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Monoclonal Antibodies

Blinatumomab for Acute Lymphoblastic Leukemia

Phase 2

Waitlist Available

Led By Elias Jabbour

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with B-lineage acute lymphocytic leukemia (ALL) in hematologic complete remission (CR) with molecular failure or molecular relapse starting at any time point after 3 months of frontline therapy; molecular disease or minimal residual disease is defined by a value of at least of 1 x 10^-4 (0.01%) by multicolor flow cytometry and/or by next generation sequencing (NGS)

Performance status of 0, 1, or 2

Must not have

Unable or unwilling to sign the consent form

Active central nervous system (CNS) or extramedullary disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at how well blinatumomab works in treating patients with leukemia whose disease is in remission but is still present in a small number of cells in the body.

Who is the study for?

This trial is for adults with B-cell acute lymphoblastic leukemia in remission but still have minimal residual disease. Eligible participants must be relatively healthy (performance status 0-2), may have Philadelphia chromosome positive ALL, and should not have other active cancers or life expectancy under 12 months. Pregnant women, HIV+ individuals, those with uncontrolled diseases/infections, or CNS involvement are excluded.

What is being tested?

The study tests blinatumomab's effectiveness on patients whose leukemia is in remission but detectable at low levels. It's a phase II trial to see if this monoclonal antibody can prevent the growth and spread of remaining cancer cells by activating the immune system.

What are the potential side effects?

Blinatumomab might cause side effects like allergic reactions, fever, headache, fatigue, nausea and increased risk of infections due to its impact on the immune system. The exact side effects will vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My leukemia is in remission but still shows signs of disease on a molecular level.

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I can take care of myself and perform daily activities.

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I do not have another cancer that could shorten my life within a year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot or do not want to sign the consent form.

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My cancer has spread to my brain or is affecting areas outside my bone marrow.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Relapse-free survival (RFS)

Secondary study objectives

Event-free survival

Incidence of toxicity

MRD negativity rate

+2 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%

Pruritus

11%

Erythema

11%

Hypokalaemia

11%

Hypogammaglobulinaemia

11%

Hypotension

Tremor

Neutropenia

Epistaxis

Constipation

Neutrophil count decreased

Immunodeficiency

White blood cell count decreased

Agitation

Alanine aminotransferase increased

Hypervolaemia

Anal inflammation

Cough

Thrombocytopenia

Abdominal pain upper

Petechiae

Fluid overload

Paronychia

Rash maculo-papular

Back pain

Fatigue

Decreased appetite

Nasopharyngitis

Febrile neutropenia

Urticaria

Fluid balance positive

Seizure

Oropharyngeal pain

Aplasia

Pain in extremity

Neurological symptom

Aspartate aminotransferase increased

Nervous system disorder

Oral pain

Perineal cellulitis

Haematoma

Herpes virus infection

Klebsiella infection

Engraftment syndrome

Blood immunoglobulin G decreased

Complication associated with device

Accidental overdose

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.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (blinatumomab)Experimental Treatment2 Interventions

Patients receive blinatumomab IV continuously on days 1-28. Treatment repeats every 6 weeks for up to 5 courses in the absence of disease progression or unacceptable toxicity. Patients who do not proceed with stem cell transplantation may receive blinatumomab IV maintenance therapy with one cycle every 3 months for up to 4 cycles. Patients who remain in MRD remission for 3 months and then become MRD positive again can be retreated following the same treatment plan previously received.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Blinatumomab

2014

Completed Phase 3

~1230

0 / 5Eligibility criteria met