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Monoclonal Antibodies

Pembrolizumab + Blinatumomab for Acute Lymphoblastic Leukemia

Phase 1 & 2

Recruiting

Led By Lihua Budde

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

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

Must have

Serum creatinine =< 1.5 X upper limit of normal or measured or calculated creatinine clearance >= 60 ml/min for subjects with creatinine levels > 1.5 X institutional ULN

Subjects with detectable lymphoblasts in bone marrow or extramedullary disease that is radiographically measurable and amenable to repeat biopsies

Must not have

Life-threatening illness or medical condition that could compromise safety or interfere with pembrolizumab metabolism

Diagnosis of mature B-cell ALL or lymphoid blast crisis of CML

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the side effects and effectiveness of two cancer drugs, pembrolizumab and blinatumomab, in treating patients with acute lymphoblastic leukemia that has returned or is resistant to treatment.

Who is the study for?

This trial is for people with acute lymphoblastic leukemia that's come back or didn't respond to treatment. They must have had prior treatments, be relatively healthy and active (ECOG status 0-1), have good heart and lung function, normal kidney and liver tests, not pregnant or breastfeeding, no HIV/HBV/HCV infections, and willing to use contraception.

What is being tested?

The study is testing the effectiveness of two monoclonal antibodies—pembrolizumab and blinatumomab—in treating recurrent or unresponsive acute lymphoblastic leukemia. It aims to see how these drugs affect tumor growth.

What are the potential side effects?

Possible side effects include allergic reactions to the drugs, potential organ inflammation due to immune response changes caused by pembrolizumab and blinatumomab, fatigue from treatment-related stress on the body, as well as increased risk of infection.

Eligibility Criteria

Inclusion Criteria

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

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My kidney function, measured by creatinine levels, is within the normal range.

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My cancer can be seen in my bone marrow or outside of it and can be measured and biopsied again.

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My blood clotting time is normal or slightly above, unless I'm on blood thinners.

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My heart pumps blood well.

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My cancer did not respond to initial treatment or has come back after treatment.

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I stopped all cancer treatments at least 1 week ago or waited for 5 half-lives of the treatment.

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My blood clotting time is normal or slightly above, unless I'm on blood thinners.

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My leukemia is CD19-positive B-cell ALL.

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I am fully active or can carry out light work.

Exclusion Criteria

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

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I do not have a severe illness that could affect my safety or how my body processes pembrolizumab.

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I have been diagnosed with mature B-cell ALL or lymphoid blast crisis CML.

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I have a history of cancer that is not related to lymphoid tissue, with exceptions.

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I have had lung inflammation not caused by an infection.

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I have recently received a live vaccine.

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I have had a bone marrow transplant from another person.

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I have had myelodysplastic syndrome or an organ transplant.

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I have been treated with specific medications before.

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I have active or symptomatic brain or spinal cord problems.

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I am on medication for an autoimmune disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of toxicity (Phase 1)

Response (Phase 2)

Secondary study objectives

Allogeneic stem cell transplantation (SCT) realization rate

Event-free survival

Incidence of adverse events

+3 more

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Systemic infection

Clostridium difficile colitis

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Pembrolizumab + CRT Followed by Pembrolizumab

Placebo + CRT Followed by Placebo

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 (pembrolizumab, blinatumomab)Experimental Treatment3 Interventions

Participants receive pembrolizumab IV over 30 minutes on day 15 of course 1 and days 1 and 22 of courses 2 -4, and blinatumomab IV on days 1-28. Treatment repeats every 35-42 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

Blinatumomab

2014

Completed Phase 3

~1230