Blinatumomab for B-cell Acute Lymphoblastic Leukemia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
B-cell Acute Lymphoblastic Leukemia+2 MoreBlinatumomab - Drug
Eligibility
< 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether a new treatment for leukemia, which uses cells from another person, followed by a different drug, can help reduce relapse rates and improve survival.

Eligible Conditions
  • B-cell Acute Lymphoblastic Leukemia
  • B-Cell Acute Lymphoblastic Leukemia (ALL), Childhood
  • Childhood Acute Lymphoblastic Leukemia (ALL)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 12 Secondary · Reporting Duration: Days +19, +91, +135 and +180 post-HCT

Year 1
Patient Reported Outcomes
Year 1
Engraftment
Day +100 post-HCT
Percentage of patients who are able to receive the blinatumomab infusion [Feasibility]
Year 1
Acute & Chronic GVHD
Year 1
Primary Graft Failure
Year 1
Secondary Graft Failure
Year 1
Disease Free Survival
Overall Survival
Year 1
Treatment Related Mortality
Day of HCT to Day +180 post-HCT
Cumulative incidence of treatment-related adverse events [Tolerability]
Year 1
Relapse
Days +19, +91, +135 and +180 post-HCT
Analysis of immune cell phenotyping
Functional assessment of lymphocyte subsets
Serum cytokine analysis
Year 1
Persistence of Minimal Residual Disease (MRD) Negativity
Day 0
Length of Stay

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

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%Fatigue
6%Nasopharyngitis
6%Paronychia
6%Back pain
6%Rash maculo-papular
6%Febrile neutropenia
6%Petechiae
6%Urticaria
6%Decreased appetite
4%Seizure
4%Oropharyngeal pain
4%Aplasia
4%Pain in extremity
4%Neurological symptom
4%Fluid balance positive
4%Aspartate aminotransferase increased
2%Oral pain
2%Hypertransaminasaemia
2%Klebsiella infection
2%Perineal cellulitis
2%Catheter placement
2%Antithrombin III decreased
2%Haematoma
2%Accidental overdose
2%Rhinitis
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

2 Treatment Groups

Alpha/beta T-cell and B-cell Depleted, Myeloablative HCT
1 of 2
Alpha/beta T-cell and B-cell Depleted, Reduced Intensity HCT
1 of 2

Experimental Treatment

25 Total Participants · 2 Treatment Groups

Primary Treatment: Blinatumomab · No Placebo Group · Phase 2

Alpha/beta T-cell and B-cell Depleted, Myeloablative HCTExperimental Group · 2 Interventions: Blinatumomab, Alpha/Beta T-cell and B-cell depleted HCT · Intervention Types: Drug, Device
Alpha/beta T-cell and B-cell Depleted, Reduced Intensity HCTExperimental Group · 2 Interventions: Blinatumomab, Alpha/Beta T-cell and B-cell depleted HCT · Intervention Types: Drug, Device
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: days +19, +91, +135 and +180 post-hct

Who is running the clinical trial?

AmgenIndustry Sponsor
1,296 Previous Clinical Trials
1,328,559 Total Patients Enrolled
2 Trials studying B-cell Acute Lymphoblastic Leukemia
35 Patients Enrolled for B-cell Acute Lymphoblastic Leukemia
University of Wisconsin, MadisonOTHER
1,070 Previous Clinical Trials
2,576,616 Total Patients Enrolled
1 Trials studying B-cell Acute Lymphoblastic Leukemia
36 Patients Enrolled for B-cell Acute Lymphoblastic Leukemia
Medical College of WisconsinLead Sponsor
566 Previous Clinical Trials
1,154,143 Total Patients Enrolled
Rachel Phelan, MD, MPHStudy ChairMedical College of Wisconsin

Eligibility Criteria

Age < 65 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have had a first remission with persistent disease identified as end of consolidation (EOC) MRD > 0.01%.
You must be younger than 25 years of age.\n
You have had a relapse or greater.