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BiTE Antibody

Blinatumomab for Acute Lymphoblastic Leukemia

Phase 3

Waitlist Available

Led By Patrick A Brown

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

No prior treatment with blinatumomab

Performance status corresponding to ECOG scores of 0, 1, or 2

Must not have

Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia

Patients with B-lymphoblastic lymphoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial compares blinatumomab with standard chemotherapy in treating relapsed B-cell acute lymphoblastic leukemia.

Who is the study for?

This trial is for young patients under 31 years old with a first relapse of B-cell acute lymphoblastic leukemia. They must not have had prior stem cell transplants or blinatumomab treatment, and their major organs need to function well. Patients with HIV, pregnant or breastfeeding women, and those with certain genetic syndromes or significant CNS pathology are excluded.

What is being tested?

The trial is testing the effectiveness of blinatumomab (an immunotherapy) against standard combination chemotherapy in treating relapsed B-cell acute lymphoblastic leukemia. It aims to see if blinatumomab can better engage the immune system to attack leukemia cells compared to traditional treatments.

What are the potential side effects?

Blinatumomab may cause side effects like allergic reactions, fever, headache, nausea, fatigue, and an increased risk of infections. Chemotherapy can lead to hair loss, mouth sores, low blood cell counts increasing infection risk and bleeding problems.

Eligibility Criteria

Inclusion Criteria

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

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I have never been treated with blinatumomab.

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I can take care of myself but may not be able to do heavy physical work.

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My heart is functioning within normal limits.

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My kidney function is appropriate for my age and gender.

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My B-ALL cancer has returned for the first time.

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I am between 1 and 30 years old and my cancer has returned.

Exclusion Criteria

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

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I have Burkitt leukemia/lymphoma or mature B-cell leukemia.

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I have B-lymphoblastic lymphoma.

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I have T-lymphoblastic leukemia/lymphoma.

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My leukemia is Philadelphia chromosome positive.

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I have a serious brain or spinal cord condition.

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My cancer has spread to my optic nerve or retina.

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I am sexually active and not using birth control.

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I have a diagnosed genetic syndrome.

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I have seizures that are not controlled by medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Disease Free Survival (DFS) of High-risk (HR) and Intermediate-risk (IR) Relapse Patients

Disease Free Survival (DFS) of Low Risk (LR) Relapse Patients

Secondary study objectives

Overall Survival (OS) of HR and IR Relapse Patients

Overall Survival (OS) of LR Relapse Patients

Other study objectives

Blinatumomab Pharmacokinetics (PK)

Feasibility of Rapid Taper of Immune Suppression for Subset of HSCT Patients With MRD >= 0.01% Pre- and/or Post-HSCT With no Acute Graft Versus Host Disease (aGVHD)

Hematologic Complete Remission Rate (for Treatment Failure Patients Not Previously Receiving Blinatumomab)

+4 more

Side effects data

From 2019 Phase 2 trial • 77 Patients • NCT01251575

Hypoxia

Febrile neutropenia

Acute kidney injury

Blood bilirubin increased

Diarrhea

Creatinine increased

Sepsis

Hypotension

Left ventricular systolic dysfunction

Bronchopulmonary hemorrhage

Chronic kidney disease

Thromboembolic event

Lung infection

Atrial fibrillation

Atrial flutter

Hemolysis

Hemolytic uremic syndrome

Ejection fraction decreased

Encephalitis infection

Gastric hemorrhage

Gastritis

Heart failure

Mucositis oral

Multi-organ failure

Myalgia

Pleural effusion

Respiratory failure

Small intestine infection

Syncope

Treatment related secondary malignancy

Typhlitis

Fever

Paroxysmal atrial tachycardia

Ascites

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Fludarabine, Transplant, Immunosuppression)

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Arm D (LR blinatumomab)Experimental Treatment15 Interventions

Patients receive Block 2 over 4 weeks, Blinatumomab Cycle 1 over 5 weeks, Continuation 1 over 8 weeks, Blinatumomab Cycle 2 over 5 weeks, Continuation 2 over 8 weeks, Blinatumomab Cycle 3 over 5 weeks, and then Maintenance.

Group II: Arm B (HR and IR blinatumomab)Experimental Treatment7 Interventions

Patients receive Blinatumomab Block 1 over 5 weeks, Blinatumomab Block 2 over 5 weeks, and then undergo allogeneic HSCT.

Group III: Arm C (LR control)Active Control15 Interventions

Patients receive Block 2 over 4 weeks, Block 3 over 4 weeks, Continuation 1 over 8 weeks, Continuation 2 over 8 weeks, and then Maintenance.

Group IV: Arm A (HR and IR control)Active Control15 Interventions

Patients receive Block 2 over 4 weeks, Block 3 over 4 weeks, and then undergo allogeneic HSCT. Closed effective September 18, 2019.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007