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

Phase-Based Progress Estimates

Effectiveness

Safety

B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1+8 More

Blinatumomab - Biological

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Eligibility

65+

All Sexes

What conditions do you have?

Select

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

Blinatumomab

Venetoclax

Blinatumomab

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

Blinatumomab

Venetoclax

Blinatumomab

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 - 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.

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