitment Status, Contacts/Locations, Study Status and Oversight
3	December 8, 2011	Study Status and Contacts/Locations
4	December 23, 2011	Contacts/Locations and Study Status
5	February 3, 2012	Contacts/Locations and Study Status
6	February 29, 2012	Contacts/Locations and Study Status
7	November 28, 2012	Contacts/Locations, Arms and Interventions, Study Design, Study Status and Study Identification
8	January 4, 2013	Contacts/Locations, Study Status, Outcome Measures, Eligibility and Study Design
9	April 10, 2013	Contacts/Locations and Study Status
10	July 11, 2013	Contacts/Locations and Study Status
11	November 20, 2013	Recruitment Status, Study Status and Contacts/Locations
12	October 31, 2014	Study Status and Study Design
13	January 20, 2015	Study Status, Outcome Measures, Arms and Interventions, Results, Eligibility, Study Description and Study Identification
14	July 12, 2016	Study Status
15	July 18, 2017	Recruitment Status, Study Status and Contacts/Locations

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	MT103-211
Brief Title:	Clinical Study With Blinatumomab in Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)
Official Title:	An Open Label, Multicenter, Phase II Study to Evaluate Efficacy and Safety of the BiTE Antibody Blinatumomab in Adult Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)
Secondary IDs:	2011-002257-61 [EudraCT Number]

Study Status


Record Verification:	November 2011
Overall Status:	Not yet recruiting
Study Start:	November 2011
Primary Completion:	March 2013 [Anticipated]
Study Completion:	August 2015 [Anticipated]

First Submitted:	October 28, 2011
First Submitted that Met QC Criteria:	November 4, 2011
First Posted:	November 6, 2011 [Estimate]

Last Update Submitted that Met QC Criteria:	November 4, 2011
Last Update Posted:	November 6, 2011 [Estimate]

Sponsor/Collaborators


Sponsor:	Amgen Research (Munich) GmbH
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:	Yes

Study Description

Brief Summary:

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).

Detailed Description:

Relapsed/refractory B-precursor ALL in adult patients is an aggressive malignant disease with dismal prog-nosis. Several studies have reported long term survival to be below 10%. Major prognostic factors are duration of first complete remission (CR1) and age. With current salvage chemotherapy, complete remission (CR) rate is low (20 to 30%) in patients in first salvage with short duration (< one year) of first remission, patients relapsed after first salvage, or patients aged 60 years and older. Duration of CR is usually very short (median disease free survival [DFS]: 2.0-7.5 months). Allogeneic hematopoietic stem cell transplantation (HSCT) may provide a curative treatment option for patients in CR with a satisfactory donor and appropriate clinical status including age, organ function, and remission status. Allogeneic HSCT is not an option in most elderly patients with relapsed ALL. Additional therapeutic approaches are urgently needed.

Blinatumomab (also termed MT 103) is a bispecific single-chain antibody derivative against CD (cluster of differentiation)19 and CD3, designed to link B cells and T cells resulting in T cell activation and a cytotoxic T cell response against CD19 expressing cells. In vitro data indicate CD19+ lymphoma and leukemia cell lines to be extremely sensitive to blinatumomab-mediated cytotoxicity.Blinatumomab has the potential to provide meaningful therapeutic benefits to patients compared with existing treatments for this patient population.

The purpose of this study is to confirm whether the bispecific T-cell engager blinatumomab (MT103) is effective and safe in the treatment of patients with relapsed or refractory ALL. Patients will receive up to five 4-week cycles of intravenous blinatumomab treatment.

Conditions


Conditions:	Acute Lymphoblastic Leukemia
Keywords:	B-ALL relapsed ALL refractory ALL adult ALL Leukemia Leukemia, Lymphoid precursor cell lymphoblastic leukemia-lymphoma Lymphatic diseases Lymphoproliferative disorders bispecific antibody anti-CD19 Immunotherapeutic treatment immunoproliferative disorders

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 2
Interventional Study Model:	Single Group Assignment
Number of Arms:	1
Masking:	None (Open Label)
Allocation:	N/A
Enrollment:	61 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Blinatumomab Bispecific T cell engager antibody	Drug: Blinatumomab continuous intravenous infusion over four weeks per treatment cycle Other Names: MT103

Outcome Measures


Primary Outcome Measures:
1.	CR + CRh* rate [ Time Frame: within 10 weeks ] rate of complete remission and complete remission with partial hematologic recovery within in the first two treatment cycles
Secondary Outcome Measures:
1.	Proportion of patients eligible for allogeneic hematopoietic stem cell transplantation (HSCT) who undergo the procedure after treatment with blinatumomab [ Time Frame: within 17 months ]
2.	CR rate [ Time Frame: within 10 weeks ]
3.	CRh* rate [ Time Frame: within 10 weeks ]
4.	Partial remission (PR) rate [ Time Frame: within 10 weeks ]
5.	Relapse-free survival [ Time Frame: up to 4 years ]
6.	Overall survival [ Time Frame: up to 4 years ]
7.	Number of AEs per patient [ Time Frame: up to 8 months ]
8.	100-day mortality after allogeneic HSCT [ Time Frame: within 4 years ]
9.	Steady state concentration of blinatumomab (pharmacokinetics) [ Time Frame: within 10 weeks ]
10.	Serum cytokine concentrations [ Time Frame: up to 2 years ]
11.	Rate of MRD response [ Time Frame: within 10 weeks ]
12.	Rate of MRD complete response [ Time Frame: within 10 weeks ]
13.	Duration of CR and CRh* [ Time Frame: up to 4 years ]

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Patients with 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 HSCT 10% or more blasts in bone marrow In case of clinical signs of additional extramedullary disease: measurable disease ECOG performance status ≤ 2 Age ≥ 18 years Exclusion Criteria: Patients with Ph-positive ALL History or presence of clinically relevant 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 GvHD, or active chronic GvHD Grade 2 - 4 Immunosuppressive 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 four 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 IMP after signature of informed consent Known hypersensitivity to immunoglobulins or to any other component of the IMP formulation Abnormal laboratory values indicative of inadequate renal or liver function Active malignancy requiring treatment other than ALL within two 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 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

Contacts/Locations


Central Contact Person:	Gerhard Zugmaier, MD Telephone: +49 - 89 - 89 5277 Ext. 335 Email: clinicaltrials@micromet.com
Central Contact Backup:	Birgit Huber, PhD Telephone: +49 - 89 - 89 5277 Ext. 347 Email: clinicaltrials@micromet.com
Locations:	United States, California
	City of Hope Duarte, California, United States, 91010-3000
	University of California Los Angeles Los Angeles, California, United States, 90095-1678
	United States, Georgia
	Winship Cancer Institute of Emory University Atlanta, Georgia, United States, 30322
	United States, Illinois
	Rush University Medical Center Chicago, Illinois, United States, 60612
	University of Chicago Chicago, Illinois, United States, 60637
	United States, Massachusetts
	Dana Farber Institute Boston, Massachusetts, United States, 02215
	United States, Michigan
	Barbara Ann Karmanos Cancer Institute Detroit, Michigan, United States, 48201
	United States, Minnesota
	Mayo Clinic Rochester, Minnesota, United States, 55905
	United States, Missouri
	Washington University School of Medicine St. Louis, Missouri, United States, 63110
	United States, Nebraska
	University of Nebraska Medical Center Omaha, Nebraska, United States, 68198-7680
	United States, New Jersey
	John Theurer Cancer Center at Hackensack Univeristy Medical Center Hackensack, New Jersey, United States, 07601
	United States, New York
	Roswell Park Cancer Streets Buffalo, New York, United States, 14263
	United States, North Carolina
	Wake Forest Baptist Health Winston-Salem, North Carolina, United States, 27157-1082
	United States, Pennsylvania
	University of Pennsylvania Philadelphia, Pennsylvania, United States, 19104
	United States, Texas
	University of Texas MDACC Houston, Texas, United States, 77030
	United States, Washington
	Seattle Cancer Care Alliance Seattle, Washington, United States, 98109
	France
	CHU d'Angers Angers, France, 49933
	Hôpital de l'hôtel Dieu Nantes, France, 44000
	Hôpital Saint Louis Paris, France, 75475
	CHU de Purpan Toulouse, France, 31059
	Germany
	Charité - Campus Benjamin Franklin Berlin, Germany, 12200
	Klinikum der Goethe Universität, Medizinische Klinik II Frankfurt, Germany, 60590
	Universitätsklinikum Freiburg Freiburg, Germany, 79106
	Medizinische Hochschule Hannover Hannover, Germany, 30625
	Universitätsklinikum Schleswig-Holstein Kiel, Germany, 24116
	Universitätsklinikum Münster Münster, Germany, 48149
	Universitätsklinikum Tübingen Tübingen, Germany, 72076
	Universitätsklinikum Ulm Ulm, Germany, 89081
	Julius-Maximilians-Universität, Medizinische Klinik und Poliklinik II Würzburg, Germany, 97080
	Italy
	Ospedali Riuniti di Bergamo Bergamo, Italy, 24128
	Azienda Ospedaliera Antonio Cardarelli Naples, Italy, 80131
	Ospedali Riuniti "Villa Sofia-Cervello" Palermo, Italy, 90100
	Università La Sapienza di Roma Rome, Italy, 00161
	Azienda Ospedaliero-Universitaria Turin, Italy, 10100
	Azienda Ospedaliera di Verona Verona, Italy, 37134
	Spain
	ICO Hospital Germans Trias I Pujol Badalona, Spain, 08916
	Hospital Clínic Servei d´Hematologia Barcelona, Spain, 08036
	Hospital 12 de Octubre Madrid, Spain, 28041
	Hospital universitario de Salamanca Salamanca, Spain, 37007
	Hospital Universitario Virgen Del Rocio Sevilla, Spain, 41013
	United Kingdom
	University Hospitals Bristol NHS Bristol, United Kingdom, BS2 8ED
	Royal Free Hampstead NHS Trust London, United Kingdom, NW3 2QG
	The Christie NHS Foundation Trust Manchester, United Kingdom, M20 4BX
	The Freeman Hospital Newcastle, United Kingdom, NE7 7DN
	Nottingham University Hospital NHS Trust Nottingham, United Kingdom, NG5 1PB

IPDSharing


Plan to Share IPD:

References


Links:
Available IPD/Information: