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Daratumumab + Chemotherapy for Lymphoma
Study Summary
This trial is studying how well daratumumab in combination with standard chemotherapy works in treating patients with newly diagnosed stage I-IV plasmablastic lymphoma.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- My cancer is at an advanced stage or early stage with high LDH/bulky tumor.You will need to take an HIV test that is confirmed by a second test to make sure you do not have HIV.I have a tumor or cancer in my bone marrow that can be measured.My lymphoma has been confirmed through specific lab tests.My heart pumps well, with an ejection fraction of 45% or higher.I agree to use effective birth control.I have not had anthracycline treatment in the last 2 years, except for liposomal doxorubicin.I have severe nerve damage or pain.I do not have brain or spinal cord disease related to lymphoma.I have been diagnosed with Hepatitis C.I have not had major surgery in the last 4 weeks.The doctors believe that you may not live for more than 2 months.You are pregnant or currently breastfeeding.I do not have any unmanaged ongoing illnesses.You must not have HIV. You will be tested to make sure you are HIV-negative before the study begins.I can take care of myself but might not be able to do active work.I can do most of my daily activities but might need help.I am on or agree to start HIV treatment if I am HIV-positive.You are currently taking any experimental drugs that are not approved by the FDA.I am HIV positive but haven't had any major HIV-related infections in the last year.My cancer is stage II-IV, or stage I with high LDH or a large tumor.Your medical record shows that you have been diagnosed with HIV by a licensed healthcare provider.My test was FDA-approved.I had cancer before, but it's either cured or not related to my current condition.I have a serious, ongoing illness or infection that is not cancer.My lymphoma has been confirmed through a biopsy.I am on HAART treatment for HIV, as prescribed by a doctor.I have had chemotherapy or radiotherapy for lymphoma, with some exceptions.I am currently taking cobicistat, indinavir, ritonavir, or strong CYP3A4 inhibitors.My white blood cell count is normal or only low due to my cancer.You have a high level of HIV-1 virus in your blood.I have COPD or asthma with severe breathing test results.I have had hepatitis B or it has resolved.My kidney function is within the normal range.I have brain metastases from a solid tumor.You have experienced allergic reactions, hypersensitivity, or intolerance to daratumumab or any other medication used in the study.I have not had a heart attack in the last 6 months.I have been treated with daratumumab for another condition.
- Group 1: Treatment (daratumumab, DA-EPOCH)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
How many sites are managing this research endeavor?
"This trial is now recruiting patients from 6 different geographical locations, including Chapel Hill, Baltimore and Columbus. To reduce the need for travel when participating in this study, participants should select a site close to them."
Is enrollment in this trial still an option for interested participants?
"Affirmative. Clinical trials' online records indicate this research is presently recruiting participants, with the trial's initial posting occurring on 24th May 2021 and its most recent update taking place 12th September 2022. Across 6 medical centres, 15 individuals are needed to complete the study."
What prior studies have been conducted to investigate the efficacy of Daratumumab?
"Currently, 1566 Daratumumab studies are underway with 347 of those in the Phase 3 stage. While most trials for this medication take place in Bethesda, Maryland, there are 61011 sites offering clinical trails across the country."
What maladies has Daratumumab been proven useful in treating?
"Daratumumab is a potent therapeutic agent that has been approved to treat prostate cancer, pheochromocytomas and ulcerative colitis."
Has this treatment protocol been explored before?
"To date, 1566 active trials for Daratumumab have been run in 81 different countries and 3115 cities. Alfacell first began a trial involving 300 participants back in 1997; since then, 2405 studies have been conducted regarding this drug's safety and efficacy. The initial clinical trial achieved its Phase 3 Drug Approval stage of development."
How many volunteers are involved in this clinical trial?
"The Emmes Company, LLC is sponsoring this clinical trial and needs 15 participants that meet the necessary qualifications. The research will be conducted at UNC-Chapel Hill in North carolina, as well as Johns Hopkins University/Sidney Kimmel Cancer Center in Maryland."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How responsive is this trial?
Average response time
- < 1 Day
Most responsive sites:
- Memorial Sloan Kettering Cancer Center: < 24 hours
Typically responds via
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