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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
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 belowSelect...
My kidney function, measured by creatinine levels, is within the normal range.
Select...
My cancer can be seen in my bone marrow or outside of it and can be measured and biopsied again.
Select...
My blood clotting time is normal or slightly above, unless I'm on blood thinners.
Select...
My heart pumps blood well.
Select...
My cancer did not respond to initial treatment or has come back after treatment.
Select...
I stopped all cancer treatments at least 1 week ago or waited for 5 half-lives of the treatment.
Select...
My blood clotting time is normal or slightly above, unless I'm on blood thinners.
Select...
My leukemia is CD19-positive B-cell ALL.
Select...
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:Select...
I do not have a severe illness that could affect my safety or how my body processes pembrolizumab.
Select...
I have been diagnosed with mature B-cell ALL or lymphoid blast crisis CML.
Select...
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
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 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Diarrhea
9%
Anemia
9%
Shortness of Breath
9%
Abdominal pain
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Weight Loss
7%
Dyspnea
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Atrial fibrillation with rapid ventricular response
4%
Pleural effusion
2%
colitis
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
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 2
~2070
Blinatumomab
2014
Completed Phase 3
~1230
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
596 Previous Clinical Trials
1,923,501 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,964 Total Patients Enrolled
Lihua BuddePrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials
29 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function, measured by creatinine levels, is within the normal range.My cancer can be seen in my bone marrow or outside of it and can be measured and biopsied again.My blood clotting time is normal or slightly above, unless I'm on blood thinners.I do not have a severe illness that could affect my safety or how my body processes pembrolizumab.My heart pumps blood well.I have been diagnosed with mature B-cell ALL or lymphoid blast crisis CML.I have a history of cancer that is not related to lymphoid tissue, with exceptions.I have had lung inflammation not caused by an infection.My cancer did not respond to initial treatment or has come back after treatment.I stopped all cancer treatments at least 1 week ago or waited for 5 half-lives of the treatment.I am on maintenance therapy medications.My blood clotting time is normal or slightly above, unless I'm on blood thinners.I have recently undergone chemotherapy, targeted therapy, or radiation.I have recently received a live vaccine.My leukemia is CD19-positive B-cell ALL.I received chemotherapy directly into my spinal canal no more than 7 days before starting pembrolizumab.My side effects from previous cancer treatments are mild or gone.I have stopped taking biologic medications for the required time.I have had a bone marrow transplant from another person.I am fully active or can carry out light work.I have had myelodysplastic syndrome or an organ transplant.I have been treated with specific medications before.I have a liver condition.I have active or symptomatic brain or spinal cord problems.I am on medication for an autoimmune disease.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pembrolizumab, blinatumomab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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