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Confirmatory Phase II Study of Blinatumomab (MT103) in Patients With Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia (ALL) (BLAST)

Primary Purpose

B-cell Acute Lymphoblastic Leukemia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Blinatumomab
Sponsored by
Amgen Research (Munich) GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B-cell Acute Lymphoblastic Leukemia focused on measuring Blinatumomab, MRD, B-ALL, Minimal residual disease, adult ALL, Leukemia, ALL, Lymphatic diseases, Lymphoproliferative disorders, bispecific antibody, anti-CD19, Immunotherapeutic treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with B-precursor ALL in complete hematological remission after at least 3 intense chemotherapy blocks
  • Presence of minimal residual disease at a level of ≥ 10^-3
  • Availability of bone marrow specimen from primary diagnosis for clone-specific MRD assessment
  • Negative human immunodeficiency virus (HIV) test, negative hepatitis B (HbsAg) test and hepatitis C virus (anti-HCV) test
  • Negative pregnancy test in women of childbearing potential
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria:

  • Presence of circulating blasts or current extra-medullary involvement by ALL
  • History of relevant central nervous system (CNS) pathology or current CNS pathology
  • Prior allogeneic hematopoietic stem cell transplant (HSCT)
  • Eligibility for treatment with tyrosine-kinase inhibitors (TKI)
  • Systemic cancer chemotherapy within 2 weeks prior to study treatment
  • Therapy with monoclonal antibodies (rituximab, alemtuzumab) within 4 weeks prior to study treatment
  • Previous treatment with blinatumomab

Sites / Locations

  • 1102 - LKH Graz
  • 1107 - Krankenhaus der Elisabethinen
  • 1106
  • 1101 - AKH Wien
  • 1504
  • 1502 - Cliniques Universitaires de Saint-Luc
  • 1505
  • 1503
  • 1501 - Cliniques Universitaires UCL de Mont Godinne
  • 1211 - CHU d'Angers
  • 1210 - CHU de Besançon
  • 1206 - Hôpital de Pontoise
  • 1205 - CHU Henri Mondor
  • 1209 - CHU de Lyon
  • 1212 - Hôpital de l'hôtel Dieu
  • 1213 - Centre Hospitalier Universitaire de Nice
  • 1201 - Hôpital Saint Louis
  • 1202 - CHU de Bordeaux - Hôpital Haut Lévêque
  • 1208 - CHU de Purpan
  • 1011 - Charité Berlin
  • 1022 - Universitätsklinkum Carl Gustav Carus Dresden
  • 1009 - Universitätsklinikum Essen
  • 1002 - Klinikum der Goethe Universität
  • 1014 - Asklepiosklinik St. Georg
  • 1018 - Medizinische Hochschule Hannover
  • 1012 - Universitätsklinikum Heidelberg
  • 1003 - Universitätsklinikum Schleswig-Holstein
  • 1019 - Universitätsklinikum Leipzig
  • 1010 - Klinikum der Universität München - Großhadern
  • 1004 - Universitätsklinikum Münster
  • 1016 - Universitätsklinikum Regensburg
  • 1020 - Universitätsklinikum Rostock
  • 1007 - Robert-Bosch-Krankenhaus
  • 1015 - Universitätsklinikum Tübingen
  • 1005 - Universitätsklinikum Ulm
  • 1001 - Julius-Maximilians-Universität Würzburg
  • 1301 - Ospedali Riuniti di Bergamo
  • 1303 - Istituto di Ematologia "L.& A.Seràgnoli" Azienda
  • 1314 - Azienda Ospedaliera Spedali Civili Brescia
  • 1313 - Universita di Catania
  • 1312 - Azienda Ospedaliera Universitaria San Martino
  • 1305 - Ospedale San Gerardo
  • 1309 - Azienda Ospedaliera Antonio Cardarelli
  • 1308 - Ospedali Riuniti "Villa Sofia-Cervello"
  • 1302 - Università La Sapienza di Roma
  • 1310 - Fondazione Policlinico Tor Vergata
  • 1315 - Azienda Ospedaliero-Universitaria S. Giovanni Battista (Le Molinette)
  • 1311 - Azienda Ospedaliera di Verona
  • 2204 - UMC Groningen
  • 2201 - Daniel Den Hoed Hospitaal
  • 1905 - Uniwersytecki Szpital Kliniczny w Białymstoku
  • 1907 - Uniwersyteckie Centrum Kliniczne
  • 1908 - Swietokrzyskie Centrum Onkologii
  • 1902 - Uniwersytet Medyczny w Lublinie
  • 1901 - Klinika Hematologii - Instytut Hematologii i Transfuzjologii
  • 1906 - MTZ Clinical Research Sp. z o.o.
  • 1904 - Samodzielny Publiczny
  • 2101 - Institutul Clinic Fundeni, Hematologie II
  • 2102 - Spitalul Clinic Coltea, Hematologie
  • 2106 - Institutul Oncologic "Prof. Dr. I. Chiricuta"
  • 2105 - Institutul Regional de Oncologie
  • 2001 - Russian Hematology Research Center
  • 2003 - Municipal Hospital No. 15
  • 1401 - ICO Hospital Germans Trias I Pujol
  • 1404 - Hospital Clínic Servei d´Hematologia
  • 1402 - Complexo Hospitalario Universitario A Coruña
  • 1408 - Hospital 12 de Octubre
  • 1405 - Hospital Universitari Son Espases
  • 1407 - Unidad de Citogenética Oncológica
  • 1406 - Hospital Universitari i Politècnic La Fe de Valencia
  • 1605 - Queen Elizabeth Hospital
  • 1602 - Bristol Royal Infirmary
  • 1604 - University Hospital of Wales
  • 1601 - Royal Free Hospital
  • 1607 - Nottingham City Hospital NHS Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Blinatumomab

Arm Description

Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.

Outcomes

Primary Outcome Measures

Percentage of Participants With a Minimal Residual Disease (MRD) Response Within the First Treatment Cycle
At the end of the first treatment cycle (Day 29) a bone marrow aspiration/biopsy was performed and evaluated by the central MRD laboratory. Complete MRD response is defined as no polymerase chain reaction (PCR) amplification of individual rearrangements of immunoglobulin (Ig)- or T-cell receptor (TCR)-genes detected after completion of the first cycle.

Secondary Outcome Measures

Hematological Relapse-free Survival (RFS)
Hematological RFS was measured from first dose of blinatumomab until the first assessment of documented relapse (either hematological or extramedullary), secondary leukemia, or death due to any cause. Participants without a documented relapse, or death due to any cause were censored at the time of their last hematological assessment. Participants who received chemotherapy for relapsed or persistent MRD or for any other reason after treatment with blinatumomab, or HSCT after treatment with blinatumomab, before hematological or extramedullary relapse, or death occurred were censored at the start of chemotherapy or HSCT, respectively. Hematological relapse was defined as unequivocal detection of > 5% leukemia cells in bone marrow as measured by cytological, microscopic assessment, presence of circulating leukemia blasts, or extramedullary leukemia (whichever occurred first). The 18-month Kaplan-Meier estimate of hematological RFS is reported.
Overall Survival
Overall survival was measured from the first treatment with blinatumomab until death due to any cause. Participants who did not die were censored at their last contact date.
100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplant
The mortality rate within 100 days after allogeneic HSCT was defined as the Kaplan-Meier estimate of the percentage of participants dying within 100 days after the day of the first allogeneic HSCT.
Time to Hematological Relapse
Time to hematological relapse was measured from the start of treatment with blinatumomab until hematological or extramedullary relapse. Participants who died or received HSCT or post-blinatumomab chemotherapy after treatment with blinatumomab were censored at their last hematological assessment prior to death or HSCT or post-blinatumomab chemotherapy (whichever occurred first).
Duration of Complete MRD Response
The duration of MRD response was analyzed as the time from onset of MRD negativity until MRD or hematological relapse or date of last confirmation of negative MRD status. Participants who received chemotherapy or HSCT after treatment with blinatumomab, before hematological or extramedullary relapse were censored at the start of chemotherapy or HSCT, respectively. MRD relapse is defined as the reappearance of individual rearrangements of Ig- or TCR-genes ≥ lower limit of quantification (LLOQ) for at least 1 individual marker measured by an assay with a sensitivity of minimum 10^-4. Hematological relapse is defined as the unequivocal detection of > 5% leukemia cells in bone marrow as measured by cytological or microscopic assessment, presence of circulating leukemia blasts, or extramedullary leukemia.
Change in MRD Level From Baseline to End of Cycle 1 in Non-MRD Responders
MRD level was measured by polymerase chain reaction (PCR) performed on bone marrow and assessed by the central laboratory. An MRD level of 10^-n corresponds to residual leukemia cells at a frequency of 1 per 10ⁿ bone marrow cells.
Number of Participants With Adverse Events
Adverse events (AEs) were evaluated for severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4, as follows: Grade 1 - Mild AE; Grade 2 - Moderate AE; Grade 3 - Severe AE; Grade 4 - Life-threatening or disabling AE; Grade 5 - Death. The investigator used medical judgment to determine if there was a causal relationship (ie, related, unrelated) between an adverse event and blinatumomab. An AE was considered "serious" if it resulted in death, was life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant incapacity or substantial disruption to conduct normal life functions, was a congenital anomaly or birth defect or was a medically important condition.
Change From Baseline in EORTC-QLQ-C30 Scales
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Insomnia, Appetite Loss, Constipation, Diarrhea, Financial Impact). For each of these scales, scores range from 0 to 100. For the GHS and 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement. For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms. The maximum changes from baseline to cycles 1 through 4 and the change from baseline to the end of the core study are reported.
Change From Baseline in EuroQoL 5-Dimension (EQ-5D) Scales
The EQ-5D is a self-administered questionnaire which captures 3 basic types of information: a descriptive profile (health state index) and the overall health rating using a visual analog scale. The health state index measures mobility, self-care, usual activities, pain/discomfort and anxiety/depression on scales from no problems (score = 1), some problems (score = 2), to extreme problems (score = 3). For each dimension the mean change from baseline was calculated at the end of each treatment cycle and at the end of the core study. The maximum observed change from baseline during cycles 1 to 4 and the change from baseline at the end of the core study are reported for each dimension.
Resource Utilization: Number of Participants Reporting Use of Transfusion of Blood Products
Resource Utilization: Duration of Hospitalization

Full Information

First Posted
September 21, 2010
Last Updated
January 31, 2020
Sponsor
Amgen Research (Munich) GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01207388
Brief Title
Confirmatory Phase II Study of Blinatumomab (MT103) in Patients With Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia (ALL)
Acronym
BLAST
Official Title
A Confirmatory Multicenter, Single-arm Study to Assess the Efficacy, Safety, and Tolerability of the BiTE® Antibody Blinatumomab in Adult Patients With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (BLAST)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
January 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen Research (Munich) GmbH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to confirm whether the bispecific T cell engager blinatumomab (MT103) is effective, safe and tolerable in the treatment of ALL patients with minimal residual disease.
Detailed Description
The detection of minimal residual disease (MRD) after induction therapy and/or consolidation therapy is an independent prognostic factor for poor outcome of adult ALL. No standard treatments are available for patients with MRD-positive B-precursor ALL. Blinatumomab (MT103) 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 cluster of differentiation (CD)19 expressing cells. The purpose of this study is to confirm whether the bispecific T-cell engager blinatumomab (MT103) is effective, safe and tolerable in the treatment of ALL patients with minimal residual disease. Participants will receive up to four 4-week cycles of intravenous blinatumomab treatment followed by an infusion-free period of 14 days. A safety follow-up will be performed 30 days after the end of the last infusion and efficacy follow-ups will occur until 24 months after treatment start. Participants will be followed for up to 5 years after the start of treatment for survival.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-cell Acute Lymphoblastic Leukemia
Keywords
Blinatumomab, MRD, B-ALL, Minimal residual disease, adult ALL, Leukemia, ALL, Lymphatic diseases, Lymphoproliferative disorders, bispecific antibody, anti-CD19, Immunotherapeutic treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blinatumomab
Arm Type
Experimental
Arm Description
Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
Intervention Type
Drug
Intervention Name(s)
Blinatumomab
Other Intervention Name(s)
AMG 103, MT103, BLINCYTO™
Intervention Description
Continuous intravenous infusion
Primary Outcome Measure Information:
Title
Percentage of Participants With a Minimal Residual Disease (MRD) Response Within the First Treatment Cycle
Description
At the end of the first treatment cycle (Day 29) a bone marrow aspiration/biopsy was performed and evaluated by the central MRD laboratory. Complete MRD response is defined as no polymerase chain reaction (PCR) amplification of individual rearrangements of immunoglobulin (Ig)- or T-cell receptor (TCR)-genes detected after completion of the first cycle.
Time Frame
During the first cycle (6 weeks)
Secondary Outcome Measure Information:
Title
Hematological Relapse-free Survival (RFS)
Description
Hematological RFS was measured from first dose of blinatumomab until the first assessment of documented relapse (either hematological or extramedullary), secondary leukemia, or death due to any cause. Participants without a documented relapse, or death due to any cause were censored at the time of their last hematological assessment. Participants who received chemotherapy for relapsed or persistent MRD or for any other reason after treatment with blinatumomab, or HSCT after treatment with blinatumomab, before hematological or extramedullary relapse, or death occurred were censored at the start of chemotherapy or HSCT, respectively. Hematological relapse was defined as unequivocal detection of > 5% leukemia cells in bone marrow as measured by cytological, microscopic assessment, presence of circulating leukemia blasts, or extramedullary leukemia (whichever occurred first). The 18-month Kaplan-Meier estimate of hematological RFS is reported.
Time Frame
18 months, up to the data cut-off date of 05 August 2015
Title
Overall Survival
Description
Overall survival was measured from the first treatment with blinatumomab until death due to any cause. Participants who did not die were censored at their last contact date.
Time Frame
Until the data cut-off date of 05 August 2015; median time on study was 18.3 months.
Title
100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplant
Description
The mortality rate within 100 days after allogeneic HSCT was defined as the Kaplan-Meier estimate of the percentage of participants dying within 100 days after the day of the first allogeneic HSCT.
Time Frame
100 days after HSCT, as of the data cut-off date of 05 August 2015
Title
Time to Hematological Relapse
Description
Time to hematological relapse was measured from the start of treatment with blinatumomab until hematological or extramedullary relapse. Participants who died or received HSCT or post-blinatumomab chemotherapy after treatment with blinatumomab were censored at their last hematological assessment prior to death or HSCT or post-blinatumomab chemotherapy (whichever occurred first).
Time Frame
Until the data cut-off date of 05 August 2015; median time on study was 18.3 months.
Title
Duration of Complete MRD Response
Description
The duration of MRD response was analyzed as the time from onset of MRD negativity until MRD or hematological relapse or date of last confirmation of negative MRD status. Participants who received chemotherapy or HSCT after treatment with blinatumomab, before hematological or extramedullary relapse were censored at the start of chemotherapy or HSCT, respectively. MRD relapse is defined as the reappearance of individual rearrangements of Ig- or TCR-genes ≥ lower limit of quantification (LLOQ) for at least 1 individual marker measured by an assay with a sensitivity of minimum 10^-4. Hematological relapse is defined as the unequivocal detection of > 5% leukemia cells in bone marrow as measured by cytological or microscopic assessment, presence of circulating leukemia blasts, or extramedullary leukemia.
Time Frame
Until the data cut-off date of 05 August 2015; median time on study was 18.3 months.
Title
Change in MRD Level From Baseline to End of Cycle 1 in Non-MRD Responders
Description
MRD level was measured by polymerase chain reaction (PCR) performed on bone marrow and assessed by the central laboratory. An MRD level of 10^-n corresponds to residual leukemia cells at a frequency of 1 per 10ⁿ bone marrow cells.
Time Frame
Baseline and end of cycle 1 (6 weeks)
Title
Number of Participants With Adverse Events
Description
Adverse events (AEs) were evaluated for severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4, as follows: Grade 1 - Mild AE; Grade 2 - Moderate AE; Grade 3 - Severe AE; Grade 4 - Life-threatening or disabling AE; Grade 5 - Death. The investigator used medical judgment to determine if there was a causal relationship (ie, related, unrelated) between an adverse event and blinatumomab. An AE was considered "serious" if it resulted in death, was life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant incapacity or substantial disruption to conduct normal life functions, was a congenital anomaly or birth defect or was a medically important condition.
Time Frame
From the first dose of blinatumomab until 30 days after last dose; the median treatment duration was 55 days.
Title
Change From Baseline in EORTC-QLQ-C30 Scales
Description
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Insomnia, Appetite Loss, Constipation, Diarrhea, Financial Impact). For each of these scales, scores range from 0 to 100. For the GHS and 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement. For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms. The maximum changes from baseline to cycles 1 through 4 and the change from baseline to the end of the core study are reported.
Time Frame
Baseline and the end of each treatment cycle (day 29 of each cycle) and 30 days after end of the last infusion (end of the core study, a maximum of 26 weeks).
Title
Change From Baseline in EuroQoL 5-Dimension (EQ-5D) Scales
Description
The EQ-5D is a self-administered questionnaire which captures 3 basic types of information: a descriptive profile (health state index) and the overall health rating using a visual analog scale. The health state index measures mobility, self-care, usual activities, pain/discomfort and anxiety/depression on scales from no problems (score = 1), some problems (score = 2), to extreme problems (score = 3). For each dimension the mean change from baseline was calculated at the end of each treatment cycle and at the end of the core study. The maximum observed change from baseline during cycles 1 to 4 and the change from baseline at the end of the core study are reported for each dimension.
Time Frame
Baseline and the end of each treatment cycle (day 29 of each cycle) and 30 days after end of the last infusion (end of the core study, a maximum of 26 weeks).
Title
Resource Utilization: Number of Participants Reporting Use of Transfusion of Blood Products
Time Frame
From first dose of study drug through the end of follow-up; median (minimum, maximum) time on study was 33.8 (1, 62) months
Title
Resource Utilization: Duration of Hospitalization
Time Frame
From first dose of study drug through the end of follow-up; median (minimum, maximum) time on study was 33.8 (1, 62) months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with B-precursor ALL in complete hematological remission after at least 3 intense chemotherapy blocks Presence of minimal residual disease at a level of ≥ 10^-3 Availability of bone marrow specimen from primary diagnosis for clone-specific MRD assessment Negative human immunodeficiency virus (HIV) test, negative hepatitis B (HbsAg) test and hepatitis C virus (anti-HCV) test Negative pregnancy test in women of childbearing potential Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Exclusion Criteria: Presence of circulating blasts or current extra-medullary involvement by ALL History of relevant central nervous system (CNS) pathology or current CNS pathology Prior allogeneic hematopoietic stem cell transplant (HSCT) Eligibility for treatment with tyrosine-kinase inhibitors (TKI) Systemic cancer chemotherapy within 2 weeks prior to study treatment Therapy with monoclonal antibodies (rituximab, alemtuzumab) within 4 weeks prior to study treatment Previous treatment with blinatumomab
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralf Bargou, MD
Organizational Affiliation
Medizinische Klinik und Poliklinik II, Würzburg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nicola Gökbuget, MD
Organizational Affiliation
Klinikum der Goethe Universität Frankfurt
Official's Role
Principal Investigator
Facility Information:
Facility Name
1102 - LKH Graz
City
Graz
Country
Austria
Facility Name
1107 - Krankenhaus der Elisabethinen
City
Linz
Country
Austria
Facility Name
1106
City
Salzburg
Country
Austria
Facility Name
1101 - AKH Wien
City
Vienna
Country
Austria
Facility Name
1504
City
Antwerpen
Country
Belgium
Facility Name
1502 - Cliniques Universitaires de Saint-Luc
City
Brussels
Country
Belgium
Facility Name
1505
City
Brügge
Country
Belgium
Facility Name
1503
City
Gent
Country
Belgium
Facility Name
1501 - Cliniques Universitaires UCL de Mont Godinne
City
Yvoir
Country
Belgium
Facility Name
1211 - CHU d'Angers
City
Angers
Country
France
Facility Name
1210 - CHU de Besançon
City
Besançon
Country
France
Facility Name
1206 - Hôpital de Pontoise
City
Cergy Pontoise
Country
France
Facility Name
1205 - CHU Henri Mondor
City
Créteil
Country
France
Facility Name
1209 - CHU de Lyon
City
Lyon
Country
France
Facility Name
1212 - Hôpital de l'hôtel Dieu
City
Nantes
Country
France
Facility Name
1213 - Centre Hospitalier Universitaire de Nice
City
Nice
Country
France
Facility Name
1201 - Hôpital Saint Louis
City
Paris
Country
France
Facility Name
1202 - CHU de Bordeaux - Hôpital Haut Lévêque
City
Pessac
Country
France
Facility Name
1208 - CHU de Purpan
City
Toulouse
Country
France
Facility Name
1011 - Charité Berlin
City
Berlin
Country
Germany
Facility Name
1022 - Universitätsklinkum Carl Gustav Carus Dresden
City
Dresden
Country
Germany
Facility Name
1009 - Universitätsklinikum Essen
City
Essen
Country
Germany
Facility Name
1002 - Klinikum der Goethe Universität
City
Frankfurt
Country
Germany
Facility Name
1014 - Asklepiosklinik St. Georg
City
Hamburg
Country
Germany
Facility Name
1018 - Medizinische Hochschule Hannover
City
Hannover
Country
Germany
Facility Name
1012 - Universitätsklinikum Heidelberg
City
Heidelberg
Country
Germany
Facility Name
1003 - Universitätsklinikum Schleswig-Holstein
City
Kiel
Country
Germany
Facility Name
1019 - Universitätsklinikum Leipzig
City
Leipzig
Country
Germany
Facility Name
1010 - Klinikum der Universität München - Großhadern
City
Munich
Country
Germany
Facility Name
1004 - Universitätsklinikum Münster
City
Münster
Country
Germany
Facility Name
1016 - Universitätsklinikum Regensburg
City
Regensburg
Country
Germany
Facility Name
1020 - Universitätsklinikum Rostock
City
Rostock
Country
Germany
Facility Name
1007 - Robert-Bosch-Krankenhaus
City
Stuttgart
Country
Germany
Facility Name
1015 - Universitätsklinikum Tübingen
City
Tübingen
Country
Germany
Facility Name
1005 - Universitätsklinikum Ulm
City
Ulm
Country
Germany
Facility Name
1001 - Julius-Maximilians-Universität Würzburg
City
Würzburg
Country
Germany
Facility Name
1301 - Ospedali Riuniti di Bergamo
City
Bergamo
Country
Italy
Facility Name
1303 - Istituto di Ematologia "L.& A.Seràgnoli" Azienda
City
Bologna
Country
Italy
Facility Name
1314 - Azienda Ospedaliera Spedali Civili Brescia
City
Brescia
Country
Italy
Facility Name
1313 - Universita di Catania
City
Catania
Country
Italy
Facility Name
1312 - Azienda Ospedaliera Universitaria San Martino
City
Genoa
Country
Italy
Facility Name
1305 - Ospedale San Gerardo
City
Monza
Country
Italy
Facility Name
1309 - Azienda Ospedaliera Antonio Cardarelli
City
Napoli
Country
Italy
Facility Name
1308 - Ospedali Riuniti "Villa Sofia-Cervello"
City
Palermo
Country
Italy
Facility Name
1302 - Università La Sapienza di Roma
City
Rome
Country
Italy
Facility Name
1310 - Fondazione Policlinico Tor Vergata
City
Rome
Country
Italy
Facility Name
1315 - Azienda Ospedaliero-Universitaria S. Giovanni Battista (Le Molinette)
City
Torino
Country
Italy
Facility Name
1311 - Azienda Ospedaliera di Verona
City
Verona
Country
Italy
Facility Name
2204 - UMC Groningen
City
Groningen
Country
Netherlands
Facility Name
2201 - Daniel Den Hoed Hospitaal
City
Rotterdam
Country
Netherlands
Facility Name
1905 - Uniwersytecki Szpital Kliniczny w Białymstoku
City
Bialystok
Country
Poland
Facility Name
1907 - Uniwersyteckie Centrum Kliniczne
City
Gdansk
Country
Poland
Facility Name
1908 - Swietokrzyskie Centrum Onkologii
City
Kielce
Country
Poland
Facility Name
1902 - Uniwersytet Medyczny w Lublinie
City
Lublin
Country
Poland
Facility Name
1901 - Klinika Hematologii - Instytut Hematologii i Transfuzjologii
City
Warsaw
Country
Poland
Facility Name
1906 - MTZ Clinical Research Sp. z o.o.
City
Warsaw
Country
Poland
Facility Name
1904 - Samodzielny Publiczny
City
Wrocław
Country
Poland
Facility Name
2101 - Institutul Clinic Fundeni, Hematologie II
City
Bucharest
Country
Romania
Facility Name
2102 - Spitalul Clinic Coltea, Hematologie
City
Bucharest
Country
Romania
Facility Name
2106 - Institutul Oncologic "Prof. Dr. I. Chiricuta"
City
Cluj-Napoca
Country
Romania
Facility Name
2105 - Institutul Regional de Oncologie
City
Iasi
Country
Romania
Facility Name
2001 - Russian Hematology Research Center
City
Moscow
Country
Russian Federation
Facility Name
2003 - Municipal Hospital No. 15
City
St. Petersburg
Country
Russian Federation
Facility Name
1401 - ICO Hospital Germans Trias I Pujol
City
Badalona
Country
Spain
Facility Name
1404 - Hospital Clínic Servei d´Hematologia
City
Barcelona
Country
Spain
Facility Name
1402 - Complexo Hospitalario Universitario A Coruña
City
La Coruña
Country
Spain
Facility Name
1408 - Hospital 12 de Octubre
City
Madrid
Country
Spain
Facility Name
1405 - Hospital Universitari Son Espases
City
Mallorca
Country
Spain
Facility Name
1407 - Unidad de Citogenética Oncológica
City
Salamanca
Country
Spain
Facility Name
1406 - Hospital Universitari i Politècnic La Fe de Valencia
City
Valencia
Country
Spain
Facility Name
1605 - Queen Elizabeth Hospital
City
Birmingham
Country
United Kingdom
Facility Name
1602 - Bristol Royal Infirmary
City
Bristol
Country
United Kingdom
Facility Name
1604 - University Hospital of Wales
City
Cardiff
Country
United Kingdom
Facility Name
1601 - Royal Free Hospital
City
London
Country
United Kingdom
Facility Name
1607 - Nottingham City Hospital NHS Trust
City
Nottingham
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
32619115
Citation
Gokbuget N, Zugmaier G, Dombret H, Stein A, Bonifacio M, Graux C, Faul C, Bruggemann M, Taylor K, Mergen N, Reichle A, Horst HA, Havelange V, Topp MS, Bargou RC. Curative outcomes following blinatumomab in adults with minimal residual disease B-cell precursor acute lymphoblastic leukemia. Leuk Lymphoma. 2020 Nov;61(11):2665-2673. doi: 10.1080/10428194.2020.1780583. Epub 2020 Jul 3.
Results Reference
derived
PubMed Identifier
30254079
Citation
Jen EY, Xu Q, Schetter A, Przepiorka D, Shen YL, Roscoe D, Sridhara R, Deisseroth A, Philip R, Farrell AT, Pazdur R. FDA Approval: Blinatumomab for Patients with B-cell Precursor Acute Lymphoblastic Leukemia in Morphologic Remission with Minimal Residual Disease. Clin Cancer Res. 2019 Jan 15;25(2):473-477. doi: 10.1158/1078-0432.CCR-18-2337. Epub 2018 Sep 25.
Results Reference
derived
PubMed Identifier
29358182
Citation
Gokbuget N, Dombret H, Bonifacio M, Reichle A, Graux C, Faul C, Diedrich H, Topp MS, Bruggemann M, Horst HA, Havelange V, Stieglmaier J, Wessels H, Haddad V, Benjamin JE, Zugmaier G, Nagorsen D, Bargou RC. Blinatumomab for minimal residual disease in adults with B-cell precursor acute lymphoblastic leukemia. Blood. 2018 Apr 5;131(14):1522-1531. doi: 10.1182/blood-2017-08-798322. Epub 2018 Jan 22. Erratum In: Blood. 2019 Jun 13;133(24):2625.
Results Reference
derived
PubMed Identifier
27209293
Citation
Zhu M, Wu B, Brandl C, Johnson J, Wolf A, Chow A, Doshi S. Blinatumomab, a Bispecific T-cell Engager (BiTE((R))) for CD-19 Targeted Cancer Immunotherapy: Clinical Pharmacology and Its Implications. Clin Pharmacokinet. 2016 Oct;55(10):1271-1288. doi: 10.1007/s40262-016-0405-4.
Results Reference
derived

Learn more about this trial

Confirmatory Phase II Study of Blinatumomab (MT103) in Patients With Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia (ALL)

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