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BTK Inhibitor

Ibrutinib + Pembrolizumab for Leukemia and Lymphoma

Phase 1 & 2
Recruiting
Led By Joshua Brody, MD
Research Sponsored by Joshua Brody
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male subjects of childbearing potential must agree to use adequate contraception from the first dose of study therapy through 120 days after the last dose
Have a performance status of 0 or 1 on the ECOG Performance Scale
Must not have
Received prior anti-cancer monoclonal antibody within 4 weeks prior to study Day 1 or not recovered from adverse events
Received prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or not recovered from adverse events
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial will help determine the best dose of ibrutinib in combination with pembrolizumab for patients with CLL or MCL that has relapsed or progressed after prior therapy. The safety of this combination will also be studied.

Who is the study for?
Adults over 18 with chronic lymphocytic leukemia (CLL) or mantle cell lymphoma (MCL) who can provide consent and have measurable disease. They must be in good health otherwise, not pregnant, agree to use contraception, and haven't used certain other treatments recently like immunosuppressives or live vaccines.
What is being tested?
The trial is testing a combination of two drugs: Ibrutinib, which blocks an enzyme that helps blood cancer cells grow; and Pembrolizumab, an antibody designed to help the immune system fight tumor cells. This study aims to find the right dose and see if this experimental combo works for CLL/MCL.
What are the potential side effects?
Possible side effects include reactions related to the immune system attacking normal organs (autoimmune reactions), infusion-related reactions from receiving the drug into a vein, fatigue, infections due to lowered immunity, liver problems, and possibly others as it's an experimental treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a man who can father a child and will use birth control during and for 4 months after the study.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am 18 years old or older.
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My recent tests show my organs are functioning well.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had cancer treatment with antibodies in the last 4 weeks or still have side effects.
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I haven't had chemotherapy, targeted therapy, or radiation in the last 2 weeks.
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I have another cancer besides skin cancer that is getting worse or needs treatment.
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I have active brain metastases or cancer in the lining of my brain.
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I have a history of or currently have non-infectious lung inflammation.
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I am currently being treated for an infection.
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I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.
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My condition worsened despite being on a BTK inhibitor treatment.
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I have a history of HIV or active Hepatitis B or C.
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I have an immune system disorder or have been on steroids or immune-suppressing drugs recently.
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I have an active TB infection.
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I am not allergic to ibrutinib, pembrolizumab, or their ingredients.
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I have been treated for an autoimmune disease in the last year.

Timeline

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
Dose Limiting Toxicity (DLT)
Secondary study objectives
Complete Response (CR) rate
Overall Survival Rate
Progression-free Survival Rate

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
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Clostridium difficile colitis
1%
Systemic infection
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab + CRT Followed by Pembrolizumab
Placebo + CRT Followed by Placebo

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Participants with MCLExperimental Treatment2 Interventions
Participants with relapsed/ refractory Mantle Cell Lymphoma (MCL)
Group II: Participants with CLLExperimental Treatment2 Interventions
Participants with relapsed/ refractory Chronic Lymphocytic Leukemia (CLL) or 17p- CLL
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
FDA approved
Pembrolizumab
FDA approved

Find a Location

Who is running the clinical trial?

Joshua BrodyLead Sponsor
1 Previous Clinical Trials
21 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,012 Previous Clinical Trials
5,185,469 Total Patients Enrolled
Joshua Brody, MD5.03 ReviewsPrincipal Investigator - Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai
3 Previous Clinical Trials
83 Total Patients Enrolled

Media Library

Ibrutinib (BTK Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03153202 — Phase 1 & 2
Chronic Lymphocytic Leukemia Research Study Groups: Participants with MCL, Participants with CLL
Chronic Lymphocytic Leukemia Clinical Trial 2023: Ibrutinib Highlights & Side Effects. Trial Name: NCT03153202 — Phase 1 & 2
Ibrutinib (BTK Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03153202 — Phase 1 & 2
~3 spots leftby Dec 2025
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