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Monoclonal Antibodies
Pembrolizumab + Chemotherapy for B-Cell Lymphoma
Phase 2
Recruiting
Led By Justin Kline, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have measurable disease with one or more measurable lymphoma lesions (>1.5 cm in the long axis and >1.0 cm in the short axis).
Have adequate organ function. See below for adequate organ function laboratory values: Hematological: Absolute neutrophil count (ANC) less or equal to 1000/microliter, Platelets less or equal to 100,000/microliters, Hemoglobin less or equal to 8.0/grams per decilitre; Renal: Creatinine or Measured/calculated creatinine clearance (CrCl) greater or equal to 1.5xULN or less than or equal to 30 mililiter per minute for participants with creatinine levels less than 1.5xULN; Hepatic: Total bilirubin greater than or equal to 1.5 x ULN or direct bilirubin greater than or equal to ULN for participants with total bilirubin levels less than 1.5 x ULN, AST (SGOT) and ALT (SGPT) greater than or equal to 2.5 x ULN (greater than or equal to 2.5 x ULN for participants with liver involvement)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 29 months
Awards & highlights
Study Summary
This trial will research a new chemotherapy treatment for lymphoma and what causes the disease.
Who is the study for?
Adults with untreated non-germinal center diffuse large B cell lymphoma or high-grade B cell lymphoma, not pregnant or breastfeeding, willing to use contraception. Must have measurable disease and adequate organ function. Cannot have had prior anti-lymphoma therapy or certain other treatments, no active infections like HIV or hepatitis, and no history of severe hypersensitivity to trial drugs.Check my eligibility
What is being tested?
The study is testing the effectiveness of pembrolizumab combined with R-CHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) in treating patients with specific types of B cell lymphoma that haven't been treated before.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as inflammation in various organs including lungs (pneumonitis), infusion-related reactions from the drug administration process itself; fatigue; blood disorders; increased risk for infections due to immune suppression.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a lymphoma lesion larger than 1.5 cm long and 1.0 cm wide.
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My blood, kidney, and liver tests meet the required levels.
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I am 18 or older with a confirmed diagnosis of a specific type of lymphoma.
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I have a lymphoma lesion larger than 1.5 cm long and 1.0 cm wide.
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My cancer's risk score is high based on the IPI or aaIPI.
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I can provide a sample of my tumor for testing.
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My organ functions are within normal ranges.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My kidney function, measured by creatinine clearance, is within the required range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 29 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~29 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression free survival (PFS) rate when combining pembrolizumab with R-CHOP
Secondary outcome measures
Complete response (CR) rate after 6 cycles of pembrolizumab in combination with R-CHOP
Event free survival (EFS) rate after 6 cycles of pembrolizumab in combination with R-CHOP
Number of participants with treatment related adverse events as assessed by CTCAE v 4.0
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,055,032 Total Patients Enrolled
University of ChicagoLead Sponsor
1,004 Previous Clinical Trials
819,740 Total Patients Enrolled
Justin Kline, MDPrincipal InvestigatorUniversity of Chicago Medicine
2 Previous Clinical Trials
39 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have previously undergone treatment for lymphoma.I have a history of Hepatitis B or an active Hepatitis C infection.I have a lymphoma lesion larger than 1.5 cm long and 1.0 cm wide.I agree to use contraception and not donate sperm for 120 days after my last treatment dose.I have another cancer besides skin or in situ cancers that needed treatment in the last 2 years.I am currently being treated for an infection.I have fully recovered from any major surgery before starting the study treatment.My blood, kidney, and liver tests meet the required levels.I have been treated with specific immune therapy drugs before.I have a heart condition with an ejection fraction below 45%, recent heart attack, severe heart failure, or uncontrolled heart issues.I am 18 or older with a confirmed diagnosis of a specific type of lymphoma.I have a specific type of lymphoma diagnosed as high-grade, primary mediastinal, gray zone, composite, or transformed low-grade to DLBCL.I am not pregnant or breastfeeding and either cannot become pregnant or agree to use birth control.I have a lymphoma lesion larger than 1.5 cm long and 1.0 cm wide.My cancer's risk score is high based on the IPI or aaIPI.I can provide a sample of my tumor for testing.I have been diagnosed with HIV.I have an autoimmune disease treated with strong medication in the last 2 years.My organ functions are within normal ranges.I have not received a live vaccine in the last 30 days.I am not on high-dose steroids or other drugs that weaken my immune system.I am fully active or restricted in physically strenuous activity but can do light work.I have had an organ transplant.I have taken corticosteroids for less than 10 days to ease my lymphoma symptoms.My kidney function, measured by creatinine clearance, is within the required range.I have or had tuberculosis.My lymphoma has spread to my brain or spinal cord.I have had or currently have lung inflammation treated with steroids.I am not pregnant, not breastfeeding, and meet one of the required conditions.My kidney function is normal.My liver is functioning properly.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm
Awards:
This trial has 3 awards, including:- Approved for 30 Other Conditions - This treatment demonstrated efficacy for 30 other conditions.
- 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.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what conditions is the R-CHOP Protocol usually applied?
"As the go-to treatment for metastatic cutaneous squamous cell carcinoma, R-CHOP Protocol has also been demonstrated to manage relapsing polychondritis, melanoma, and malignant melanomas of skin."
Answered by AI
What is the maximum number of participants this clinical trial can accommodate?
"Affirmative. Clinicaltrials.gov records demonstrate that this clinical trial, which was initially posted on August 29th 2019, is currently recruiting patients. A total of 51 individuals need to be enlisted from a solitary site for the study's completion."
Answered by AI
To what extent can taking R-CHOP Protocol be hazardous to health?
"Our team's assessment of R-CHOP Protocol yielded a 2 rating due to the limited amount of evidence supporting its safety but lack thereof when it comes to efficacy."
Answered by AI
Are there any available slots for participation in this experiment?
"Confirmed. The clinical trial is actively searching for eligible participants, as sourced from the information found on clinicaltrials.gov. It was initially posted in August of 2019 and has been altered most recently on January 5th 2021; 51 individuals are being recruited at one location."
Answered by AI
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