A Phase 3 interventional study of Blinatumomab and Dexamthasone in Acute Lymphoblastic Leukemia, sponsored by Amgen. Completed at 23 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-08.
Sponsored by Amgen · Phase 3, Interventional, and Treatment
This study is being done to evaluate the rate of hematological response (complete remission/complete remission with partial hematological recovery [CR/CRh*]) induced by blinatumomab in Chinese adults with relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL).
This is an open label, single-arm, multicenter phase 3 study to evaluate efficacy and safety of the BiTE (bispecific T cell engager) antibody blinatumomab in Chinese adults with relapsed/refractory B-precursor ALL. The study will consist of a screening period, a treatment period, and a follow-up period.
Treatment will consist of up to 5 cycles of blinatumomab. Participants who achieve a bone marrow (BM) response (≤ 5% BM blasts) or CR/CRh*/CRi within 2 induction cycles of treatment may continue to receive up to 3 additional consolidation cycles of blinatumomab. Thirty days after end of the last dose of protocol-specified therapy, participants will have a safety follow-up visit.
If subjects are suitable for allogeneic stem cell transplantation (alloHSCT) after treatment with blinatumomab, they may undergo alloHSCT instead of receiving further consolidation cycles with blinatumomab.
Participants will be followed via clinic visit or telephone contact every 3 months after their safety follow-up visit until death has been observed or a maximum of 2 years after start of treatment, whichever occurs first.
A planned interim analysis to assess efficacy and safety of blinatumomab was to be based on the interim analysis set (N = 90). The efficacious benefit assessment based on an O'Brien-Fleming alpha spending function (O'Brien and Fleming, 1979) with the critical boundary 42.2% at the interim analysis and 39.2% at the primary analysis in CR/CRh* rate. If the interim analysis showed statistically efficacious and overall benefit-risk analysis to be promising per the data review team review, then the interim analysis could become the primary analysis of this study. In addition, the study would continue its enrollment until 120 participants had been enrolled and continued their participation in the study to complete protocol-specified procedures.
The data cutoff date of 12 April 2019 allowed for the 90th participant enrolled before 21 February 2019 to have had the opportunity to complete 2 cycles of treatment and the safety follow-up visit (if the participant had discontinued treatment after 2 cycles).
Exclusion Criteria:
Disease Related
Other Medical Conditions
Medications or Other Treatments
General
Treatment consisted of two induction cycles and up to 3 consolidation cycles of treatment for responders. In the first induction cycle, the initial dose of blinatumomab was 9 μg/day for Days 1-7 and then escalated (dose step) to 28 μg/day starting on day 8 (week 2) through day 29 (week 4). This is followed by two weeks without blinatumomab treatment. In subsequent cycles (beginning with the second induction cycle and continuing through consolidation, for applicable participants) 28 μg/day was administered for all 4 weeks of continuous treatment, followed by a treatment-free interval of two weeks.
Drug: Blinatumomab · Drug: Dexamthasone
Blinatumomab will be supplied as single-use glass injection vials as a sterile, preservative-free, white to off-white, lyophilized powder for reconstitution and administration by continuous intravenous infusion (CIVI). A single cycle of blinatumomab treatment is 6 weeks in duration, which includes 4 weeks of blinatumomab CIVI followed by a 2 week treatment-free interval. The treatment-free interval may be prolonged by up to 7 days, if deemed necessary by the investigator.
Also known as: BLINCYTO®, AMG 103, MT103
Premedication with dexamethasone was intended to prevent cytokine release syndrome (CRS) events associated with blinatumomab treatment. Treatment could start pre-study. Dexamethasone 20 mg IV was administered within 3 hours before start of blinatumomab in each treatment cycle, and within 3 hours before dose step increase.
Percentage of Participants With a Hematological Response of Complete Remission (CR) or Complete Remission With Partial Hematological Recovery (CRh*) During the First 2 Treatment Cycles With Blinatumomab
A CR is defined as having ≤ 5% blasts in the bone marrow, no evidence of disease, and full recovery of peripheral blood counts (platelets \> 100,000/μL, and absolute neutrophil count \[ANC\] \> 1,000/μL). CRh\* is defined as ≤ 5% blasts in the bone marrow, no evidence of disease and partial recovery of peripheral blood counts: platelets \> 50,000/μl, and ANC \> 500/μl. CR/CRh\* rate is defined as the percentage of participants who achieve CR/CRh\* within 2 cycles of treatment with blinatumomab. Participants without response assessment were accounted for in the denominator when calculating the response rate, ie, these participants were counted as non-responders. The interim analysis was to become the primary analysis by meeting pre-specified efficacy and safety criteria based on an O'Brien-Fleming alpha spending function with the critical boundary 42.2%. Results for both the interim and final analysis are reported.
Time frame: Within 2 cycles of treatment (12 weeks)
Percentage of Participants With a Hematological Response of Complete Remission (CR) During the First 2 Treatment Cycles With Blinatumomab
A CR is defined as having ≤ 5% blasts in the bone marrow, no evidence of disease, and full recovery of peripheral blood counts (platelets \> 100,000/μL, and absolute neutrophil count \[ANC\] \> 1,000/μL). CR rate is defined as the percentage of participants who achieved CR within 2 cycles of treatment with blinatumomab. Participants without response assessment were accounted for in the denominator when calculating the response rate, ie, these participants were counted as non-responders. Results for both the interim and final analysis are reported.
Time frame: Within 2 cycles of treatment (12 weeks)
Percentage of Participants With a CR or CRh* or Complete Remission With Incomplete Hematological Recovery Without CRh* (CRi) (CR/CRh*/CRi) During the First 2 Treatment Cycles With Blinatumomab
CRi is defined as ≤ 5% blasts in the bone marrow, no evidence of disease and incomplete recovery of peripheral blood counts: platelets \> 100,000/μl or ANC \> 1,000/μl (but not both). CR/CRh\*/CRi rate is defined as the percentage of participants who achieve CR/CRh\*/CRi within 2 cycles of treatment with blinatumomab. Participants without response assessment were accounted for in the denominator when calculating the response rate, ie, these participants were counted as non-responders. Results for both the interim and final analysis are reported.
Time frame: Within 2 cycles of treatment (12 weeks)
Pharmacokinetic (PK) Parameter: Concentration of Blinatumomab at Steady State (Css)
Blinatumomab serum concentration was quantified using a validated enzyme- linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 pg/mL. Blinatumomab serum steady-state concentrations (Css) was summarized as the average of the observed concentrations collected after 24 hours from the start of continuous IV infusion for each dose level. Cycle 1 day 2 values represent Css for the initial dose of blinatumomab (9 µg/day). Values collected from other time points were used to calculate Css of 28 µg/day dose in their respective cycles.
Time frame: Cycle 1: Days 2, 15, and 29; Cycle 2: Days 2, 15, and 29 (approximately study days 44, 57, and 71)
Pharmacokinetic (PK) Parameter: Clearance
Systemic clearance (CL) calculated as the average CL value during cycle 1 and cycle 2, where CL = infusion rate (μg/hour) / Css
Time frame: Cycle 1: Days 2, 15 and 29; Cycle 2: Days 2, 15 and 29 (approximately study days 44, 57 and 71)
Pharmacokinetic (PK) Parameter: Terminal Half-Life
Terminal half-life (t1/2,z) calculated as t1/2,z = ln(2)/lambda-z, where lambda-z was the first-order rate constant estimated via linear regression of the terminal log-linear decay phase from day 29 post-end of infusion collections.
Time frame: Cycle 1 Day 29: prior to end of infusion and after the end of infusion at 3 hours and 6 hours
Pharmacokinetic (PK) Parameter: Volume of Distribution
The volume of distribution (Vz) was calculated as Vz = CL/lambda-z, where lambda-z was the first-order rate constant estimated based on cycle 1 day 29 collections via linear regression of the terminal log-linear decay phase as determined from the noncompartmental analysis and where CL was the CL averaged over multiple cycles. Volume of distribution was estimated for participants who have sufficient evaluable PK data.
Time frame: Cycle 1: Days 2, 15 and 29; Cycle 2: Days 2, 15, and 29 (approximately study days 44, 57 and 71)
Kaplan-Meier Estimates for Overall Survival (OS)
Overall survival time was calculated from the time of first infusion of blinatumomab until death due to any cause. Participants still alive were censored at the date last known to be alive up until the data cut-off date (interim analysis) or end of study date (final analysis). Months are calculated as days from the first treatment to death/censor date, divided by 30.5. Results for both the interim and final analysis are reported.
Time frame: Interim analysis: From first dose of blinatumomab to the data cutoff date of 12 April 2019; maximum time on follow-up for OS was 14.7 months. Final analysis: From first dose of blinatumomab to end of study; maximum time on follow-up for OS was 25.7 months
Kaplan-Meier Estimate for Relapse-Free Survival (RFS)
Relapse-free survival time was calculated from the first onset of CR/CRh\* within the first 2 cycles until the documented hematological relapse, extra-medullary disease, or death due to any cause, whichever occurred first. Participants who were still alive and relapse-free were censored at the date of last disease assessment. Months were calculated as days from the first onset of CR/CRh\* within the 2 cycles until the documented hematological relapse/extra-medullary disease/death/censor date, divided by 30.5. Results for both the interim and final analysis are reported.
Time frame: Interim Analysis: From first onset of CR/CRh* to the data cutoff date of 12 April 2019; maximum time on follow-up for RFS was 12.4 months. Final Analysis: From first onset of CR/CRh* to end of study; maximum time on follow-up for RFS was 18.1 months.
Percentage of Participants With Minimal Residual Disease (MRD) Response During the First Two Treatment Cycles
The detection of MRD (the presence of a low number of leukemic cells that are not detectable by light microscopy) after induction therapy and/or consolidation therapy is an independent prognostic factor for poor outcome of ALL. Participants highly responsive to chemotherapy with a MRD-level \< 1 × 10\^-4 leukemic cells detectable by flow cytometry induced by induction treatment, have a favorable prognosis. MRD response is defined as \< 1 ×10\^-4 leukemic cells detectable as measured by flow cytometry. MRD complete response is defined as having no detectable leukemic cells by flow cytometry. Results for both the interim and final analysis are reported.
Time frame: Within 2 cycles of treatment (12 weeks)
Percentage of Participants Who Received an Allogenic Hematopoietic Stem Cell Transplant (alloHSCT) After Achieving CR/CRh* During Treatment
Percentage of participants who underwent allogenic HSCT while in remission among those who responded to treatment by achieving CR/CRh\* during treatment. Results for both the interim and final analysis are reported.
Time frame: Interim analysis: Up to the data cutoff date of 12 April 2019; maximum time on follow-up was 14.7 months. Final analysis: Up to the end of study; maximum time on follow-up was 25.7 months.
100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplant
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 still alive 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: 100 days after HSCT
Kaplan-Meier Estimates for Time to a ≥ Ten-Point Decrease From Baseline in Global Health Status Quality of Life
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, and 9 symptom scales/items. The GHS is reported in this outcome. For the GHS, scores range from 0 to 100 with a high score indicating better global health status/functioning. A ≥ 10-point decrease from baseline indicates a deterioration in quality of life. Months are calculated from start of blinatumomab date to deterioration/censor date, divided by 30.5.
Time frame: EORTC QLQ C30 was completed on days 1, 8, 15, and 29 during Cycle 1; days 1, 15, and 29 during cycle 2 and each consolidation cycle, and at the SFU visit (30 days after last dose).
Number of Participants With Treatment-Emergent Adverse Events (TEAE)
Adverse events (AEs) were evaluated for severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, as follows: Grade 1 - Mild AE; Grade 2 - Moderate AE; Grade 3 - Severe AE; Grade 4 - Life-threatening or disabling AE; Grade 5 - Death. 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 day 1 to 30 days after last infusion of blinatumomab; median (min, max) treatment duration was 30.9 (1, 142) days.
Number of Participants With Treatment-Emergent Treatment-Related Adverse Events (TEAE)
Adverse events (AEs) were evaluated for severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, 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 day 1 to 30 days after last infusion of blinatumomab; median (min, max) treatment duration was 30.9 (1, 142) days.
Participants With Anti-Blinatumomab Antibody Formation
Anti-blinatumomab binding antibodies were evaluated with a validated blinatumomab anti-drug antibody assay.
Time frame: Cycle 2, day 29 (after the completion of Cycle 2) and the SFU visit (30 days after last dose of blinatumomab)
This study was conducted at 23 centers in China. The study included a treatment period, a safety follow-up (SFU) visit 30 days after last dose and a follow-up period.
| Milestone | Blinatumomab |
|---|---|
| Started | 121 |
| Received blinatumomab | 120 |
| Interim analysis set | 90 |
| Completed | 23 |
| Not completed | 98 |
| Withdrew: Withdrawal by subject | 10 |
| Withdrew: Death | 80 |
| Withdrew: Lost to follow-up | 8 |
A CR is defined as having ≤ 5% blasts in the bone marrow, no evidence of disease, and full recovery of peripheral blood counts (platelets \> 100,000/μL, and absolute neutrophil count \[ANC\] \> 1,000/μL). CRh\* is defined as ≤ 5% blasts in the bone marrow, no evidence of disease and partial recovery of peripheral blood counts: platelets \> 50,000/μl, and ANC \> 500/μl. CR/CRh\* rate is defined as the percentage of participants who achieve CR/CRh\* within 2 cycles of treatment with blinatumomab. Participants without response assessment were accounted for in the denominator when calculating the response rate, ie, these participants were counted as non-responders. The interim analysis was to become the primary analysis by meeting pre-specified efficacy and safety criteria based on an O'Brien-Fleming alpha spending function with the critical boundary 42.2%. Results for both the interim and final analysis are reported.
| percentage of participants | Blinatumomab |
|---|---|
| Interim Analysis | 45.6 (35.0 to 56.4) |
| Final Analysis | 48.3 (39.1 to 57.6) |
A CR is defined as having ≤ 5% blasts in the bone marrow, no evidence of disease, and full recovery of peripheral blood counts (platelets \> 100,000/μL, and absolute neutrophil count \[ANC\] \> 1,000/μL). CR rate is defined as the percentage of participants who achieved CR within 2 cycles of treatment with blinatumomab. Participants without response assessment were accounted for in the denominator when calculating the response rate, ie, these participants were counted as non-responders. Results for both the interim and final analysis are reported.
| percentage of participants | Blinatumomab |
|---|---|
| Interim Analysis | 41.1 (30.8 to 52.0) |
| Final Analysis | 43.3 (34.3 to 52.7) |
CRi is defined as ≤ 5% blasts in the bone marrow, no evidence of disease and incomplete recovery of peripheral blood counts: platelets \> 100,000/μl or ANC \> 1,000/μl (but not both). CR/CRh\*/CRi rate is defined as the percentage of participants who achieve CR/CRh\*/CRi within 2 cycles of treatment with blinatumomab. Participants without response assessment were accounted for in the denominator when calculating the response rate, ie, these participants were counted as non-responders. Results for both the interim and final analysis are reported.
| percentage of participants | Blinatumomab |
|---|---|
| Interim Analysis | 47.8 (37.1 to 58.6) |
| Final Analysis | 50.0 (40.7 to 59.3) |
Blinatumomab serum concentration was quantified using a validated enzyme- linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 pg/mL. Blinatumomab serum steady-state concentrations (Css) was summarized as the average of the observed concentrations collected after 24 hours from the start of continuous IV infusion for each dose level. Cycle 1 day 2 values represent Css for the initial dose of blinatumomab (9 µg/day). Values collected from other time points were used to calculate Css of 28 µg/day dose in their respective cycles.
| pg/mL | Blinatumomab |
|---|---|
| Cycle 1: 9 μg/day | 103 ± 41 |
| Cycle 1: 28 μg/day | 416 ± 72 |
| Cycle 2: 28 μg/day | 634 ± 21 |
Systemic clearance (CL) calculated as the average CL value during cycle 1 and cycle 2, where CL = infusion rate (μg/hour) / Css
| L/hour | Blinatumomab |
|---|---|
| Pharmacokinetic (PK) Parameter: Clearance | 2.86 ± 57 |
Terminal half-life (t1/2,z) calculated as t1/2,z = ln(2)/lambda-z, where lambda-z was the first-order rate constant estimated via linear regression of the terminal log-linear decay phase from day 29 post-end of infusion collections.
| hours | Blinatumomab |
|---|---|
| Pharmacokinetic (PK) Parameter: Terminal Half-Life | 2.22 ± 31 |
The volume of distribution (Vz) was calculated as Vz = CL/lambda-z, where lambda-z was the first-order rate constant estimated based on cycle 1 day 29 collections via linear regression of the terminal log-linear decay phase as determined from the noncompartmental analysis and where CL was the CL averaged over multiple cycles. Volume of distribution was estimated for participants who have sufficient evaluable PK data.
| liters | Blinatumomab |
|---|---|
| Pharmacokinetic (PK) Parameter: Volume of Distribution | 7.15 ± 61 |
Overall survival time was calculated from the time of first infusion of blinatumomab until death due to any cause. Participants still alive were censored at the date last known to be alive up until the data cut-off date (interim analysis) or end of study date (final analysis). Months are calculated as days from the first treatment to death/censor date, divided by 30.5. Results for both the interim and final analysis are reported.
| months | Blinatumomab |
|---|---|
| Interim Analysis | 9.2 (6.5 to 11.7) |
| Final Analysis | 9.1 (7.2 to 11.7) |
Relapse-free survival time was calculated from the first onset of CR/CRh\* within the first 2 cycles until the documented hematological relapse, extra-medullary disease, or death due to any cause, whichever occurred first. Participants who were still alive and relapse-free were censored at the date of last disease assessment. Months were calculated as days from the first onset of CR/CRh\* within the 2 cycles until the documented hematological relapse/extra-medullary disease/death/censor date, divided by 30.5. Results for both the interim and final analysis are reported.
| months | Blinatumomab |
|---|---|
| Interim Analysis | 4.3 (3.2 to 9.4) |
| Final Analysis | 5.4 (3.9 to 6.1) |
The detection of MRD (the presence of a low number of leukemic cells that are not detectable by light microscopy) after induction therapy and/or consolidation therapy is an independent prognostic factor for poor outcome of ALL. Participants highly responsive to chemotherapy with a MRD-level \< 1 × 10\^-4 leukemic cells detectable by flow cytometry induced by induction treatment, have a favorable prognosis. MRD response is defined as \< 1 ×10\^-4 leukemic cells detectable as measured by flow cytometry. MRD complete response is defined as having no detectable leukemic cells by flow cytometry. Results for both the interim and final analysis are reported.
| percentage of participants | Blinatumomab |
|---|---|
| Interim Analysis: MRD Response | 82.9 (67.9 to 92.8) |
| Interim Analysis: MRD Complete Response | 2.4 (0.1 to 12.9) |
| Final Analysis: MRD Response | 84.5 (72.6 to 92.7) |
| Final Analysis: MRD Complete Response | 1.7 (0.0 to 9.2) |
Percentage of participants who underwent allogenic HSCT while in remission among those who responded to treatment by achieving CR/CRh\* during treatment. Results for both the interim and final analysis are reported.
| percentage of participants | Blinatumomab |
|---|---|
| Interim Analysis | 22.0 (10.6 to 37.6) |
| Final Analysis | 27.6 (16.7 to 40.9) |
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 still alive 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.
| percentage of participants | Blinatumomab |
|---|---|
| Interim Analysis | 0.0 (NA to NA) |
| Final Analysis | 6.7 (1.0 to 38.7) |
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, and 9 symptom scales/items. The GHS is reported in this outcome. For the GHS, scores range from 0 to 100 with a high score indicating better global health status/functioning. A ≥ 10-point decrease from baseline indicates a deterioration in quality of life. Months are calculated from start of blinatumomab date to deterioration/censor date, divided by 30.5.
| months | Blinatumomab |
|---|---|
| Interim Analysis | 1.6 (1.0 to NA) |
| Final Analysis | 3.7 (1.1 to NA) |
Adverse events (AEs) were evaluated for severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, as follows: Grade 1 - Mild AE; Grade 2 - Moderate AE; Grade 3 - Severe AE; Grade 4 - Life-threatening or disabling AE; Grade 5 - Death. 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.
| Participants | Blinatumomab |
|---|---|
| Any TEAE | 120 |
| TEAE Grade ≥ 3 | 115 |
| Serious AE | 40 |
| TEAE leading to drug discontinuation | 18 |
| Serious AE leading to drug discontinuation | 12 |
| TEAE leading to drug interruption | 31 |
| Serious AE leading to drug interruption | 13 |
| Fatal AE | 11 |
Adverse events (AEs) were evaluated for severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, 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.
| Participants | Blinatumomab |
|---|---|
| Any Treatment-related TEAE | 118 |
| Related TEAE Grade ≥ 3 | 99 |
| Related Serious AE (SAE) | 29 |
| Related TEAE leading to drug discontinuation | 16 |
| Related SAE leading to drug discontinuation | 11 |
| Related TEAE leading to drug interruption | 25 |
| Related SAE leading to drug interruption | 10 |
| Related fatal AE | 6 |
Anti-blinatumomab binding antibodies were evaluated with a validated blinatumomab anti-drug antibody assay.
| Participants | Blinatumomab |
|---|---|
| Binding antibody positive at anytime | 0 |
| Neutralizing antibody positive at anytime | 0 |
Collected over Mortality data are reported from enrollment to the end of study, maximum time on study was 26 months. Adverse events are reported from day 1 to 30 days after last infusion of blinatumomab; the median (min, max) treatment duration was 30.9 (1, 142) days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Blinatumomab | 81/121 (66.9%) | 40/120 (33.3%) | 120/120 (100%) |
| Event | Blinatumomab |
|---|---|
| Cytokine release syndromeImmune system disorders | 5/120 |
| PneumoniaInfections and infestations | 5/120 |
| Liver injuryHepatobiliary disorders | 3/120 |
| Central nervous system leukaemiaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 3/120 |
| AnaemiaBlood and lymphatic system disorders | 2/120 |
| Respiratory tract infectionInfections and infestations | 2/120 |
| Platelet count decreasedInvestigations | 2/120 |
| Acute lymphocytic leukaemiaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/120 |
| Haemorrhage intracranialNervous system disorders | 2/120 |
| Disseminated intravascular coagulationBlood and lymphatic system disorders | 1/120 |
| Event | Blinatumomab |
|---|---|
| AnaemiaBlood and lymphatic system disorders | 76/120 |
| Cytokine release syndromeImmune system disorders | 71/120 |
| White blood cell count decreasedInvestigations | 65/120 |
| HypokalaemiaMetabolism and nutrition disorders | 62/120 |
| C-reactive protein increasedInvestigations | 60/120 |
| Neutrophil count decreasedInvestigations | 58/120 |
| PyrexiaGeneral disorders | 57/120 |
| Lymphocyte count decreasedInvestigations | 57/120 |
| Blood lactate dehydrogenase increasedInvestigations | 54/120 |
| Platelet count decreasedInvestigations | 53/120 |
Participants enrolled in the study who received at least 1 infusion of blinatumomab.
| Age, Continuous(years) | Blinatumomab |
|---|---|
| Mean | 35.4 ± 15.2 |
| Age, Customized(Participants) | Blinatumomab |
|---|---|
| < 35 years | 71 |
| ≥ 35 to < 55 years | 31 |
| ≥ 55 years | 18 |
| Age, Customized(Participants) | Blinatumomab |
|---|---|
| < 65 years | 115 |
| ≥ 65 to < 75 years | 5 |
| ≥ 75 years | 0 |
| Sex: Female, Male(Participants) | Blinatumomab |
|---|---|
| Female | 64 |
| Male | 56 |
| Race (NIH/OMB)(Participants) | Blinatumomab |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 120 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Age at Diagnosis(years) | Blinatumomab |
|---|---|
| Mean | 34.78 ± 15.1 |
| Eastern Cooperative Oncology Group (ECOG) Performance Scale(Participants) | Blinatumomab |
|---|---|
| Status 0 | 43 |
| Status 1 | 53 |
| Status 2 | 24 |
| Status > 2 | 0 |
| Key Entry Criterion(Participants) | Blinatumomab |
|---|---|
| Criteria #1 | 70 |
| Criteria #2 | 10 |
| Criteria #3 | 40 |
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Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting information: Study protocol, Sap, Icf, Csr
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