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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-006520-19 | EudraCT Number |
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The purpose of this study is to determine whether the bispecific T-cell engager (BiTE®) Blinatumomab (MT103) is effective in the treatment of ALL patients with minimal residual disease.
The presence of leukemia cells below the cytological detection limit (5% leukemic cells) is defined as minimal residual disease (MRD). If no MRD is detectable (< 10^-4 = less than 1 leukemia cell per 10^4 bone marrow cells) a complete molecular remission is reached. In the last years a series of retrospective studies has shown that MRD in adult ALL is an independent prognostic factor as already demonstrated for childhood leukemia. Diagnostic tools for MRD are polymerase chain reaction (PCR) and/or flow cytometry. PCR analysis can detect fusion transcripts such as bcr/abl and individual clonal rearrangements of immunoglobulins (IgH) and/or T-cell receptor genes (TCR). About 25% of patients with MRD defined by rearrangement comprise a high-risk group with a 94% relapse rate within 3 years. In general for patients with MRD, who are not eligible for allogenic stem cell transplantation, curative treatment is not available. This accounts for MRD defined by the Philadelphia chromosome translocation as well as for MRD defined by rearrangement. The current study is set up to address the question of treating MRD positive ALL with the bispecific anti-cluster of differentiation (CD)19 x anti-CD3 antibody derivative blinatumomab (MT103).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blinatumomab | Experimental | Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m^2/day. A dose increase to 30 μg/m^2/day was permitted with evidence for insufficient response to blinatumomab treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blinatumomab (MT103) | Biological | Administered by continuous intravenous (CIV) over 4 weeks per cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Minimal Residual Disease (MRD) Response Within 4 Cycles of Treatment | MRD Response is defined as:
| Within 4 treatment cycles, 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an MRD Response After Each Treatment Cycle | MRD Response is defined as:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ralf Bargou, Professor | Julius-Maximilians-Universität Würzburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Ulm | Ulm | Baden-Wurttemberg | 89081 | Germany | ||
| Julius-Maximilians-Universität Würzburg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27209293 | Derived | 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. | |
| 25192414 | Derived | Zugmaier G, Topp MS, Alekar S, Viardot A, Horst HA, Neumann S, Stelljes M, Bargou RC, Goebeler M, Wessiepe D, Degenhard E, Gokbuget N, Klinger M. Long-term follow-up of serum immunoglobulin levels in blinatumomab-treated patients with minimal residual disease-positive B-precursor acute lymphoblastic leukemia. Blood Cancer J. 2014 Sep 5;4(9):244. doi: 10.1038/bcj.2014.64. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Blinatumomab | Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| At the end of each treatment cycle - Weeks 4, 10, 16, and 22. |
| Time to Hematological Relapse | The time to hematological relapse is defined as the time between start of first infusion of blinatumomab and the first result of hematological relapse. Participants without an event of hematological relapse were censored on their last available date of bone marrow aspiration/biopsy. Hematological relapse is defined as > 5% leukemia cells in bone marrow. Time to hematological relapse was analyzed using Kaplan-Meier methods. | Up to the data cut-off date of 14 January 2010; maximum duration of follow-up was 564 days. |
| Time to MRD Progression | Time to MRD progression is defined for participants who do not show MRD response at any time during the study as the time from start of first infusion until the first result of MRD progression or hematological relapse, if no MRD progression was diagnosed before hematological relapse. For participants who showed MRD response during the study the time to MRD progression is defined as the time from the date of the first MRD response to the date of MRD relapse. Participants without an event of MRD progression were censored on the day of their last bone marrow aspiration/biopsy. Participants who received a bone marrow transplant were censored on the last day of bone marrow aspiration/biopsy before transplantation. MRD progression is defined as the increase in the MRD level by 1 log as compared to the baseline level (equal to a 10-fold increase in the number of MRD cells), and had to be confirmed within 6 weeks. | Up to the data cut-off date of 14 January 2010; Median follow-up time was 155 days |
| Time to MRD Relapse | Time to MRD relapse is defined only for participants with an MRD response during the study, defined as the time between the date of the first MRD response and the date of MRD relapse. If a participant experienced hematological relapse without having shown MRD positivity before then the time point of MRD relapse is defined as the time point of hematological relapse. Participants without an event of MRD relapse or hematological relapse were censored on the day of their last available bone marrow aspiration/biopsy. If a participant received a bone marrow transplant the last day of bone marrow aspiration/biopsy before transplantation was used as time point for censoring. MRD relapse is defined as reappearance of bcr/abl, and/or t(4;11) translocation at any detection level, and/or by individual rearrangements of immunoglobulin or T-cell receptor genes ≥10^-4 for at least 1 individual marker measured by an assay with a sensitivity of minimum 10^-4 and should be confirmed within 6 weeks. | Up to the data cut-off date of 14 January 2010; Median follow-up time was 116.5 days |
| Number of Participants With Adverse Events | The severity (or intensity) of AEs was evaluated according to the grading scale provided in the Cancer Therapy Evaluation Program, Common Terminology Criteria for Adverse Events (CTCAE), version 3.0, or according to the following: 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. A serious adverse event (SAE) is any untoward medical occurrence or effect that, at any dose results in death, is life-threatening, requires or prolongs hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect. In addition, all laboratory abnormalities of grade four severity that occur during or after administration of the investigational drug, any overdose and a pregnancy or fathering were reported as SAEs. | From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days. |
| Change From Screening Value in B-cell Count During Cycle 1 | B-cells were measured by flow cytometry. | At Screening and in Cycle 1 at the start of infusion, 45 minutes, 2, 6, 12, 24 hours and at Days 2, 7, 14, 21, 28 and 35 after the start of infusion. |
| Change From Screening Value in T-cell Count During Cycle 1 | T-cells were measured by flow cytometry. | At Screening and in Cycle 1 at the start of infusion, 45 minutes, 2, 6, 12, 24 hours and at Days 2, 7, 14, 21, 28 and 35 after the start of infusion. |
| Serum Cytokine Peak Levels in Cycle 1 | The activation of immune effector cells was monitored by the measurement of peripheral blood cytokine levels including interleukin (IL)-2, IL-4, IL-6, IL-8, IL-10, tumor necrosis factor (TNF)-α and interferon gamma (IFN)-γ using fluorescence-activated cell sorter (FACS)-based cytometric bead array (CBA) system.The limit of detection (LOD) for the cytokine determination was 20 pg/mL, the limit of quantification (LOQ) was 125 pg/mL. | Cycle 1 at pre-dose and at post infusion start at 45 minutes; 2, 6, 12, 24, and 48 hours; 7, 14, 21, and 28 days. |
| Serum Blinatumomab Concentration at Steady State | The mean serum concentration of blinatumomab during cycle 1. The LOQ of the assay was 100 pg/mL, and the limit of detection (LOD) was 3 pg/mL. | Cycle 1 at predose and at 2, 6, and 12 hours after start of infusion then weekly until end of the cycle, and at 1, 2, 4, 6, 8, and 24 hours after stop of infusion. |
| Area Under the Drug Concentration-time Curve From Time Zero to Infinity | Cycle 1 at predose and at 2, 6, and 12 hours after start of infusion then weekly until end of the cycle, and at 1, 2, 4, 6, 8, and 24 hours after stop of infusion. |
| Apparent Volume of Distribution | Cycle 1 at predose and at 2, 6, and 12 hours after start of infusion then weekly until end of the cycle, and at 1, 2, 4, 6, 8, and 24 hours after stop of infusion. |
| Clearance of Blinatumomab | Cycle 1 at predose and at 2, 6, and 12 hours after start of infusion then weekly until end of the cycle, and at 1, 2, 4, 6, 8, and 24 hours after stop of infusion. |
| Terminal Half-life of Blinatumomab | Cycle 1 at predose and at 2, 6, and 12 hours after start of infusion then weekly until end of the cycle, and at 1, 2, 4, 6, 8, and 24 hours after stop of infusion. |
| Würzburg |
| Bavaria |
| 97080 |
| Germany |
| Klinikum der J.W. Goethe Universität | Frankfurt am Main | Hesse | 60590 | Germany |
| Universitätsklinikum Münster | Münster | North Rhine-Westphalia | 48129 | Germany |
| Universitätsklinikum Carl Gustav Carus | Dresden | Saxony | ´01307 | Germany |
| Universitätsklinikum Schleswig-Holstein im Städtischen Krankenhaus Kiel | Kiel | Schleswig-Holstein | 24116 | Germany |
| 22592608 | Derived | Klinger M, Brandl C, Zugmaier G, Hijazi Y, Bargou RC, Topp MS, Gokbuget N, Neumann S, Goebeler M, Viardot A, Stelljes M, Bruggemann M, Hoelzer D, Degenhard E, Nagorsen D, Baeuerle PA, Wolf A, Kufer P. Immunopharmacologic response of patients with B-lineage acute lymphoblastic leukemia to continuous infusion of T cell-engaging CD19/CD3-bispecific BiTE antibody blinatumomab. Blood. 2012 Jun 28;119(26):6226-33. doi: 10.1182/blood-2012-01-400515. Epub 2012 May 16. |
| Completed 1 Treatment Cycle |
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| COMPLETED |
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| NOT COMPLETED |
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|
Full Analysis Set included all participants who received ≥ 1 infusion of blinatumomab who completed at least the first treatment cycle and for whom at least one minimal residual disease (MRD) response assessment was available.
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| ID | Title | Description |
|---|---|---|
| BG000 | Blinatumomab | Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Genetic Alterations | bcr/abl: breakpoint cluster region; Ig: immunoglobulin; TCR: T-cell receptor. For bcr/abl above detection limit and t(4;11) translocation above detection limit participants may have rearrangements in addition to translocations. For Rearrangements of immunoglobulin / TCR genes participants did not show any translocation. | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With a Minimal Residual Disease (MRD) Response Within 4 Cycles of Treatment | MRD Response is defined as:
| Full analysis set | Posted | Number | 95% Confidence Interval | percentage of participants | Within 4 treatment cycles, 24 weeks |
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| Secondary | Percentage of Participants With an MRD Response After Each Treatment Cycle | MRD Response is defined as:
| Full analysis set | Posted | Number | 95% Confidence Interval | percentage of participants | At the end of each treatment cycle - Weeks 4, 10, 16, and 22. |
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| Secondary | Time to Hematological Relapse | The time to hematological relapse is defined as the time between start of first infusion of blinatumomab and the first result of hematological relapse. Participants without an event of hematological relapse were censored on their last available date of bone marrow aspiration/biopsy. Hematological relapse is defined as > 5% leukemia cells in bone marrow. Time to hematological relapse was analyzed using Kaplan-Meier methods. | Full analysis set | Posted | Median | 95% Confidence Interval | days | Up to the data cut-off date of 14 January 2010; maximum duration of follow-up was 564 days. |
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| Secondary | Time to MRD Progression | Time to MRD progression is defined for participants who do not show MRD response at any time during the study as the time from start of first infusion until the first result of MRD progression or hematological relapse, if no MRD progression was diagnosed before hematological relapse. For participants who showed MRD response during the study the time to MRD progression is defined as the time from the date of the first MRD response to the date of MRD relapse. Participants without an event of MRD progression were censored on the day of their last bone marrow aspiration/biopsy. Participants who received a bone marrow transplant were censored on the last day of bone marrow aspiration/biopsy before transplantation. MRD progression is defined as the increase in the MRD level by 1 log as compared to the baseline level (equal to a 10-fold increase in the number of MRD cells), and had to be confirmed within 6 weeks. | Full analysis set | Posted | Median | 95% Confidence Interval | days | Up to the data cut-off date of 14 January 2010; Median follow-up time was 155 days |
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| Secondary | Time to MRD Relapse | Time to MRD relapse is defined only for participants with an MRD response during the study, defined as the time between the date of the first MRD response and the date of MRD relapse. If a participant experienced hematological relapse without having shown MRD positivity before then the time point of MRD relapse is defined as the time point of hematological relapse. Participants without an event of MRD relapse or hematological relapse were censored on the day of their last available bone marrow aspiration/biopsy. If a participant received a bone marrow transplant the last day of bone marrow aspiration/biopsy before transplantation was used as time point for censoring. MRD relapse is defined as reappearance of bcr/abl, and/or t(4;11) translocation at any detection level, and/or by individual rearrangements of immunoglobulin or T-cell receptor genes ≥10^-4 for at least 1 individual marker measured by an assay with a sensitivity of minimum 10^-4 and should be confirmed within 6 weeks. | Full analysis set | Posted | Median | 95% Confidence Interval | days | Up to the data cut-off date of 14 January 2010; Median follow-up time was 116.5 days |
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| Secondary | Number of Participants With Adverse Events | The severity (or intensity) of AEs was evaluated according to the grading scale provided in the Cancer Therapy Evaluation Program, Common Terminology Criteria for Adverse Events (CTCAE), version 3.0, or according to the following: 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. A serious adverse event (SAE) is any untoward medical occurrence or effect that, at any dose results in death, is life-threatening, requires or prolongs hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect. In addition, all laboratory abnormalities of grade four severity that occur during or after administration of the investigational drug, any overdose and a pregnancy or fathering were reported as SAEs. | Safety analysis set, including all participants who received ≥ 1 infusion of blinatumomab. | Posted | Number | participants | From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days. |
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| Secondary | Change From Screening Value in B-cell Count During Cycle 1 | B-cells were measured by flow cytometry. | Participants who received blinatumomab with available pharmacodynamic data. | Posted | Mean | Standard Deviation | cells/μL | At Screening and in Cycle 1 at the start of infusion, 45 minutes, 2, 6, 12, 24 hours and at Days 2, 7, 14, 21, 28 and 35 after the start of infusion. |
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| Secondary | Change From Screening Value in T-cell Count During Cycle 1 | T-cells were measured by flow cytometry. | Participants who received blinatumomab with available pharmacodynamic data. | Posted | Mean | Standard Deviation | cells/μL | At Screening and in Cycle 1 at the start of infusion, 45 minutes, 2, 6, 12, 24 hours and at Days 2, 7, 14, 21, 28 and 35 after the start of infusion. |
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| Secondary | Serum Cytokine Peak Levels in Cycle 1 | The activation of immune effector cells was monitored by the measurement of peripheral blood cytokine levels including interleukin (IL)-2, IL-4, IL-6, IL-8, IL-10, tumor necrosis factor (TNF)-α and interferon gamma (IFN)-γ using fluorescence-activated cell sorter (FACS)-based cytometric bead array (CBA) system.The limit of detection (LOD) for the cytokine determination was 20 pg/mL, the limit of quantification (LOQ) was 125 pg/mL. | Safety analysis set | Posted | Mean | Standard Deviation | pg/mL | Cycle 1 at pre-dose and at post infusion start at 45 minutes; 2, 6, 12, 24, and 48 hours; 7, 14, 21, and 28 days. |
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| Secondary | Serum Blinatumomab Concentration at Steady State | The mean serum concentration of blinatumomab during cycle 1. The LOQ of the assay was 100 pg/mL, and the limit of detection (LOD) was 3 pg/mL. | Participants who received at least 1 infusion of blinatumomab with available pharmacokinetic data. | Posted | Mean | Standard Deviation | pg/mL | Cycle 1 at predose and at 2, 6, and 12 hours after start of infusion then weekly until end of the cycle, and at 1, 2, 4, 6, 8, and 24 hours after stop of infusion. |
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| Secondary | Area Under the Drug Concentration-time Curve From Time Zero to Infinity | Participants who received at least 1 infusion of blinatumomab with available pharmacokinetic data. | Posted | Mean | Standard Deviation | hr*ng/mL | Cycle 1 at predose and at 2, 6, and 12 hours after start of infusion then weekly until end of the cycle, and at 1, 2, 4, 6, 8, and 24 hours after stop of infusion. |
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| Secondary | Apparent Volume of Distribution | Participants who received at least 1 infusion of blinatumomab with available pharmacokinetic data. | Posted | Mean | Standard Deviation | L/m² | Cycle 1 at predose and at 2, 6, and 12 hours after start of infusion then weekly until end of the cycle, and at 1, 2, 4, 6, 8, and 24 hours after stop of infusion. |
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| Secondary | Clearance of Blinatumomab | Participants who received at least 1 infusion of blinatumomab with available pharmacokinetic data. | Posted | Mean | Standard Deviation | L/hr/m² | Cycle 1 at predose and at 2, 6, and 12 hours after start of infusion then weekly until end of the cycle, and at 1, 2, 4, 6, 8, and 24 hours after stop of infusion. |
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| Secondary | Terminal Half-life of Blinatumomab | Participants who received at least 1 infusion of blinatumomab with available pharmacokinetic data. | Posted | Mean | Standard Deviation | hours | Cycle 1 at predose and at 2, 6, and 12 hours after start of infusion then weekly until end of the cycle, and at 1, 2, 4, 6, 8, and 24 hours after stop of infusion. |
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From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Blinatumomab | Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment. | 10 | 21 | 21 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Catheter related infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Medical device complication | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Thrombosis in device | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
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| Lacrimation increased | Eye disorders | MedDRA 11.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Catheter site erythema | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Catheter site pain | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Chills | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Immunodeficiency | Immune system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Blood immunoglobulin A decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
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| Blood immunoglobulin G decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
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| Blood immunoglobulin M decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
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| Blood lactate dehydrogenase increased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 11.0 | Systematic Assessment |
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| Coagulation factor XIII level increased | Investigations | MedDRA 11.0 | Systematic Assessment |
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| Fibrin D dimer increased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 11.0 | Systematic Assessment |
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| Immunoglobulins decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
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| Monocyte count increased | Investigations | MedDRA 11.0 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA 11.0 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Growing pains | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Periorbital oedema | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D018365 | Neoplasm, Residual |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C510808 | blinatumomab |
| C568788 | N,N-dicyclohexyl-isoborneol-10-sulfonamide |
Not provided
Not provided
Not provided
| 41-50 years |
|
| 51-60 years |
|
| 61-70 years |
|
| > 70 years |
|
|
| Rearrangements of Ig / TCR genes only |
|
| Rearrangements of Ig / TCR genes & translocations |
|
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