Relapsed/Refractory Philadelphia Positive B-precursor ALL
Conditions
Keywords
Relapsed; Refractory; Philadelphia Positive; B-precursor; Acute Lymphoblastic Leukemia; ALL; Blinatumomab; Leukemia;
Brief summary
The primary objective is to evaluate the rate of complete remission/complete remission with partial hematological recovery (CRh\*) in adults with relapsed/refractory Philadelphia chromosome positive (Ph+) B-precursor acute lymphoblastic leukemia (ALL) who receive blinatumomab.
Detailed description
This is a single-arm Simon II stage design, multicenter study consisting of a screening period, an induction treatment period (2 cycles of blinatumomab), a consolidation treatment period (up to 3 additional cycles of blinatumomab for applicable participants), and a safety follow-up visit 30 days after treatment. Following the safety follow-up visit, participants will be followed for response duration and survival every 3 months for 18 months or death, whichever occurs first.
Interventions
DRUGBlinatumomab
Blinatumomab is administered as a continuous intravenous infusion (CIV). A single cycle of blinatumomab treatment is 6 weeks in duration, which includes 4 weeks of blinatumomab followed by a 2-week treatment-free interval.
Sponsors
Amgen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with Ph+ B-precursor ALL, with any of the following: * Relapsed or refractory to at least one second generation tyrosine kinase inhibitor (TKI) (dasatinib, nilotinib, bosutinib, ponatinib) * OR intolerant to second generation TKI and intolerant or refractory to imatinib mesylate * Greater than 5% blasts in bone marrow * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Age ≥ 18 years of age, at the time of informed consent. * Subject has provided informed consent or subject's legally acceptable representative has provided informed consent when the subject has any kind of condition that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent.
Exclusion criteria
* History of malignancy other than ALL within 5 years prior to start of protocol-required therapy, except for adequately treated selected cancers without evidence of disease * History or presence of clinically relevant central nervous system (CNS) pathology as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis * Active ALL in the CNS or testes * Isolated extramedullary disease * Current autoimmune disease or history of autoimmune disease with potential CNS involvement * Allogeneic hematopoietic stem cell transplantation (HSCT) within 12 weeks before blinatumomab treatment * Active acute or extensive chronic graft-versus-host disease (GvHD) which included the administration of immunosuppressive agents to prevent or treat GvHD within 2 weeks before blinatumomab treatment * immediately previous cancer chemotherapy, radiotherapy, or immunotherapy; and eligibility for allogeneic HSCT at the time of enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Complete Remission/Complete Remission With Partial Hematological Recovery (CR/CRh*) During the First Two Treatment Cycles | Approximately 12 weeks, as of the data cut-off date of 20 May 2015 | Participants were evaluated for efficacy at the end of each treatment cycle via a central bone marrow aspiration and local peripheral blood counts. Complete remission was defined as meeting all 3 of the following criteria: * less than or equal to 5% blasts in the bone marrow; * no evidence of disease * full recovery of peripheral blood counts: platelets \> 100,000/μl, and absolute neutrophil count (ANC) \> 1000/μl. Complete remission with partial hematological recovery (CRh\*) was defined as meeting all 3 of the following criteria: * less than or equal to 5% blasts in the bone marrow * no evidence of disease * partial recovery of peripheral blood counts: platelets \> 50,000/μl, and ANC \> 500/μl. Participants without a post-baseline disease assessment were considered non-responders. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of CR or CRh* Response | Up to the data cut-off date of 20 May 2015; median observation time was 7.0 months | Duration of response was measured for participants in remission (CR/CRh\*), and was measured from the time the participant first achieved remission until first documented relapse or death from disease progression. Participants without a documented relapse (hematological or extramedullary) and who did not die were censored at the time of the last bone marrow assessment or the last survival follow-up visit to confirm remission. Participants who died without having reported hematological relapse or without showing any clinical sign of disease progression were censored on their date of death. |
| Percentage of Participants With Complete Remission (CR) During the First Two Treatment Cycles | Approximately 12 weeks, as of the data cut-off date of 20 May 2015 | Participants were evaluated for efficacy at the end of each treatment cycle via a central bone marrow aspiration and local peripheral blood counts. Complete remission was defined as meeting all 3 of the following criteria: * less than or equal to 5% blasts in the bone marrow; * no evidence of disease; * full recovery of peripheral blood counts: platelets \> 100,000/μl, and absolute neutrophil count (ANC) \> 1000/μl. Participants without a post-baseline disease assessment were considered non-responders. |
| Percentage of Participants With Complete Remission With Partial Hematological Recovery (CRh*) During the First Two Treatment Cycles | Approximately 12 weeks, as of the data cut-off date of 20 May 2015 | Participants were evaluated for efficacy at the end of each treatment cycle via a central bone marrow aspiration and local peripheral blood counts. Complete remission with partial hematological recovery (CRh\*) was defined as meeting all 3 of the following criteria: * less than or equal to 5% blasts in the bone marrow; * no evidence of disease; * partial recovery of peripheral blood counts: platelets \> 50,000/μl, and ANC \> 500/μl. Participants without a post-baseline disease assessment were considered non-responders. |
| Percentage of Participants With Complete Remission/Complete Remission With Partial Hematological Recovery/Complete Remission With Incomplete Hematological Recovery (CR/CRh*/CRi) During the First Two Treatment Cycles | Approximately 12 weeks, as of the data cut-off date of 20 May 2015 | Efficacy was evaluated via a central bone marrow aspiration and local peripheral blood counts. Complete remission was defined as meeting the following criteria: * less than or equal to 5% blasts in the bone marrow; * no evidence of disease; * full recovery of peripheral blood counts: platelets \> 100,000/μl, and absolute neutrophil count (ANC) \> 1000/μl. Complete remission with partial hematological recovery was defined as meeting the following criteria: * less than or equal to 5% blasts in the bone marrow; * no evidence of disease; * partial recovery of peripheral blood counts: platelets \> 50,000/μl, and ANC \> 500/μl. Complete remission with incomplete hematologic recovery was defined as meeting all of the following criteria: * less than or equal to 5% blasts in the bone marrow; * no evidence of disease; * incomplete recovery of peripheral blood counts: platelets \> 100,000/μl or ANC \> 1000/μl. Participants without a post-baseline disease assessment were considered non-responders. |
| Overall Survival | From first dose of blinatumomab until the data cut-off date; median observation time was 8.8 months. | Overall survival was assessed from the date the participant received the first infusion of blinatumomab until death from any cause or the date of the last follow-up. Participants still alive at the data cut-off date were censored on the last documented visit date or the date of the last contact when the patient was last known to have been alive. |
| Percentage of Participants With Minimal Residual Disease (MRD) Remission During the First 2 Cycles of Treatment | Approximately 12 weeks | Bone marrow samples were evaluated for MRD remission by a central laboratory using bcr-abl fusion gene reverse transcription polymerase chain reaction (RT-PCR). An MRD response was defined as MRD \< 10\^-4 measured by PCR. Participants with no post-baseline MRD assessment were considered non-responders. |
| 100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplant | From the date of allogeneic HSCT until the data cut-off date of 20 May 2015; median observation time was 3.2 months. | The analysis of 100-day mortality after allogeneic HSCT was assessed for participants who received an allogeneic HSCT while in remission (CR/CRh\*) after 2 cycles of blinatumomab treatment and did not receive any additional antileukemic treatment. 100-day mortality after allogeneic HSCT was calculated relative to the date of allogeneic HSCT. The 100-day mortality rate after allogeneic HSCT was defined as the percentage of participants having died up to 100 days after allogeneic HSCT estimated using the estimated time to death in percent calculated by Kaplan-Meier methods. Participants alive were censored on the last documented visit date or the date of the last phone contact when the patient was last known to have been alive. |
| Number of Participants With Adverse Events | From the first dose of blinatumomab until 30 days after the last dose, up to the cut-off date of 20 May 2015; the median duration of treatment was 53.8 days. | Adverse events (AEs) were graded for severity according to the CTCAE version 4.0, where Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE. Treatment-related adverse events (TRAEs) were those assessed by the investigator as possibly related to blinatumomab based on response to the question: Is there a reasonable possibility that the event may have been caused by blinatumomab or other protocol-specified therapies/procedures? |
| Number of Participants Who Developed Anti-blinatumomab Antibodies | Day 29 of each treatment period and 30 days after the last dose | Anti-blinatumomab binding antibodies were evaluated with a validated blinatumomab anti-drug antibody assay with the electrochemiluminescence detection technology. |
| Steady State Concentration of Blinatumomab | Cycle 1, day 8, 6 to 8 hours after the dose step to 28 μg/day, and Cycle 2, day 1, 6 to 8 hours after blinatumomab infusion | — |
| Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT) During Blinatumomab Induced Remission | Up to the data cut-of date of 20 May 2015; Maximum duration on study was 14.5 months. | Participants who achieved remission (CR/CRh\*) during the first 2 cycles of treatment and received an allogeneic HSCT. |
Countries
France, Germany, Italy, United Kingdom, United States
Participant flow
Recruitment details
This study was conducted at 19 centers in 4 European countries and the United States: 3 centers in France, 3 in Germany, 5 in Italy, 1 in the United Kingdom, and 7 in the United States. The first participant enrolled on 03 January 2014 and the last participant enrolled on 12 January 2015.
Pre-assignment details
Results are reported as of the data cut-off date of 20 May 2015.
Participants by arm
| Arm | Count |
|---|---|
| Blinatumomab Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.
The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment. | 45 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 22 |
Baseline characteristics
| Characteristic | Blinatumomab |
|---|---|
| Age, Continuous | 52.8 years STANDARD_DEVIATION 15 |
| Age, Customized 18 to < 35 years | 5 participants |
| Age, Customized 35 to < 55 years | 17 participants |
| Age, Customized 55 to < 65 years | 11 participants |
| Age, Customized ≥ 65 years | 12 participants |
| Number of Prior Relapses 1 relapse | 25 participants |
| Number of Prior Relapses 2 relapses | 13 participants |
| Number of Prior Relapses ≥ 3 relapses | 4 participants |
| Number of Prior Relapses No relapses | 3 participants |
| Number of Prior Salvage Regimens 0 regimens | 14 participants |
| Number of Prior Salvage Regimens 1 regimen | 12 participants |
| Number of Prior Salvage Regimens 2 regimens | 11 participants |
| Number of Prior Salvage Regimens ≥ 3 regimens | 8 participants |
| Prior Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) No | 25 participants |
| Prior Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) Yes | 20 participants |
| Prior Tyrosine Kinase Inhibitor (TKI) Treatment 1 TKI | 7 participants |
| Prior Tyrosine Kinase Inhibitor (TKI) Treatment 2 TKIs | 21 participants |
| Prior Tyrosine Kinase Inhibitor (TKI) Treatment 3 TKIs | 13 participants |
| Prior Tyrosine Kinase Inhibitor (TKI) Treatment 4 TKIs | 4 participants |
| Race/Ethnicity, Customized Asian | 1 participants |
| Race/Ethnicity, Customized Black (or African American) | 3 participants |
| Race/Ethnicity, Customized Hispanic/Latino | 2 participants |
| Race/Ethnicity, Customized Not Hispanic/Latino | 43 participants |
| Race/Ethnicity, Customized Other | 2 participants |
| Race/Ethnicity, Customized White | 39 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 24 Participants |
| Time From Initial Diagnosis | 27.3 months STANDARD_DEVIATION 26.1 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 45 / 45 |
| serious Total, serious adverse events | 28 / 45 |
Outcome results
Primary
Percentage of Participants With Complete Remission/Complete Remission With Partial Hematological Recovery (CR/CRh*) During the First Two Treatment Cycles
Participants were evaluated for efficacy at the end of each treatment cycle via a central bone marrow aspiration and local peripheral blood counts. Complete remission was defined as meeting all 3 of the following criteria: * less than or equal to 5% blasts in the bone marrow; * no evidence of disease * full recovery of peripheral blood counts: platelets \> 100,000/μl, and absolute neutrophil count (ANC) \> 1000/μl. Complete remission with partial hematological recovery (CRh\*) was defined as meeting all 3 of the following criteria: * less than or equal to 5% blasts in the bone marrow * no evidence of disease * partial recovery of peripheral blood counts: platelets \> 50,000/μl, and ANC \> 500/μl. Participants without a post-baseline disease assessment were considered non-responders.
Time frame: Approximately 12 weeks, as of the data cut-off date of 20 May 2015
Population: All participants who received an infusion of blinatumomab.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Blinatumomab | Percentage of Participants With Complete Remission/Complete Remission With Partial Hematological Recovery (CR/CRh*) During the First Two Treatment Cycles | 35.6 percentage of participants |
Secondary
100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplant
The analysis of 100-day mortality after allogeneic HSCT was assessed for participants who received an allogeneic HSCT while in remission (CR/CRh\*) after 2 cycles of blinatumomab treatment and did not receive any additional antileukemic treatment. 100-day mortality after allogeneic HSCT was calculated relative to the date of allogeneic HSCT. The 100-day mortality rate after allogeneic HSCT was defined as the percentage of participants having died up to 100 days after allogeneic HSCT estimated using the estimated time to death in percent calculated by Kaplan-Meier methods. Participants alive were censored on the last documented visit date or the date of the last phone contact when the patient was last known to have been alive.
Time frame: From the date of allogeneic HSCT until the data cut-off date of 20 May 2015; median observation time was 3.2 months.
Population: Participants who received allogeneic HSCT and were in remission with a CR/CRh\* after 2 cycles of treatment and received the transplant without receiving any additional antileukemic medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Blinatumomab | 100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplant | 25.0 percentage of participants |
Secondary
Duration of CR or CRh* Response
Duration of response was measured for participants in remission (CR/CRh\*), and was measured from the time the participant first achieved remission until first documented relapse or death from disease progression. Participants without a documented relapse (hematological or extramedullary) and who did not die were censored at the time of the last bone marrow assessment or the last survival follow-up visit to confirm remission. Participants who died without having reported hematological relapse or without showing any clinical sign of disease progression were censored on their date of death.
Time frame: Up to the data cut-off date of 20 May 2015; median observation time was 7.0 months
Population: Participants who received an infusion of blinatumomab and with a CR or CRh\* response during the first 2 treatment cycles.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Blinatumomab | Duration of CR or CRh* Response | 6.7 months |
Secondary
Number of Participants Who Developed Anti-blinatumomab Antibodies
Anti-blinatumomab binding antibodies were evaluated with a validated blinatumomab anti-drug antibody assay with the electrochemiluminescence detection technology.
Time frame: Day 29 of each treatment period and 30 days after the last dose
Population: Participants with available post-baseline antibody results
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Blinatumomab | Number of Participants Who Developed Anti-blinatumomab Antibodies | 0 participants |
Secondary
Number of Participants With Adverse Events
Adverse events (AEs) were graded for severity according to the CTCAE version 4.0, where Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE. Treatment-related adverse events (TRAEs) were those assessed by the investigator as possibly related to blinatumomab based on response to the question: Is there a reasonable possibility that the event may have been caused by blinatumomab or other protocol-specified therapies/procedures?
Time frame: From the first dose of blinatumomab until 30 days after the last dose, up to the cut-off date of 20 May 2015; the median duration of treatment was 53.8 days.
Population: All participants who received an infusion of blinatumomab
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Blinatumomab | Number of Participants With Adverse Events | Any adverse event | 45 participants |
| Blinatumomab | Number of Participants With Adverse Events | AE grade ≥ 3 | 37 participants |
| Blinatumomab | Number of Participants With Adverse Events | AE grade ≥ 4 | 18 participants |
| Blinatumomab | Number of Participants With Adverse Events | Serious adverse events | 28 participants |
| Blinatumomab | Number of Participants With Adverse Events | Leading to discontinuation of blinatumomab | 3 participants |
| Blinatumomab | Number of Participants With Adverse Events | Leading to interruption of blinatumomab | 16 participants |
| Blinatumomab | Number of Participants With Adverse Events | Fatal adverse events | 5 participants |
| Blinatumomab | Number of Participants With Adverse Events | Treatment-related adverse events | 41 participants |
| Blinatumomab | Number of Participants With Adverse Events | Treatment-related AE grade ≥ 3 | 20 participants |
| Blinatumomab | Number of Participants With Adverse Events | Treatment-related AE grade ≥ 4 | 7 participants |
| Blinatumomab | Number of Participants With Adverse Events | Treatment-related serious adverse events | 12 participants |
| Blinatumomab | Number of Participants With Adverse Events | TRAE leading to discontinuation of blinatumomab | 2 participants |
| Blinatumomab | Number of Participants With Adverse Events | TRAE leading to interruption of blinatumomab | 12 participants |
| Blinatumomab | Number of Participants With Adverse Events | Treatment-related fatal adverse events | 1 participants |
Secondary
Overall Survival
Overall survival was assessed from the date the participant received the first infusion of blinatumomab until death from any cause or the date of the last follow-up. Participants still alive at the data cut-off date were censored on the last documented visit date or the date of the last contact when the patient was last known to have been alive.
Time frame: From first dose of blinatumomab until the data cut-off date; median observation time was 8.8 months.
Population: All participants who received an infusion of blinatumomab
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Blinatumomab | Overall Survival | 7.1 months |
Secondary
Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT) During Blinatumomab Induced Remission
Participants who achieved remission (CR/CRh\*) during the first 2 cycles of treatment and received an allogeneic HSCT.
Time frame: Up to the data cut-of date of 20 May 2015; Maximum duration on study was 14.5 months.
Population: Participants who received an infusion of blinatumomab and had a CR/CRh\* response during the first 2 cycles of treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Blinatumomab | Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT) During Blinatumomab Induced Remission | 43.8 percentage of participants |
Secondary
Percentage of Participants With Complete Remission/Complete Remission With Partial Hematological Recovery/Complete Remission With Incomplete Hematological Recovery (CR/CRh*/CRi) During the First Two Treatment Cycles
Efficacy was evaluated via a central bone marrow aspiration and local peripheral blood counts. Complete remission was defined as meeting the following criteria: * less than or equal to 5% blasts in the bone marrow; * no evidence of disease; * full recovery of peripheral blood counts: platelets \> 100,000/μl, and absolute neutrophil count (ANC) \> 1000/μl. Complete remission with partial hematological recovery was defined as meeting the following criteria: * less than or equal to 5% blasts in the bone marrow; * no evidence of disease; * partial recovery of peripheral blood counts: platelets \> 50,000/μl, and ANC \> 500/μl. Complete remission with incomplete hematologic recovery was defined as meeting all of the following criteria: * less than or equal to 5% blasts in the bone marrow; * no evidence of disease; * incomplete recovery of peripheral blood counts: platelets \> 100,000/μl or ANC \> 1000/μl. Participants without a post-baseline disease assessment were considered non-responders.
Time frame: Approximately 12 weeks, as of the data cut-off date of 20 May 2015
Population: All participants who received an infusion of blinatumomab
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Blinatumomab | Percentage of Participants With Complete Remission/Complete Remission With Partial Hematological Recovery/Complete Remission With Incomplete Hematological Recovery (CR/CRh*/CRi) During the First Two Treatment Cycles | 40.0 percentage of participants |
Secondary
Percentage of Participants With Complete Remission (CR) During the First Two Treatment Cycles
Participants were evaluated for efficacy at the end of each treatment cycle via a central bone marrow aspiration and local peripheral blood counts. Complete remission was defined as meeting all 3 of the following criteria: * less than or equal to 5% blasts in the bone marrow; * no evidence of disease; * full recovery of peripheral blood counts: platelets \> 100,000/μl, and absolute neutrophil count (ANC) \> 1000/μl. Participants without a post-baseline disease assessment were considered non-responders.
Time frame: Approximately 12 weeks, as of the data cut-off date of 20 May 2015
Population: All participants who received an infusion of blinatumomab
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Blinatumomab | Percentage of Participants With Complete Remission (CR) During the First Two Treatment Cycles | 31.1 percentage of participants |
Secondary
Percentage of Participants With Complete Remission With Partial Hematological Recovery (CRh*) During the First Two Treatment Cycles
Participants were evaluated for efficacy at the end of each treatment cycle via a central bone marrow aspiration and local peripheral blood counts. Complete remission with partial hematological recovery (CRh\*) was defined as meeting all 3 of the following criteria: * less than or equal to 5% blasts in the bone marrow; * no evidence of disease; * partial recovery of peripheral blood counts: platelets \> 50,000/μl, and ANC \> 500/μl. Participants without a post-baseline disease assessment were considered non-responders.
Time frame: Approximately 12 weeks, as of the data cut-off date of 20 May 2015
Population: All participants who received an infusion of blinatumomab
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Blinatumomab | Percentage of Participants With Complete Remission With Partial Hematological Recovery (CRh*) During the First Two Treatment Cycles | 4.4 percentage of participants |
Secondary
Percentage of Participants With Minimal Residual Disease (MRD) Remission During the First 2 Cycles of Treatment
Bone marrow samples were evaluated for MRD remission by a central laboratory using bcr-abl fusion gene reverse transcription polymerase chain reaction (RT-PCR). An MRD response was defined as MRD \< 10\^-4 measured by PCR. Participants with no post-baseline MRD assessment were considered non-responders.
Time frame: Approximately 12 weeks
Population: All participants who received an infusion of blinatumomab.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Blinatumomab | Percentage of Participants With Minimal Residual Disease (MRD) Remission During the First 2 Cycles of Treatment | 40.0 percentage of participants |
Secondary
Steady State Concentration of Blinatumomab
Time frame: Cycle 1, day 8, 6 to 8 hours after the dose step to 28 μg/day, and Cycle 2, day 1, 6 to 8 hours after blinatumomab infusion
Population: Participants with available serum concentration data
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Blinatumomab | Steady State Concentration of Blinatumomab | Cycle 2 (n = 21) | 532 pg/mL | Geometric Coefficient of Variation 128.7 |
| Blinatumomab | Steady State Concentration of Blinatumomab | Cycle 1 | 449 pg/mL | Geometric Coefficient of Variation 125.6 |