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Bi-specific T-Cell Engager

Blinatumomab + Chemotherapy for Leukemia

Brighton, MI
Phase 3
Recruiting
Led By Yishai Ofran
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who presented with acute organ dysfunction must have AST (SGOT)/ALT (SGPT) =< 2 X institutional upper limit of normal (ULN)
Patients with a history of hepatitis C virus (HCV) infection must have an undetectable HCV viral load and if indicated, on treatment
Must not have
Patient must not have unstable epilepsy that requires treatment
Patients with lymphoid blast crisis CML are not eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from randomization to failure to achieve induction molecular remission by week 15, confirmed molecular relapse after molecular remission or to death in remission, assessed up to 10 years from the date of registration
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing if adding the drug blinatumomab to the usual chemotherapy and steroids treatment for acute lymphoblastic leukemia (ALL) is more effective than the standard of care.

See full description
Who is the study for?
Adults aged 18-75 with newly diagnosed BCR-ABL-positive acute lymphoblastic leukemia (ALL) can join this trial. They should be in decent physical shape, not pregnant or breastfeeding, and willing to use contraception. People with active brain involvement by leukemia, unstable epilepsy, other cancers, or those who have already started certain treatments for ALL are excluded.Check my eligibility
What is being tested?
The study is testing if adding blinatumomab—a cancer cell growth inhibitor—to the usual treatment of chemotherapy, steroids, and a tyrosine kinase inhibitor is more effective for treating ALL. It's a phase III trial where patients receive either standard care or standard care plus blinatumomab.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system such as inflammation in various organs; blood disorders; fatigue; digestive issues like nausea and vomiting; increased risk of infections due to lowered immunity; and potential heart problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My liver enzymes are within twice the normal limit.
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I had hepatitis C but now have an undetectable viral load, and I'm on treatment if needed.
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I can care for myself but may not be able to do heavy physical work.
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My condition is BCR-ABL1 positive.
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My leukemia is Philadelphia chromosome positive, confirmed by a central lab.
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My hepatitis B is under control or being treated effectively.
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My bilirubin levels are within twice the normal limit, despite recent acute organ issues.
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My bilirubin levels are within twice the normal limit, and I had recent acute organ dysfunction.
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I am between 18 and 75 years old.
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My kidneys work well enough (creatinine clearance > 45 mL/min).
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I have been recently diagnosed with B-ALL or it is suspected.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My epilepsy is stable and does not need treatment.
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I do not have lymphoid blast crisis CML.
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I do not have BCR/ABL T-ALL.
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I have not received chemotherapy for B-ALL.
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I do not have any other active cancer.
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My leukemia has not spread to my brain or spinal cord.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from randomization to failure to achieve induction molecular remission by week 15, confirmed molecular relapse after molecular remission or to death in remission, assessed up to 10 years from the date of registration
This trial's timeline: 3 weeks for screening, Varies for treatment, and time from randomization to failure to achieve induction molecular remission by week 15, confirmed molecular relapse after molecular remission or to death in remission, assessed up to 10 years from the date of registration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall survival (OS)
Secondary study objectives
Event free survival (EFS)
Incidence of adverse events
Rate of MRD negativity
+1 more

Side effects data

From 2022 Phase 3 trial • 111 Patients • NCT02393859
52%
Stomatitis
46%
Anaemia
25%
Neutropenia
21%
Thrombocytopenia
21%
Abdominal pain
21%
Vomiting
19%
Pyrexia
17%
Febrile neutropenia
17%
Nausea
17%
Diarrhoea
15%
Platelet count decreased
15%
Headache
13%
Constipation
13%
Alanine aminotransferase increased
13%
Epistaxis
10%
Rhinitis
10%
Aspartate aminotransferase increased
10%
Hypokalaemia
10%
Back pain
10%
Pain in extremity
10%
Pruritus
10%
Rash
8%
Aplasia
8%
Abdominal pain upper
8%
Mucosal inflammation
8%
Hypertransaminasaemia
8%
Arthralgia
8%
Hypertension
8%
Hypotension
6%
Leukopenia
6%
Oral pain
6%
Antithrombin III decreased
6%
Fluid balance positive
6%
Oropharyngeal pain
6%
Haematoma
6%
Pain
6%
Hepatotoxicity
4%
Fatigue
4%
Hypogammaglobulinaemia
4%
Erythema
4%
Anal inflammation
4%
Neutrophil count decreased
2%
Pancreatitis acute
2%
Bronchitis
2%
Clostridium difficile colitis
2%
Device related infection
2%
Escherichia bacteraemia
2%
Septic shock
2%
Pneumothorax traumatic
2%
Lipase increased
2%
Capillary leak syndrome
2%
Staphylococcal infection
2%
Viral infection
2%
Vulvitis
2%
B precursor type acute leukaemia
2%
Nasopharyngitis
2%
White blood cell count decreased
2%
Decreased appetite
2%
Agitation
2%
Cough
2%
Petechiae
2%
Acute lymphocytic leukaemia recurrent
100%
80%
60%
40%
20%
0%
Study treatment Arm
HC3 Chemotherapy
Blinatumomab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Arm E (steroid, TKI, chemotherapy)Experimental Treatment14 Interventions
Patients treated on Arm C who remain MRD positive at the end of induction therapy receive chemotherapy based re-induction which is identical to regimen described for Arm B according to patient's age and the pre-specified chemotherapy arm. Patients whose molecular test remains MRD positive after re-induction proceed to follow-up at the discretion of the investigator or receive anti CD-19 CAR- T cell therapy, inotuzumab ozogamicin, intensive chemotherapy, or palliative care.
Group II: Arm D (steroid, TKI, chemotherapy, immunotherapy)Experimental Treatment12 Interventions
Patients treated on Arm B who remain MRD positive at the end of induction therapy receive blinatumomab based re-induction identical to the regimen described for Arm C. Patients whose molecular test remains MRD positive after re-induction proceed to follow-up at the discretion of the investigator or receive anti CD-19 CAR- T cell therapy, inotuzumab ozogamicin, intensive chemotherapy, or palliative care.
Group III: Arm C (steroid, TKI, chemotherapy, immunotherapy)Experimental Treatment12 Interventions
CYCLE 1: Patients receive ponatinib PO QD or dasatinib PO QD on days 1-28. Patients also receive dexamethasone PO or IV on day 1 and blinatumomab IV continuously on days 1-28, followed by methotrexate IT on day 29 or 30. CYCLE 2: Patients receive ponatinib PO QD or dasatinib PO QD on days 1-28. Patients also receive dexamethasone PO or IV on day 1 and blinatumomab IV continuously on days 1-28. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
Group IV: Arm B (steroid, TKI, chemotherapy)Experimental Treatment15 Interventions
See Detailed Description.
Group V: Arm A (steroid, TKI), Single Arm Pre-InductionActive Control9 Interventions
Patients receive prednisone PO QD on days 1-21 and ponatinib PO QD or dasatinib PO QD on days 1-21 based on investigator's choice.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Electrocardiography
2014
N/A
~220
Biospecimen Collection
2004
Completed Phase 3
~1810
Blinatumomab
2020
Completed Phase 3
~1210
Bone Marrow Aspiration and Biopsy
2016
Completed Phase 1
~40
Lumbar Puncture
2016
Completed Phase 3
~540
Multigated Acquisition Scan
2017
Completed Phase 3
~350
Cyclophosphamide
2010
Completed Phase 4
~2280
Cytarabine
2016
Completed Phase 3
~4020
Dexamethasone
2007
Completed Phase 4
~2650
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17860
Vincristine Sulfate
2004
Completed Phase 3
~10650
Dasatinib
2012
Completed Phase 3
~2290
Echocardiography
2013
Completed Phase 4
~11580
Ponatinib Hydrochloride
2014
Completed Phase 2
~30
Mesna
2003
Completed Phase 2
~1430
Methotrexate
2019
Completed Phase 4
~4400

Find a Location

Closest Location:University of Oklahoma Health Sciences Center· Oklahoma City, OK· 159 miles

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
14,057 Previous Clinical Trials
41,149,085 Total Patients Enrolled
Yishai OfranPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Media Library

Blinatumomab (Bi-specific T-Cell Engager) Clinical Trial Eligibility Overview. Trial Name: NCT04530565 — Phase 3
Chronic Myeloid Leukemia Research Study Groups: Arm E (steroid, TKI, chemotherapy), Arm A (steroid, TKI), Single Arm Pre-Induction, Arm B (steroid, TKI, chemotherapy), Arm C (steroid, TKI, chemotherapy, immunotherapy), Arm D (steroid, TKI, chemotherapy, immunotherapy)
Chronic Myeloid Leukemia Clinical Trial 2023: Blinatumomab Highlights & Side Effects. Trial Name: NCT04530565 — Phase 3
Blinatumomab (Bi-specific T-Cell Engager) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04530565 — Phase 3
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