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Monoclonal Antibodies
Combination Immunotherapy + Chemotherapy for Lymphoma
Phase 1
Waitlist Available
Led By Liana Nikolaenko
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is studying avelumab, utomilumab, rituximab, ibrutinib, and combination chemotherapy to treat patients with diffuse large B-cell lymphoma or mantle cell lymphoma that has come back or does not respond to treatment.
Who is the study for?
This trial is for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or mantle cell lymphoma (MCL). They must have a life expectancy over 3 months, be in fairly good health (ECOG score of 0-2), and have adequate organ function. Women should not be pregnant and both genders must agree to use contraception. Exclusions include prior treatments with certain drugs, active infections, other cancers within the last 3 years, severe heart conditions, CNS disease history, and autoimmune diseases.Check my eligibility
What is being tested?
The trial tests the combination of monoclonal antibodies avelumab, utomilumab, rituximab with chemotherapy agents ifosfamide, carboplatin etoposide phosphate plus Ibrutinib in patients who've had their lymphoma return or resist treatment. It aims to find safe dosages and observe how well these drugs work together against these types of cancer.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system such as inflammation in various organs; infusion-related reactions; blood disorders that can affect clotting or lead to anemia; fatigue; digestive issues like nausea or diarrhea; increased risk of infection due to weakened immunity.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Maximum tolerated dose determined by dose-limiting toxicities
Secondary outcome measures
CR rate
Duration of response
Overall response rate
+1 moreOther outcome measures
Immunologic and genomic biomarkers
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort II (avelumab, utomilumab, rituximab, ibrutinib)Experimental Treatment5 Interventions
Patients receive rituximab IV on day 1, avelumab IV over 60 minutes on days 2 and 16, and ibrutinib PO QD or rituximab IV on day 1, avelumab IV over 60 minutes on days 2 and 16, utomilumab IV on day 2, and ibrutinib PO QD. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. (Closed as of 12/12/2019)
Group II: Cohort I (avelumab, utomilumab, RICE)Experimental Treatment8 Interventions
Patients receive rituximab IV on day 1, etoposide phosphate IV on days 1-3, avelumab IV over 60 minutes on day 2, ifosfamide IV over 24 hours on day 2, and carboplatin IV on day 2 or rituximab IV on day 1, etoposide phosphate IV on days 1-3, avelumab IV over 60 minutes on days 2, utomilumab IV over 60 minutes on day 2, ifosfamide IV over 24 hours on day 2, and carboplatin IV on day 2. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients may then undergo autologous hematopoietic stem cell transplantation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
2014
Completed Phase 3
~1880
Ifosfamide
2010
Completed Phase 4
~2980
Avelumab
2018
Completed Phase 2
~2450
Carboplatin
2014
Completed Phase 3
~6670
Etoposide Phosphate
2011
Completed Phase 2
~160
Autologous Hematopoietic Stem Cell Transplantation
2017
Completed Phase 3
~1730
Rituximab
1999
Completed Phase 4
~1880
Utomilumab
2018
Completed Phase 2
~30
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,444 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,651 Total Patients Enrolled
Liana NikolaenkoPrincipal InvestigatorCity of Hope Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are physically able to perform daily activities without any significant limitation (ECOG performance score of 0-2).You must agree in writing to participate in this study and understand that you can change your mind and stop participating at any time without it affecting your future medical care.You have undergone at least one treatment in the past, but it did not work or your condition has worsened since then.You are expected to live for at least 3 more months.You have been treated with a drug that targets PD-1 or PD-L1 before.You have a serious heart condition that is currently active.You have a specific type of lymphoma called DLBCL that has not responded to previous treatment. This also includes patients with DLBCL that started as a different type of lymphoma.You have already tried and failed to respond to one or two different treatments for your condition.You must have a tumor that is at least 1.5 cm in size, which can be seen on a CT scan or PET scan of your neck, chest, abdomen, or pelvis.You are able to receive high-dose chemotherapy followed by autologous stem cell transplant.If you had an organ transplant, including a stem-cell transplant, you cannot participate in cohort 1 (DLBCL).You are currently taking medication that weakens your immune system, except in certain situations.Your screening ECG has significant abnormalities, which could affect your eligibility to participate in Cohort #2 (MCL).You or your legal guardians must be able to read and sign a document saying that you understand and agree to participate in the study.You weigh more than 40 kilograms (about 88 pounds).You have a type of cancer called Mantle Cell Lymphoma that has come back after treatment or has not responded to treatment. Your diagnosis needs to be confirmed by a biopsy test that shows the presence of a protein called cyclin D1.You have a medical condition that is very serious and could be life-threatening.You have an autoimmune disease that could get worse if you take a medicine that boosts your immune system.You have serious ongoing medical conditions, such as immune colitis, inflammatory bowel disease, or pulmonary fibrosis. You have also experienced serious psychiatric issues, including suicidal thoughts or actions in the past year.You were diagnosed with or treated for another type of cancer within the past 3 years, except for certain types of skin or prostate cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort II (avelumab, utomilumab, rituximab, ibrutinib)
- Group 2: Cohort I (avelumab, utomilumab, RICE)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the FDA sanction Autologous Hematopoietic Stem Cell Transplantation?
"Autologous Hematopoietic Stem Cell Transplantation has limited evidence of safety and efficacy, so it receives a score of 1."
Answered by AI
Is there still availability in this research project for participants?
"The research hosted on clinicaltrials.gov indicates that this investigation is no longer enrolling participants, with the study first being posted in April 2018 and last updated during July 2022. Thankfully, there are over 4 thousand six hundred seventy eight other trials recruiting right now."
Answered by AI
Has any research been conducted about Autologous Hematopoietic Stem Cell Transplantation in the past?
"Presently, 449 clinical trials concerning Autologous Hematopoietic Stem Cell Transplantation are in Phase 3 and 2015 studies remain active. The majority of these experiments originate from Provincia di Ascoli Piceno though there are currently 85386 centres hosting relevant research."
Answered by AI
How many participants are currently involved in this trial?
"This research has wrapped up its recruitment phase, with the first post being made on April 2nd 2018 and the last update occurring on July 31st 2022. For those looking to take part in a clinical trial related to lymphoma, large b-cell diffuse there are currently 2663 trials actively recruiting while 2015 studies require participants for Autologous Hematopoietic Stem Cell Transplantation investigations."
Answered by AI
What is the primary aim of this experiment?
"This two-year clinical trial seeks to determine the maximum tolerated dosage of a drug by analysing dose-limiting toxicities. Secondary outcomes include ascertaining the complete response rate through assessing evaluable patients, overall response rate based on those achieving either CR or PR, and duration of response from achievement to relapse/progression with Kaplan-Meier product limit method and Greenwood estimator."
Answered by AI
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