Blinatumomab for Acute Lymphoblastic Leukemia

Phase-Based Progress Estimates

Effectiveness

Safety

Acute Lymphoblastic LeukemiaBlinatumomab - Drug

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Eligibility

18+

All Sexes

What conditions do you have?

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Eligibility

18+

All Sexes

What conditions do you have?

Select

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

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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

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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