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Bi-specific T-Cell Engager

Blinatumomab + Chemotherapy for Leukemia

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.

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.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

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

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

80%

Pyrexia

43%

Nausea

37%

Headache

31%

Vomiting

24%

Anaemia

22%

Diarrhoea

20%

Stomatitis

17%

Mucosal inflammation

13%

Abdominal pain

13%

Platelet count decreased

13%

Rash

13%

Hypertension

11%

Erythema

11%

Pruritus

11%

Hypokalaemia

11%

Hypogammaglobulinaemia

11%

Hypotension

Neutropenia

Epistaxis

Tremor

Constipation

Neutrophil count decreased

White blood cell count decreased

Alanine aminotransferase increased

Immunodeficiency

Agitation

Hypervolaemia

Anal inflammation

Cough

Thrombocytopenia

Abdominal pain upper

Petechiae

Fluid overload

Back pain

Rash maculo-papular

Paronychia

Decreased appetite

Fatigue

Nasopharyngitis

Febrile neutropenia

Urticaria

Fluid balance positive

Seizure

Oropharyngeal pain

Aplasia

Pain in extremity

Neurological symptom

Aspartate aminotransferase increased

Oral pain

Engraftment syndrome

Herpes virus infection

Blood immunoglobulin G decreased

Complication associated with device

Nervous system disorder

Klebsiella infection

Perineal cellulitis

Accidental overdose

Haematoma

Neurological examination abnormal

Catheter placement

Antithrombin III decreased

Laryngotracheitis obstructive

Pain

Hypertransaminasaemia

Rhinitis

Body temperature increased

100%

80%

60%

40%

20%

Study treatment Arm

Blinatumomab

HC3 Chemotherapy

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