Blinatumomab for Acute Lymphoblastic Leukemia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Acute Lymphoblastic LeukemiaBlinatumomab - Drug
Eligibility
18+
All Sexes
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Study Summary

This trial will test the safety and effectiveness of a new cancer drug for people with a certain type of leukemia.

Eligible Conditions
  • Acute Lymphoblastic Leukemia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

19 Primary · 52 Secondary · Reporting Duration: Cycle 1 Day 1 (cycle is 34 days)

Week 28
Dose Expansion Phase: Change from baseline of quality of life as assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30)
Dose Expansion Phase: Summary scores of quality of life at each assessment as assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30)
Phase 2: Change from baseline of quality of life as assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30)
Phase 2: Summary scores of quality of life at each assessment as assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30)
Day 34
Phase 2: AUC of blinatumomab (relapsed or refractory acute lymphoblastic leukemia participants only)
Phase 2: Cmax of blinatumomab (relapsed or refractory acute lymphoblastic leukemia participants only)
Phase 2: Cmin of blinatumomab (relapsed or refractory acute lymphoblastic leukemia participants only)
Phase 2: Tmax of blinatumomab (relapsed or refractory acute lymphoblastic leukemia participants only)
Up to 29 days
Dose Escalation Phase: Number of participants who experience dose limiting toxicities (DLTs)
Number of participants who experience dose limiting toxicities (DLTs)
Phase 1: Number of participants who experience dose limiting toxicities (DLTs)
Up to 68 days
Area under the concentration-time curve (AUC) of blinatumomab
Dose Escalation Phase: Number of participants who achieve CR/CRh
Dose Expansion Phase (MRD B-ALL): Number of participants who achieve MRD <0.01%
Dose Expansion Phase (R/R B-ALL): Number of participants who achieve complete remission (CR)
Dose Expansion Phase (R/R B-ALL): Number of participants who achieve complete remission with partial hematological recovery (CRh)
Dose Expansion Phase: Relapse-Free Survival in participants who achieve CR/CRh (R/R B-ALL) and CR with MRD < 0.01% (MRD B-ALL
Maximum concentration (Cmax) of blinatumomab
Minimum concentration over the dosing interval (Cmin) of blinatumomab
Number of participants with incidence of anti-blinatumomab antibody formation
Phase 1: Number of participants who achieve complete remission, complete remission with partial hematological recovery, and or complete remission with incomplete hematological recovery
Phase 2: Number of participants who achieve complete remission, complete remission with partial hematological recovery, or complete remission with incomplete hematological recovery (CR/CRh/CRi)
Phase 2: Relapse-Free Survival in participants who achieve CR/CRh/CRi
Rate of complete remission (CR) including complete remission with partial hematological recovery (CRh)
Time to reach maximum concentration (Tmax) of blinatumomab
Week 28
Dose Escalation Phase: Area under the concentration-time curve (AUC) of blinatumomab
Dose Escalation Phase: Maximum concentration (Cmax) of blinatumomab
Dose Escalation Phase: Minimum concentration over the dosing interval (Cmin) of blinatumomab
Dose Escalation Phase: Number of participants who experience one or more adverse events (AEs)
Dose Escalation Phase: Number of participants who experience one or more serious TEAEs
Dose Escalation Phase: Number of participants who experience one or more treatment-emergent adverse events (TEAEs)
Dose Escalation Phase: Number of participants who experience one or more treatment-related treatment-emergent adverse events
Dose Escalation Phase: Number of participants with incidence of anti-blinatumomab antibody formation
Dose Escalation Phase: Time to reach maximum concentration (Tmax) of blinatumomab
Dose Expansion Phase: AUC of blinatumomab
Dose Expansion Phase: Cmax of blinatumomab
Dose Expansion Phase: Cmin of blinatumomab
Dose Expansion Phase: Duration of complete response
Dose Expansion Phase: Duration of minimal/measurable residual disease (MRD) response
Dose Expansion Phase: Number of participants who experience one or more AEs
Dose Expansion Phase: Number of participants who experience one or more TEAEs
Dose Expansion Phase: Number of participants who experience one or more serious treatment-emergent adverse event
Dose Expansion Phase: Number of participants who experience one or more treatment-related treatment-emergent adverse events
Dose Expansion Phase: Number of participants with incidence of anti-blinatumomab antibody formation
Dose Expansion Phase: Overall survival
Dose Expansion Phase: Tmax of blinatumomab
Number of participants who experience one or more adverse events (AEs)
Number of participants who experience one or more serious treatment-emergent adverse event (TEAEs)
Number of participants who experience one or more treatment-emergent adverse events (TEAEs)
Number of participants who experience one or more treatment-related treatment-emergent adverse events (TEAEs)
Phase 1: Area under the concentration-time curve (AUC) of blinatumomab
Phase 1: Maximum concentration (Cmax) of blinatumomab
Phase 1: Minimum concentration over the dosing interval (Cmin) of blinatumomab
Phase 1: Number of participants who experience one or more adverse events (AEs)
Phase 1: Number of participants who experience one or more serious TEAEs
Phase 1: Number of participants who experience one or more treatment-emergent adverse events (TEAEs)
Phase 1: Number of participants who experience one or more treatment-related treatment-emergent adverse events
Phase 1: Number of participants with incidence of anti-blinatumomab antibody formation
Phase 1: Time to reach maximum concentration (Tmax) of blinatumomab
Phase 2: AUC of blinatumomab
Phase 2: Cmax of blinatumomab
Phase 2: Cmin of blinatumomab
Phase 2: Duration of complete response
Phase 2: Duration of minimal/measurable residual disease (MRD) response
Phase 2: Number of participants who experience one or more AEs
Phase 2: Number of participants who experience one or more TEAEs
Phase 2: Number of participants who experience one or more serious treatment-emergent adverse event
Phase 2: Number of participants who experience one or more treatment-related treatment-emergent adverse events
Phase 2: Number of participants with incidence of anti-blinatumomab antibody formation
Phase 2: Overall survival
Phase 2: Tmax of blinatumomab

Trial Safety

Safety Progress

1 of 3

Side Effects for

Blinatumomab
80%Pyrexia
41%Nausea
35%Headache
30%Vomiting
22%Anaemia
20%Diarrhoea
17%Stomatitis
17%Mucosal inflammation
13%Hypertension
13%Rash
13%Abdominal pain
13%Platelet count decreased
11%Hypokalaemia
11%Erythema
11%Pruritus
11%Hypogammaglobulinaemia
11%Hypotension
9%Neutropenia
9%Epistaxis
9%Tremor
9%Constipation
9%Neutrophil count decreased
7%Agitation
7%Cough
7%Thrombocytopenia
7%Abdominal pain upper
7%Fluid overload
7%Immunodeficiency
7%White blood cell count decreased
7%Alanine aminotransferase increased
6%Nasopharyngitis
6%Paronychia
6%Back pain
6%Rash maculo-papular
6%Febrile neutropenia
6%Fatigue
6%Petechiae
6%Urticaria
6%Decreased appetite
4%Seizure
4%Aplasia
4%Pain in extremity
4%Oropharyngeal pain
4%Neurological symptom
4%Fluid balance positive
4%Aspartate aminotransferase increased
2%Klebsiella infection
2%Perineal cellulitis
2%Accidental overdose
2%Oral pain
2%Haematoma
2%Catheter placement
2%Hypertransaminasaemia
2%Rhinitis
2%Antithrombin III decreased
2%Neurological examination abnormal
2%Body temperature increased
2%Nervous system disorder
2%Blood immunoglobulin G decreased
2%Herpes virus infection
This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT02393859) in the Blinatumomab ARM group. Side effects include: Pyrexia with 80%, Nausea with 41%, Headache with 35%, Vomiting with 30%, Anaemia with 22%.

Trial Design

6 Treatment Groups

Dose Expansion Phase: Blinatumomab
1 of 6
Dose Escalation Phase: Blinatumomab
1 of 6
Blinatumomab: Dose expansion
1 of 6
Blinatumomab: Dose escalation
1 of 6
Phase 1: Blinatumomab (Dose escalation)
1 of 6
Phase 2: Blinatumomab (Dose expansion)
1 of 6

Experimental Treatment

130 Total Participants · 6 Treatment Groups

Primary Treatment: Blinatumomab · No Placebo Group · Phase 1

Dose Expansion Phase: Blinatumomab
Drug
Experimental Group · 1 Intervention: Blinatumomab · Intervention Types: Drug
Dose Escalation Phase: Blinatumomab
Drug
Experimental Group · 1 Intervention: Blinatumomab · Intervention Types: Drug
Blinatumomab: Dose expansion
Drug
Experimental Group · 1 Intervention: Blinatumomab · Intervention Types: Drug
Blinatumomab: Dose escalation
Drug
Experimental Group · 1 Intervention: Blinatumomab · Intervention Types: Drug
Phase 1: Blinatumomab (Dose escalation)
Drug
Experimental Group · 1 Intervention: Blinatumomab · Intervention Types: Drug
Phase 2: Blinatumomab (Dose expansion)
Drug
Experimental Group · 1 Intervention: Blinatumomab · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blinatumomab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: cycle 1 day 1 (cycle is 34 days)

Who is running the clinical trial?

AmgenLead Sponsor
1,296 Previous Clinical Trials
1,328,688 Total Patients Enrolled
MDStudy DirectorAmgen
838 Previous Clinical Trials
897,789 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be 18 years old or older.
You have either been unresponsive to initial treatment interventions, or are in a state of relapse that has not responded to any subsequent therapies.
CR1 attained during initial treatment followed by relapse while on or after follow-up therapy defines the first recurrence.
You have not achieved a complete remission from standard induction therapy.
You have not achieved remission after secondary treatment.
Relapse occurring after attaining a second complete remission (CR2) in the initial or subsequent salvage therapy is categorized as a secondary relapse.
You have not achieved a complete response to salvage.
You have experienced relapse or non-responsiveness to treatment following initial salvage therapy.
You have had a relapse following allogenic HSCT.
You have a Bone Marrow blast count of at least 5%.