Blinatumomab for B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1+8 More
Blinatumomab - Biological
Eligibility
65+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying the side effects and efficacy of blinatumomab and combination chemotherapy or dasatinib and prednisone in treating older patients with acute lymphoblastic leukemia.

Eligible Conditions
  • B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
  • Recurrent Acute Lymphoblastic Leukemia
  • B Acute Lymphoblastic Leukemia
  • Refractory Acute Lymphoblastic Leukemia (ALL)
  • Acute Lymphoblastic Leukemia (ALL)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1

Study Objectives

2 Primary · 7 Secondary · Reporting Duration: Up to 10 years

Year 10
Disease-free survival
Year 3
Overall survival (Cohort I)
Up to 10 years
Complete response (complete remission + complete remission with incomplete count recovery) rate (Cohort I)
Incidence of toxicity
Minimal residual disease negativity
Overall survival (Cohort II)
Response rates (Cohort II)
Time to achieve minimal residual disease negativity
Day 42
Incidence of dose-limiting toxicity (Cohort II)

Trial Safety

Safety Progress

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

Other trials for B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1

Side Effects for

Blinatumomab
63%Anaemia
59%Cytokine release syndrome
54%White blood cell count decreased
52%Hypokalaemia
50%C-reactive protein increased
48%Neutrophil count decreased
48%Lymphocyte count decreased
48%Pyrexia
45%Blood lactate dehydrogenase increased
44%Platelet count decreased
32%Leukopenia
31%Thrombocytopenia
28%Blood immunoglobulin G decreased
28%Gamma-glutamyltransferase increased
27%Aspartate aminotransferase increased
25%Neutropenia
24%Fibrin D dimer increased
23%Hypocalcaemia
23%Alanine aminotransferase increased
22%Pneumonia
21%Lung infection
21%White blood cell count increased
20%Hyperuricaemia
19%Hyperglycaemia
19%Blood bilirubin increased
18%Blood albumin decreased
18%Interleukin level increased
18%Hypoalbuminaemia
18%Hypoproteinaemia
18%Monocyte count decreased
18%Blood glucose increased
18%Protein total decreased
18%Upper respiratory tract infection
18%Globulins decreased
18%Procalcitonin increased
17%Blood immunoglobulin A decreased
16%Neutrophil count increased
15%Bilirubin conjugated increased
15%Blood immunoglobulin M decreased
15%Blood alkaline phosphatase increased
15%Lymphopenia
15%Immunoglobulins decreased
14%Alpha hydroxybutyrate dehydrogenase increased
14%Reticulocyte count increased
13%Leukocytosis
13%Cough
13%Lymphocyte count increased
13%Blood fibrinogen increased
13%Constipation
13%Diarrhoea
13%Hypertriglyceridaemia
13%Vomiting
13%Blood uric acid increased
12%Blood triglycerides increased
12%Arthralgia
12%Hyponatraemia
12%Blood phosphorus increased
12%Serum ferritin increased
12%Nausea
12%Hypophosphataemia
12%Liver injury
11%Rash
11%Blood calcium decreased
11%Red blood cell count decreased
11%Asthenia
11%Coagulopathy
11%Oedema peripheral
10%Hepatic function abnormal
10%Activated partial thromboplastin time prolonged
9%Dizziness
9%Insomnia
9%Total bile acids increased
9%Lymphocyte percentage decreased
8%Blood fibrinogen decreased
8%Epistaxis
8%Hypomagnesaemia
8%Reticulocyte percentage increased
8%Blood potassium decreased
8%Bone pain
8%Blood urea increased
8%Headache
8%Neutrophil percentage decreased
8%Oropharyngeal pain
8%Abdominal distension
7%Neutrophil percentage increased
7%Hyperlipidaemia
7%Infection
7%Eosinophil count decreased
7%Haemoglobin decreased
7%Fibrin degradation products increased
7%Decreased appetite
7%Hypoglycaemia
6%Hypercalcaemia
6%Urinary tract infection
6%Blast cell count increased
6%Hypotension
6%Mouth ulceration
6%Haematocrit decreased
6%Beta 2 microglobulin increased
6%Reticulocyte count decreased
5%Toothache
5%Blood cholesterol increased
5%Monocyte count increased
5%Folliculitis
5%Blood phosphorus decreased
5%Hypoxia
5%Pain in extremity
5%International normalised ratio increased
5%Monocyte percentage decreased
5%Pruritus
5%Lymphocyte percentage increased
5%Chest pain
5%Albumin globulin ratio increased
5%Anion gap increased
5%Lymphocytosis
5%Haemorrhoids
5%Blood disorder
5%Sinus tachycardia
3%Central nervous system leukaemia
2%Acute lymphocytic leukaemia
2%Haemorrhage intracranial
2%Respiratory tract infection
1%Cardiac failure acute
1%Disseminated intravascular coagulation
1%Neutropenic infection
1%Candida infection
1%Device related infection
1%Cytomegalovirus urinary tract infection
1%Transformation to acute myeloid leukaemia
1%Cardiac arrest
1%Epilepsy
1%Fungaemia
1%Pneumonitis
1%Respiratory failure
1%Pancreatitis acute
1%Hypoacusis
1%Gastrointestinal haemorrhage
1%Sepsis
1%Interstitial lung disease
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03476239) in the Blinatumomab ARM group. Side effects include: Anaemia with 63%, Cytokine release syndrome with 59%, White blood cell count decreased with 54%, Hypokalaemia with 52%, C-reactive protein increased with 50%.

Trial Design

2 Treatment Groups

Cohort I (blinatumomab, POMP)
1 of 2
Cohort II (dasatinib, prednisone, blinatumomab)
1 of 2
Experimental Treatment

57 Total Participants · 2 Treatment Groups

Primary Treatment: Blinatumomab · No Placebo Group · Phase 2

Cohort I (blinatumomab, POMP)Experimental Group · 8 Interventions: Mercaptopurine, Methotrexate, Vincristine Sulfate, Laboratory Biomarker Analysis, Vincristine, Blinatumomab, Prednisone, Methotrexate Sodium · Intervention Types: Drug, Drug, Drug, Other, Drug, Biological, Drug, Drug
Cohort II (dasatinib, prednisone, blinatumomab)Experimental Group · 4 Interventions: Laboratory Biomarker Analysis, Blinatumomab, Prednisone, Dasatinib · Intervention Types: Other, Biological, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mercaptopurine
FDA approved
Methopterin
Not yet FDA approved
Sulfate ion
Not yet FDA approved
Vincristine
FDA approved
Blinatumomab
FDA approved
Cortisone
Not yet FDA approved
Methotrexate
FDA approved
Dasatinib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 10 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
12,990 Previous Clinical Trials
41,298,831 Total Patients Enrolled
5 Trials studying B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
763 Patients Enrolled for B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
Anjali S AdvaniPrincipal InvestigatorSouthwest Oncology Group
1 Previous Clinical Trials
39 Total Patients Enrolled

Eligibility Criteria

Age 65+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Patients with Philadelphia chromosome negative ALL or Ph chromosome positive ALL by cytogenetics, fluorescence in situ hybridization (FISH) or polymerase chain reaction (PCR) will be registered to receive treatment in either Cohort 1 (ph-) or Cohort 2 (Ph+ or Ph-like DSMKF) based on these results
Patients who have a lumbar puncture to determine CNS involvement of ALL within 14 days prior to registration will be excluded from the trial if they have CNS3 involvement
Patients must have a new morphologic diagnosis of precursor B cell acute lymphoblastic leukemia (ALL) (non T cell) based on World Health Organization (WHO) criteria; patients who have had a relapse of Burkitt's leukemia (L3) are excluded; patients with Ph-positive or Ph-like ALL with dasatinib-sensitive mutations or kinase fusions may have a relapsed or refractory diagnosis.
B Patients with relapsed or refractory leukemia who have positive Ph status, or who have dasatinib-sensitive mutations or kinase fusions, and have had previous exposure to dasatinib or another 2nd or 3rd generation tyrosine kinase inhibitor, will begin protocol therapy with a re-induction cycle 1.
: Patients in cohort I who have a bone marrow blast count of 50% or more blasts may be registered for treatment, but they should receive steroids for 3-5 days in order to reduce tumor burden prior to blinatumomab administration.
The patient must not have a history or presence of clinically relevant central nervous system (CNS) pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, active ALL in the CNS confirmed by cerebrospinal fluid (CSF) analysis, or other significant CNS abnormalities.
Patients with bone marrow blasts 50% or higher, peripheral blood blasts 15,000/uL or higher, or elevated LDH (>2.5 times upper limit of normal) are eligible for this study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 6th, 2021

Last Reviewed: October 19th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.