A Phase 3 interventional study of Blinatumomab and Dexamethasone in Leukemia, Acute Lymphoblastic, sponsored by Amgen. Completed at 103 sites in 24 countries. Open to participants aged 0 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by Amgen · Phase 3, Interventional, and Treatment
B-precursor ALL is an aggressive malignant disease. Therapy is usually stratified according to risk characteristics to ensure that appropriate treatment is administered to patients with high-risk of relapse. In general, pediatric treatment regimens are more intense than those employed in adults and include courses of combination chemotherapy. Standard of care chemotherapy is associated with considerable toxicity. There is a lack of novel treatment options for subjects who relapse or are refractory to treatment. Therefore, innovative therapeutic approaches are urgently needed. Blinatumomab is a bispecific single-chain antibody construct designed to link B cells and T cells resulting in T cell activation and a cytotoxic T cell response against CD19 expressing cells. This study will evaluate the event-free survival (EFS) after treatment with blinatumomab when compared to standard of care (SOC) chemotherapy. The effect of blinatumomab on overall survival and reduction of minimal residual disease compared to SOC chemotherapy will also be investigated.
Patients will be randomized in a 1:1 ratio to receive either one cycle of blinatumomab or one block of standard high-risk consolidation chemotherapy. Blinatumomab is administered as a continuous intravenous infusion (CIVI). One cycle of blinatumomab treatment includes 4 weeks of CIVI of blinatumomab. After completing consolidation therapy, the patients should undergo alloHSCT depending on their bone marrow status. The patients will be followed up until the last subject on study is 36 months following alloHSCT or has died, whichever is first.
2,061 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 490 are open to participants now.
This study's enrollment of 111 is above the median of 40 across 1,653 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.
Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
One week of treatment with HC3 followed by 3 weeks of no treatment. The standard intensive consolidation chemotherapy course HC3 includes dexamethasone (10 mg/m\^2/day intravenous \[IV\] on Days 1-6), vincrisitne (1.5 mg/m\^2/day IV on Days 1 and 6), daunorubicin (30 mg/m\^2 IV over 24 hours on Day 5), methotrexate (1 g/m\^2 IV over 36 hours on Day 1), ifosfamide (800 mg/m\^2 IV for 1 hour on Days 2-4), and pegylated \[PEG\]-asparaginase (1000 U/m\^2 IV for 2 hours or intramuscularly \[IM\] on Day 6) or, if allergic, erwinia-asparaginase (20,000 units/m\^2 IV or IM every 48 hours for a total of 6 doses).
Drug: Dexamethasone · Drug: Vincrisitne · Drug: Daunorubicin · Drug: Methotrexate · Drug: Ifosfamide · Drug: PEG-asparaginase · Drug: Erwinia-asparaginase
15 μg/m\^2/day as a continuous intravenous infusion (CIVI) for 4 weeks
Drug: Blinatumomab
15 μg/m\^2/day as a continuous intravenous infusion (CIVI) for 4 weeks
Also known as: Blincyto, AMG103
10 mg/m\^2/day intravenous (IV) on Days 1-6
1.5 mg/m\^2/day IV on Days 1 and 6
30 mg/m\^2 IV over 24 hours on Day 5
1 g/m\^2 IV over 36 hours on Day 1
800 mg/m\^2 IV for 1 hour on Days 2-4
1000 U/m\^2 IV for 2 hours or intramuscularly (IM) on Day 6
In case of allergic reaction to PEG-asparaginase, participants could change to erwinia-asparaginase, 20,000 units/m2 every 48 hours for a total of 6 doses
Kaplan Meier Estimate: Event-Free Survival (EFS; Primary Analysis)
EFS is calculated from the time of randomization until the date of relapse or M2 marrow (representative bone marrow aspirate or biopsy with ≥ 5% and \< 25% blasts) after having achieved a complete remission (CR), failure to achieve a CR at the end of treatment, second malignancy, or death due to any cause, whichever occurs first. Participants who failed to achieve a CR following treatment with investigational product (IP) or who died before the disease assessment at the end of treatment were considered treatment failures and assigned an EFS duration of 1 day. Participants still alive and event-free were censored on their last disease assessment date. Participants were said to be in CR when they had the following: * M1 marrow * Peripheral blood without blasts * Absence of extramedullary leukemic involvement Months are calculated as days from randomization date to event/censor date, divided by 30.5.
Time frame: As of the primary analysis data cutoff date (17 July 2019), overall median follow-up time for EFS was 22.4 months.
Kaplan Meier Estimate: EFS (Final Analysis)
EFS is calculated from the time of randomization until the date of relapse or M2 marrow after having achieved a CR, failure to achieve a CR at the end of treatment, second malignancy, or death due to any cause, whichever occurs first. Participants who failed to achieve a CR following treatment with IP or who died before the disease assessment at the end of treatment were considered treatment failures and assigned an EFS duration of 1 day. Participants still alive and event-free were censored on their last disease assessment date. Participants were said to be in CR when they had the following: * M1 marrow * Peripheral blood without blasts * Absence of extramedullary leukemic involvement Months are calculated as days from randomization date to event/censor date, divided by 30.5.
Time frame: At final analysis, overall median follow-up time for EFS was 51.9 months.
Kaplan Meier Estimate: Overall Survival (OS)
OS was calculated from time of randomization until death due to any cause. Participants still alive were censored at the date they were last known to be alive. Months were calculated as days from randomization date to event/censor date, divided by 30.5.
Time frame: At final analysis, overall median follow-up time for OS was 55.2 months.
Percentage of Participants With an MRD Response Within 29 Days of Treatment Initiation
At the end of the first treatment cycle (Day 29) a bone marrow aspiration/biopsy was performed and evaluated by the central MRD laboratory. MRD response was defined as MRD level \< 10\^-4, by polymerase chain reaction (PCR) or flow cytometry, at the end of treatment (Cycle 1 Day 29) with study drug. Participants who were part of the MRD Evaluable Set and were missing the end of treatment (Cycle 1 Day 29) assessment for a respective MRD assessment method were considered not to have achieved a response.
Time frame: Up to End of Treatment (Cycle 1, Day 29)
Cumulative Incidence of Relapse (CIR)
CIR estimate, presented as median months to relapse, calculated from date of achievement of first CR, using the cumulative incidence method (Fine JP, Gray RJ:1999). Deaths prior to relapse not considered related to an otherwise undocumented relapse were treated as a competing risk. Participants still alive without a date of relapse were censored at the time of last follow-up. Relapse=presence of ≥1 of the following: * isolated bone marrow relapse (M3 marrow \[representative bone marrow aspirate or biopsy with ≥25% blasts\] in the absence of extramedullary involvement) * combined bone marrow relapse (M2 \[representative bone marrow aspirate or biopsy with ≥5% and \<25% blasts\] or M3 marrow and ≥1 extramedullary manifestation of acute lymphoblastic leukemia) * central nervous system extramedullary relapse * testicular extramedullary relapse * extramedullary relapse at other sites Months were calculated as days from randomization to event/censor date, divided by 30.5.
Time frame: At final analysis, the overall maximum follow-up time was 82.0 months.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs)
Adverse event (AE): any untoward medical occurrence. Serious AE: an AE meeting at least 1 of the following serious criteria: fatal; life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; congenital anomaly/birth defect; other medically important serious event. Severity was graded according to the Common Terminology Criteria for AEs (CTCAE) version 4.03: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. Investigational product (IP) in the HC3 arm refers to dexamethasone, methotrexate, daunorubicin, erwinase, ifosfamide, asparaginase, and vincristine, and in the blinatumomab arm refers to blinatumomab. Treatment-related refers to the assessment of a relationship between IP and the event.
Time frame: From first dose of IP through the last dose of IP (up to Day 29) plus 30 days.
Number of Participants With TEAEs of Interest
TEAEs of interest included capillary leak syndrome (CLS), cytokine release syndrome (CRS), decreased immunoglobulins (DI), elevated liver enzymes (ELE), embolic and thrombotic events (ETE), infections (INF), infusion reactions without considering duration (IRWCD), medication errors (ME), neurologic events (NE), neutropenia and febrile neutropenia (NFN), pancreatitis (PNC), tumor lysis syndrome, leukoencephalopathy, immunogenicity. Severity was graded according to the CTCAE version 4.03: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death.
Time frame: From first dose of IP through the last dose of IP (up to Day 29) plus 30 days.
Number of Participants With Shifts From Baseline Grade 0 or 1 to Worst Postbaseline Grade 3 or 4 Clinical Chemistry and Hematology Values
Severity was graded according to the CTCAE version 4.03: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. Increases (↑) or decreases (↓) in laboratory value grades (Gr) from baseline (BL) to worst postbaseline (→ PB) grade are presented. NA=not available.
Time frame: Up to Day 29 (± 2 days).
Kaplan-Meier Estimate of 100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT)
The analysis of 100-day mortality after alloHSCT was assessed for participants who received an alloHSCT while in remission and did not receive any additional anti-leukemic treatment. 100-day mortality after alloHSCT was calculated relative to the date of alloHSCT. The 100-day mortality rate after alloHSCT was defined as the percentage of participants having died up to 100 days after alloHSCT, estimated using the estimated time to death in percent calculated by Kaplan-Meier methods. Participants still alive were censored at the date they were last known to be alive.
Time frame: From the date of alloHSCT until death/censor date; median follow up time was 1742.0 days for blinatumomab and 1619.0 days for HC3.
Number of Participants With Anti-Blinatumomab Antibodies Postbaseline (Blinatumomab Arm Only)
Participants receiving blinatumomab had blood samples analyzed for binding antibodies. Samples testing positive for binding antibodies were also tested for neutralizing antibodies. Participants who were binding antibody-positive or neutralizing antibody-positive post-baseline with a negative or no result at baseline are presented.
Time frame: Day 1 to Day 29.
Pharmacokinetics: Concentration at Steady State (Css) (Blinatumomab Arm Only)
Time frame: Day 1: at least 10 hours after infusion start and up to 24 hours; Day 15
Pharmacokinetics: Clearance (CL) (Blinatumomab Arm Only)
Time frame: Day 1: at least 10 hours after infusion start and up to 24 hours; Day 15
This study was conducted at 48 centers across 13 countries (Europe, Australia, Israel). The first participant was enrolled on 10 November 2015. The last participant enrolled on 30 August 2019. The primary completion date was 17 July 2019 and the study completion date was 21 November 2022.
| Milestone | HC3 Chemotherapy | Blinatumomab |
|---|---|---|
| Started | 57 | 54 |
| Participants treated | 52 | 54 |
| Participants in the primary analysis population | 54 | 54 |
| Participants in the final analysis population | 57 | 54 |
| Completed | 16 | 33 |
| Not completed | 41 | 21 |
| Withdrew: Decision by sponsor | 2 | 4 |
| Withdrew: Withdrawal by subject | 11 | 6 |
| Withdrew: Death | 27 | 10 |
| Withdrew: Lost to follow-up | 1 | 1 |
EFS is calculated from the time of randomization until the date of relapse or M2 marrow (representative bone marrow aspirate or biopsy with ≥ 5% and \< 25% blasts) after having achieved a complete remission (CR), failure to achieve a CR at the end of treatment, second malignancy, or death due to any cause, whichever occurs first. Participants who failed to achieve a CR following treatment with investigational product (IP) or who died before the disease assessment at the end of treatment were considered treatment failures and assigned an EFS duration of 1 day. Participants still alive and event-free were censored on their last disease assessment date. Participants were said to be in CR when they had the following: * M1 marrow * Peripheral blood without blasts * Absence of extramedullary leukemic involvement Months are calculated as days from randomization date to event/censor date, divided by 30.5.
| months | HC3 Chemotherapy | Blinatumomab |
|---|---|---|
| Kaplan Meier Estimate: Event-Free Survival (EFS; Primary Analysis) | 7.4 (4.5 to 12.7) | NA (12.0 to NA) |
EFS is calculated from the time of randomization until the date of relapse or M2 marrow after having achieved a CR, failure to achieve a CR at the end of treatment, second malignancy, or death due to any cause, whichever occurs first. Participants who failed to achieve a CR following treatment with IP or who died before the disease assessment at the end of treatment were considered treatment failures and assigned an EFS duration of 1 day. Participants still alive and event-free were censored on their last disease assessment date. Participants were said to be in CR when they had the following: * M1 marrow * Peripheral blood without blasts * Absence of extramedullary leukemic involvement Months are calculated as days from randomization date to event/censor date, divided by 30.5.
| months | HC3 Chemotherapy | Blinatumomab |
|---|---|---|
| Kaplan Meier Estimate: EFS (Final Analysis) | 7.8 (5.8 to 13.4) | NA (24.8 to NA) |
OS was calculated from time of randomization until death due to any cause. Participants still alive were censored at the date they were last known to be alive. Months were calculated as days from randomization date to event/censor date, divided by 30.5.
| months | HC3 Chemotherapy | Blinatumomab |
|---|---|---|
| Kaplan Meier Estimate: Overall Survival (OS) | 25.6 (17.5 to NA) | NA (NA to NA) |
At the end of the first treatment cycle (Day 29) a bone marrow aspiration/biopsy was performed and evaluated by the central MRD laboratory. MRD response was defined as MRD level \< 10\^-4, by polymerase chain reaction (PCR) or flow cytometry, at the end of treatment (Cycle 1 Day 29) with study drug. Participants who were part of the MRD Evaluable Set and were missing the end of treatment (Cycle 1 Day 29) assessment for a respective MRD assessment method were considered not to have achieved a response.
| percentage of participants | HC3 Chemotherapy | Blinatumomab |
|---|---|---|
| MRD Response by PCR | 53.1 (38.3 to 67.5) | 93.9 (83.1 to 98.7) |
| MRD Response by Flow Cytometry | 60.0 (45.9 to 73.0) | 92.6 (82.1 to 97.9) |
CIR estimate, presented as median months to relapse, calculated from date of achievement of first CR, using the cumulative incidence method (Fine JP, Gray RJ:1999). Deaths prior to relapse not considered related to an otherwise undocumented relapse were treated as a competing risk. Participants still alive without a date of relapse were censored at the time of last follow-up. Relapse=presence of ≥1 of the following: * isolated bone marrow relapse (M3 marrow \[representative bone marrow aspirate or biopsy with ≥25% blasts\] in the absence of extramedullary involvement) * combined bone marrow relapse (M2 \[representative bone marrow aspirate or biopsy with ≥5% and \<25% blasts\] or M3 marrow and ≥1 extramedullary manifestation of acute lymphoblastic leukemia) * central nervous system extramedullary relapse * testicular extramedullary relapse * extramedullary relapse at other sites Months were calculated as days from randomization to event/censor date, divided by 30.5.
| months | HC3 Chemotherapy | Blinatumomab |
|---|---|---|
| Cumulative Incidence of Relapse (CIR) | 7.9 (5.8 to 18.6) | NA (NA to NA) |
Adverse event (AE): any untoward medical occurrence. Serious AE: an AE meeting at least 1 of the following serious criteria: fatal; life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; congenital anomaly/birth defect; other medically important serious event. Severity was graded according to the Common Terminology Criteria for AEs (CTCAE) version 4.03: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. Investigational product (IP) in the HC3 arm refers to dexamethasone, methotrexate, daunorubicin, erwinase, ifosfamide, asparaginase, and vincristine, and in the blinatumomab arm refers to blinatumomab. Treatment-related refers to the assessment of a relationship between IP and the event.
| participants | HC3 Chemotherapy | Blinatumomab |
|---|---|---|
| TEAEs | 50 | 54 |
| TEAEs Grade ≥ 3 | 43 | 33 |
| Serious TEAEs | 24 | 15 |
| Fatal TEAEs | 0 | 0 |
| TEAEs Leading to Discontinuation of IP | 0 | 2 |
| TEAEs Leading to Interruption of IP | 2 | 6 |
| TRAEs | 41 | 45 |
| TRAEs Grade ≥ 3 | 33 | 9 |
| Serious TRAEs | 15 | 9 |
| Fatal TRAEs | 0 | 0 |
| TRAEs Leading to Discontinuation of IP | 0 | 2 |
| TRAEs Leading to Interruption of IP | 2 | 5 |
TEAEs of interest included capillary leak syndrome (CLS), cytokine release syndrome (CRS), decreased immunoglobulins (DI), elevated liver enzymes (ELE), embolic and thrombotic events (ETE), infections (INF), infusion reactions without considering duration (IRWCD), medication errors (ME), neurologic events (NE), neutropenia and febrile neutropenia (NFN), pancreatitis (PNC), tumor lysis syndrome, leukoencephalopathy, immunogenicity. Severity was graded according to the CTCAE version 4.03: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death.
| participants | HC3 Chemotherapy | Blinatumomab |
|---|---|---|
| CLS Events | 1 | 0 |
| CLS Events Grade ≥ 3 | 1 | 0 |
| Serious CLS Events | 1 | 0 |
| Fatal CLS Events | 0 | 0 |
| CLS Events Leading to Discontinuation of IP | 0 | 0 |
| CLS Events Leading to Interruption of IP | 0 | 0 |
| CRS Events | 1 | 2 |
| CRS Events Grade ≥ 3 | 0 | 0 |
| Serious CRS Events | 0 | 0 |
| Fatal CRS Events | 0 | 0 |
| CRS Events Leading to Discontinuation of IP | 0 | 0 |
| CRS Events Leading to Interruption of IP | 0 | 0 |
| DI Events | 6 | 9 |
| DI Events Grade ≥ 3 | 1 | 1 |
| Serious DI Events | 0 | 1 |
| Fatal DI Events | 0 | 0 |
| DI Events Leading to Discontinuation of IP | 0 | 0 |
| DI Events Leading to Interruption of IP | 0 | 0 |
| ELE Events | 15 | 7 |
| ELE Events Grade ≥ 3 | 9 | 3 |
| Serious ELE Events | 1 | 0 |
| Fatal ELE Events | 0 | 0 |
| ELE Events Leading to Discontinuation of IP | 0 | 0 |
| ELE Events Leading to Interruption of IP | 0 | 0 |
| ETE Events | 0 | 4 |
| ETE Events Grade ≥ 3 | 0 | 2 |
| Serious ETE Events | 0 | 0 |
| Fatal ETE Events | 0 | 0 |
| ETE Events Leading to Discontinuation of IP | 0 | 0 |
| ETE Events Leading to Interruption of IP | 0 | 0 |
| INF Events | 18 | 25 |
| INF Events Grade ≥ 3 | 6 | 11 |
| Serious INF Events | 6 | 4 |
| Fatal INF Events | 0 | 0 |
| IFN Events Leading to Discontinuation of IP | 0 | 0 |
| IFN Events Leading to Interruption of IP | 0 | 0 |
| IRWCD Events | 4 | 37 |
| IRWCD Events Grade ≥ 3 | 0 | 2 |
| Serious IRWCD Events | 0 | 1 |
| Fatal IRWCD Events | 0 | 0 |
| IRWCD Events Leading to Discontinuation of IP | 0 | 0 |
| IRWCD Events Leading to Interruption of IP | 0 | 0 |
| ME Events | 0 | 1 |
| ME Events Grade ≥ 3 | 0 | 0 |
| Serious ME Events | 0 | 1 |
| Fatal ME Events | 0 | 0 |
| ME Events Leading to Discontinuation of IP | 0 | 0 |
| ME Events Leading to Interruption of IP | 0 | 1 |
| NE Events | 15 | 26 |
| NE Events Grade ≥ 3 | 1 | 3 |
| Serious NE Events | 1 | 5 |
| Fatal NE Events | 0 | 0 |
| NE Events Leading to Discontinuation of IP | 0 | 2 |
| NE Events Leading to Interruption of IP | 1 | 3 |
| NFN Events | 28 | 12 |
| NFN Events Grade ≥ 3 | 27 | 11 |
| Serious NFN Events | 12 | 0 |
| Fatal NFN Events | 0 | 0 |
| NFN Events Leading to Discontinuation of IP | 0 | 0 |
| NFN Events Leading to Interruption of IP | 0 | 0 |
| PNC Events | 1 | 0 |
| PNC Events Grade ≥ 3 | 1 | 0 |
| Serious PNC Events | 1 | 0 |
| Fatal PNC Events | 0 | 0 |
| PNC Events Leading to Discontinuation of IP | 0 | 0 |
| PNC Events Leading to Interruption of IP | 0 | 0 |
| Tumour Lysis Syndrome Events | 0 | 0 |
| Leukoencephalopathy Events | 0 | 0 |
| Immunogenicity Events | 0 | 0 |
Severity was graded according to the CTCAE version 4.03: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. Increases (↑) or decreases (↓) in laboratory value grades (Gr) from baseline (BL) to worst postbaseline (→ PB) grade are presented. NA=not available.
| participants | HC3 Chemotherapy | Blinatumomab |
|---|---|---|
| Potassium ↑ BL Gr 0 → PB Gr 3 | 0 | 1 |
| Potassium ↓ BL Gr 0 → PB Gr 3 | 4 | 5 |
| Potassium ↓ BL Gr 0 → PB Gr 4 | 1 | 1 |
| Albumin ↓ BL Gr 0 → PB Gr 3 | 0 | 1 |
| Calcium ↓ BL Gr 0 → PB Gr 4 | 1 | 1 |
| Alanine Aminotransferase ↑ BL Gr 0 → PB Gr 3 | 1 | 0 |
| Alanine Aminotransferase ↑ BL Gr 1 → PB Gr 3 | 9 | 5 |
| Aspartate Aminotransferase ↑ BL Gr NA → PB Gr 3 | 1 | 0 |
| Aspartate Aminotransferase ↑ BL Gr 0 → PB Gr 3 | 2 | 0 |
| Aspartate Aminotransferase ↑ BL Gr 1 → PB Gr 3 | 5 | 1 |
| Aspartate Aminotransferase ↑ BL Gr 1 → PB Gr 4 | 1 | 0 |
| Gamma-Glutamyl Transferase ↑ BL Gr NA → PB Gr 3 | 0 | 1 |
| Gamma-Glutamyl Transferase ↑ BL Gr 0 → PB Gr 3 | 3 | 4 |
| Gamma-Glutamyl Transferase ↑ BL Gr 1 → PB Gr 3 | 6 | 2 |
| Gamma-Glutamyl Transferase ↑ BL Gr 1 → PB Gr 4 | 0 | 3 |
| Amylase ↑ BL Gr 0 → PB Gr 3 | 1 | 1 |
| Amylase ↑ BL Gr 0 → PB Gr 4 | 1 | 0 |
| Amylase ↑ BL Gr 1 → PB Gr 3 | 0 | 1 |
| Lipase ↑ BL Gr 0 → PB Gr 3 | 3 | 2 |
| Lipase ↑ BL Gr 0 → PB Gr 4 | 1 | 2 |
| Bilirubin ↑ BL Gr 0 → PB Gr 3 | 2 | 1 |
| Bilirubin ↑ BL Gr 0 → PB Gr 4 | 1 | 0 |
| Creatinine ↑ BL Gr NA → PB Gr 3 | 0 | 2 |
| Hemoglobin ↓ BL Gr 0 → PB Gr 3 | 1 | 0 |
| Hemoglobin ↓ BL Gr 1 → PB Gr 3 | 4 | 1 |
| Platelets ↓ BL Gr 0 → PB Gr 3 | 7 | 6 |
| Platelets ↓ BL Gr 0 → PB Gr 4 | 13 | 6 |
| Platelets ↓ BL Gr 1 → PB Gr 3 | 1 | 2 |
| Platelets ↓ BL Gr 1 → PB Gr 4 | 8 | 2 |
| Leukocytes ↓ BL Gr 0 → PB Gr 3 | 2 | 0 |
| Leukocytes ↓ BL Gr 0 → PB Gr 4 | 4 | 0 |
| Leukocytes ↓ BL Gr 1 → PB Gr 3 | 4 | 4 |
| Leukocytes ↓ BL Gr 1 → PB Gr 4 | 7 | 1 |
| Neutrophils ↓ BL Gr 0 → PB Gr 3 | 4 | 11 |
| Neutrophils ↓ BL Gr 0 → PB Gr 4 | 23 | 3 |
| Lymphocytes ↑ BL Gr 0 → PB Gr 3 | 0 | 1 |
| Lymphocytes ↓ BL Gr 0 → PB Gr 3 | 1 | 3 |
| Lymphocytes ↓ BL Gr 0 → PB Gr 4 | 1 | 1 |
| Lymphocytes ↓ BL Gr 1 → PB Gr 3 | 0 | 1 |
| Lymphocytes ↓ BL Gr 1 → PB Gr 4 | 1 | 2 |
The analysis of 100-day mortality after alloHSCT was assessed for participants who received an alloHSCT while in remission and did not receive any additional anti-leukemic treatment. 100-day mortality after alloHSCT was calculated relative to the date of alloHSCT. The 100-day mortality rate after alloHSCT was defined as the percentage of participants having died up to 100 days after alloHSCT, estimated using the estimated time to death in percent calculated by Kaplan-Meier methods. Participants still alive were censored at the date they were last known to be alive.
| percentage of participants | HC3 Chemotherapy | Blinatumomab |
|---|---|---|
| Kaplan-Meier Estimate of 100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT) | 5.1 (1.3 to 19.0) | 3.9 (1.0 to 14.8) |
Participants receiving blinatumomab had blood samples analyzed for binding antibodies. Samples testing positive for binding antibodies were also tested for neutralizing antibodies. Participants who were binding antibody-positive or neutralizing antibody-positive post-baseline with a negative or no result at baseline are presented.
| participants | Blinatumomab |
|---|---|
| Binding Antibody Positive | 0 |
| Neutralizing Antibody Positive | 0 |
| pg/mL | Blinatumomab |
|---|---|
| Pharmacokinetics: Concentration at Steady State (Css) (Blinatumomab Arm Only) | 884 ± 969 |
| L/hr/m^2 | Blinatumomab |
|---|---|
| Pharmacokinetics: Clearance (CL) (Blinatumomab Arm Only) | 1.14 ± 0.836 |
Collected over All-cause mortality is reported from randomization through the end of study; the median overall follow-up time was 55.2 months. Treatment-emergent adverse events are reported from the first dose of IP through the last dose of IP (up to Day 29) plus 30 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HC3 Chemotherapy | 28/57 (49.1%) | 24/52 (46.2%) | 48/52 (92.3%) |
| Blinatumomab | 11/54 (20.4%) | 15/54 (27.8%) | 54/54 (100%) |
| Event | HC3 Chemotherapy | Blinatumomab |
|---|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 9/52 | 0/54 |
| NeutropeniaBlood and lymphatic system disorders | 3/52 | 0/54 |
| ThrombocytopeniaBlood and lymphatic system disorders | 2/52 | 0/54 |
| StomatitisGastrointestinal disorders | 2/52 | 1/54 |
| Neurological symptomNervous system disorders | 0/52 | 2/54 |
| SeizureNervous system disorders | 0/52 | 2/54 |
| LeukopeniaBlood and lymphatic system disorders | 1/52 | 0/54 |
| Pancreatitis acuteGastrointestinal disorders | 1/52 | 0/54 |
| HepatotoxicityHepatobiliary disorders | 1/52 | 0/54 |
| HypertransaminasaemiaHepatobiliary disorders | 1/52 | 0/54 |
| Event | HC3 Chemotherapy | Blinatumomab |
|---|---|---|
| PyrexiaGeneral disorders | 10/52 | 43/54 |
| StomatitisGastrointestinal disorders | 27/52 | 11/54 |
| AnaemiaBlood and lymphatic system disorders | 24/52 | 13/54 |
| NauseaGastrointestinal disorders | 9/52 | 23/54 |
| HeadacheNervous system disorders | 8/52 | 20/54 |
| VomitingGastrointestinal disorders | 11/52 | 17/54 |
| NeutropeniaBlood and lymphatic system disorders | 13/52 | 5/54 |
| DiarrhoeaGastrointestinal disorders | 9/52 | 12/54 |
| ThrombocytopeniaBlood and lymphatic system disorders | 11/52 | 4/54 |
| Abdominal painGastrointestinal disorders | 11/52 | 7/54 |
The FAS included all randomized participants analyzed according to their randomized treatment assignment, regardless of the treatment received.
| Age, Continuous(years) | HC3 Chemotherapy | Blinatumomab | Total |
|---|---|---|---|
| Mean | 6.6 ± 4.3 | 7.3 ± 4.4 | 7.0 ± 4.4 |
| Sex: Female, Male(Participants) | HC3 Chemotherapy | Blinatumomab | Total |
|---|---|---|---|
| Female | 34 | 24 | 58 |
| Male | 23 | 30 | 53 |
| Ethnicity (NIH/OMB)(Participants) | HC3 Chemotherapy | Blinatumomab | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 1 | 4 |
| Not Hispanic or Latino | 54 | 53 | 107 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | HC3 Chemotherapy | Blinatumomab | Total |
|---|---|---|---|
| White | 46 | 50 | 96 |
| Other, Not Specified | 5 | 3 | 8 |
| Asian | 3 | 1 | 4 |
| Black or African American | 3 | 0 | 3 |
| Stratification Factor: Age Category(Participants) | HC3 Chemotherapy | Blinatumomab | Total |
|---|---|---|---|
| 1 to 9 years | 41 | 39 | 80 |
| Other (< 1 year and > 9 years) | 16 | 15 | 31 |
| Stratification Factor: Marrow/Minimal Residual Disease (MRD)(participants) | HC3 Chemotherapy | Blinatumomab | Total |
|---|---|---|---|
| M1 Marrow + MRD level ≥ 10^-3 | 17 | 15 | 32 |
| M1 Marrow + MRD level < 10^-3 | 36 | 35 | 71 |
| M2 Marrow | 4 | 4 | 8 |
Showing the first 100 of 103 sites across 24 countries.
Documents are hosted by the registry — open the source record to download them.
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
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Precursor Cell Lymphoblastic Leukemia-Lymphoma→
Amgen