Blinatumomab for Acute Lymphoblastic Leukemia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Medical College of Wisconsin, Milwaukee, WIAcute Lymphoblastic Leukemia+2 MoreBlinatumomab - Drug
Eligibility
< 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new therapy to see if it can reduce leukemia before a patient gets a bone marrow transplant. The hope is that it will improve the patient's chances of survival.

Eligible Conditions
  • B-cell Acute Lymphoblastic Leukemia
  • Refractory B Acute Lymphoblastic Leukemia
  • Relapsed B-cell Acute Lymphoblastic Leukemia

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Blinatumomab

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: 42 Months

42 Months
Percentage of Subjects FC-MRD Negative
Percentage of Subjects in CR
Percentage of Subjects that HTS-MRD Negative

Trial Safety

Safety Progress

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

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1
Copanlisib
1
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1
Blinatumomab

Side Effects for

HC3 Chemotherapy
53%Stomatitis
45%Anaemia
25%Neutropenia
22%Vomiting
22%Thrombocytopenia
22%Abdominal pain
20%Pyrexia
18%Nausea
18%Febrile neutropenia
18%Diarrhoea
16%Headache
16%Platelet count decreased
14%Constipation
14%Alanine aminotransferase increased
14%Epistaxis
10%Pain in extremity
10%Pruritus
10%Rhinitis
10%Hypokalaemia
10%Aspartate aminotransferase increased
8%Hypertension
8%Rash
8%Mucosal inflammation
8%Back pain
8%Aplasia
8%Hypertransaminasaemia
8%Hypotension
8%Arthralgia
6%Leukopenia
6%Abdominal pain upper
6%Oropharyngeal pain
6%Antithrombin III decreased
6%Fluid balance positive
6%Oral pain
6%Haematoma
4%Hypogammaglobulinaemia
4%Erythema
4%Fatigue
4%Neutrophil count decreased
2%Lipase increased
2%Clostridium difficile colitis
2%Septic shock
2%Pneumothorax traumatic
2%Capillary leak syndrome
2%Hepatotoxicity
2%Device related infection
2%Nasopharyngitis
2%Cough
2%Acute lymphocytic leukaemia recurrent
2%Bronchitis
2%Pancreatitis acute
2%Escherichia bacteraemia
2%Decreased appetite
2%White blood cell count decreased
2%Agitation
This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT02393859) in the HC3 Chemotherapy ARM group. Side effects include: Stomatitis with 53%, Anaemia with 45%, Neutropenia with 25%, Vomiting with 22%, Thrombocytopenia with 22%.

Trial Design

1 Treatment Group

Blinatumomab
1 of 1

Experimental Treatment

35 Total Participants · 1 Treatment Group

Primary Treatment: Blinatumomab · No Placebo Group · Phase 2

Blinatumomab
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: 42 months

Who is running the clinical trial?

Michael BurkeLead Sponsor
1 Previous Clinical Trials
3 Total Patients Enrolled
AmgenIndustry Sponsor
1,301 Previous Clinical Trials
1,330,142 Total Patients Enrolled
Michael Burke, MD1.01 ReviewsStudy Chair - Medical College of Wisconsin
Medical College of Wisconsin
4 Previous Clinical Trials
860 Total Patients Enrolled

Eligibility Criteria

Age < 65 · All Participants · 13 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You need to have a donor available and be willing to undergo high-dose chemotherapy (HCT) after receiving 1 to 2 rounds of blinatumomab as a bridge therapy.
You have completed any form of immunotherapy, such as tumor vaccines or CAR T-cell therapy, at least 42 days ago.
References

Frequently Asked Questions

Could you provide a synopsis of the research that has been done with Blinatumomab?

"As of now, there are 46 clinical trials examining blinatumomab with 9 in phase 3. Although the bulk of these studies take place in Milwaukee, WI, there are 2395 sites conducting this research worldwide." - Anonymous Online Contributor

Unverified Answer

Has Blinatumomab fulfilled the requirements to obtain FDA approval?

"The safety of Blinatumomab has been evaluated and given a score of 2, as this is only at the Phase 2 stage; no efficacy data yet exists." - Anonymous Online Contributor

Unverified Answer

Is this trial enrolling participants at the present time?

"The clinical trial is open for enrollment, as indicated by information on the clinicaltrials.gov website. This medical study was initially posted in January 2021 and most recently updated at April 2022." - Anonymous Online Contributor

Unverified Answer

What is the participant size of this clinical research?

"Affirmative. Clinicaltrials.gov's records demonstrate that this research project is actively seeking participants; it was initially posted on January 1st 2021, and the latest information update occurred April 4th 2022. 35 patients must be recruited from a single site for successful completion of the trial." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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