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Bi-specific T-cell Engager (BiTE)

Blinatumomab for Acute Lymphoblastic Leukemia

Phase 1 & 2

Recruiting

Research Sponsored by Amgen

Eligibility Criteria Checklist

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

Must have

Aged 18 years or older

- In untreated first, second, third or greater relapse or refractory relapse

Must not have

- Active ALL in the central nervous system (CNS). Presence of greater than 5 white blood cells per cubic millimeter in cerebrospinal fluid (CSF) with lymphoblasts present and/or clinical signs of CNS leukemia

- Allogeneic HSCT within 12 weeks before the start of protocol-specified therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the safety and effectiveness of a new cancer drug for people with a certain type of leukemia.

Who is the study for?

This trial is for adults with B-precursor Acute Lymphoblastic Leukemia (ALL) who may have relapsed after stem cell transplant, have a certain percentage of cancer cells in their bone marrow, or are not responding to other treatments. It's open to those with an ECOG Performance Status of 2 or less and includes patients intolerant to tyrosine kinase inhibitors.

What is being tested?

The study tests the safety and effectiveness of Blinatumomab given under the skin for treating ALL. It aims to find the highest dose patients can tolerate without severe side effects and establish recommended doses for future phases. The trial also examines how the body processes this drug.

What are the potential side effects?

Blinatumomab can cause side effects like allergic reactions at the injection site, fever, headache, nausea, fatigue, and infections. Some people might experience neurological issues such as seizures or confusion.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My condition is in its first or later relapse and has not been treated yet.

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My disease did not fully respond to the initial treatment.

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My B Cell ALL Ph+ disease has not responded to previous TKI treatments.

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My cancer did not fully respond to the last treatment I received.

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My condition did not improve after receiving secondary treatment.

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My condition relapsed after a stem cell transplant.

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I can take care of myself and am up and about more than half of my waking hours.

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My condition worsened or didn't improve after my first follow-up treatment.

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My cancer did not respond to initial treatment or to at least one follow-up treatment.

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My cancer has returned after my second complete remission.

Exclusion Criteria

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

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I have leukemia in my brain or spinal cord.

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I had a stem cell transplant from a donor within the last 12 weeks.

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I have no history of major brain-related health issues like epilepsy, stroke, or dementia.

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I plan to breastfeed during and shortly after treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Ph-IIC: Clinical PK Evaluation of SC Blinatumomab FormulationsExperimental Treatment1 Intervention

1 cohort of participants will be enrolled into the Ph-IIC arm. The clinical PK evaluation cohort (Ph-IIC) will be conducted to compare the PK of SC1 and SC2 formulations at the RP2D determined from the dose expansion phase, in participants with R/R B-ALL.

Group II: Dose Expansion Phase: Blinatumomab SC1Experimental Treatment1 Intervention

Up to 4 cohorts of participants with R/R B-ALL will be enrolled to the preliminary recommended phase 2 dose (RP2D) and schedule determined from dose escalation phase. Each cohort will aim to further assess safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy.

Group III: Dose Escalation Phase: Blinatumomab Subcutaneous Formulation 1 (SC1)Experimental Treatment1 Intervention

Cohorts of at least 3 participants each will be treated with escalating doses of bilinatumomab to determine the maximum tolerated dose (MTD). The MTD will be defined as the dose for which the estimate of the toxicity rate from an isotonic regression (Yan et al, 2017) is closest to the target toxicity rate. Safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy will be assessed.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Blinatumomab

2014

Completed Phase 3

~1230

0 / 15Eligibility criteria met