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Chemotherapy + Immunotherapy for Hodgkin's Lymphoma
Study Summary
This trial is testing a combination of drugs to see if they're effective in treating Hodgkin lymphoma. The drugs work in different ways to stop the growth of cancer cells. The trial may improve survival of patients with stage I-II Hodgkin 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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- My hemoglobin level is at least 8.5 g/dL without recent blood transfusions.My white blood cell count is healthy without needing a recent blood transfusion.I have a large tumor (10 cm or larger) according to a CT scan.I am not taking any experimental drugs for my cancer.I have not had severe infections, pancreatitis, stroke, or TIA in the recent past.My cancer can be measured and is at least 1.5 cm big on a CT scan.My kidney function, measured by creatinine levels, is within the required range.I have an autoimmune disease but only need hormone replacement or no systemic treatment.I am currently on IV antibiotics for an infection.I have been diagnosed with HIV.I am currently breastfeeding.I have had radiation therapy targeting a specific area.My kidneys are not working well (creatinine clearance < 40 mL/min).I have heart problems that cause symptoms.I have an active tuberculosis infection.I am allergic to NVB or components in AVD + BV therapy.My Hodgkin lymphoma is in an early stage and the tumor is smaller than 10 cm.I have had cancer before, but it has been in remission for at least 3 years, except for certain types which are exempt.I can take care of myself and am up and about more than half of the day.My white blood cell count is healthy without recent transfusions.My liver tests are within normal limits.I agree to use birth control from the start of the study until 31 weeks after it ends.My cancer has spread to my brain or spinal cord.I am using birth control and will continue for 6 months after my last treatment dose.I have tested negative for HIV, hepatitis B (unless from vaccination), and hepatitis C in the last year.I need treatment that may affect my liver.You have a history of severe skin reactions or nerve damage.I have taken a pregnancy test with negative results within the last week.You have had allergic reactions or bad side effects from the ingredients in the study drug.You are expected to live for at least 3 more months.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.I have been on high-dose steroids (more than 10 mg/day of prednisone or equivalent) for 2 weeks or more.I have not received a live vaccine within the last 30 days.I have not taken immunosuppressive drugs or steroids in the last 7 days.My liver is not working well (Child-Pugh score > 6).I have active hepatitis B or C.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I am of childbearing age and do not plan to use birth control.
- Group 1: Treatment (combination chemotherapy, nivolumab)
- 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
What is the enrollment capacity for this clinical trial?
"At this juncture, the clinical trial is not enrolling. Initially posted on October 13th 2017 and last updated July 5th 2022, if you are exploring other medication trials, there are 1724 investigations searching for patients with Ann Arbor Stage IIA Hodgkin Lymphoma as well 1180 studies utilizing Brentuximab Vedotin recruiting participants."
What medical condition is Brentuximab Vedotin most regularly used to address?
"Brentuximab Vedotin is most often prescribed to patients who have undergone full removal of their disease, however it can be used in other cases such as primary cutaneous anaplastic large cell lymphoma, newly diagnosed therapy-related acute myeloid leukemia and all forms of acute lymphoblastic leukaemia."
What type of participant would be most suitable for this clinical research?
"The current clinical trial is only open to individuals aged 18-60 who have been diagnosed with Ann Arbor Stage IIa Hodgkin Lymphoma. Around 82 participants are being sought after for this study."
Are there any preceding investigations that involved Brentuximab Vedotin?
"At this moment, there are 1180 Brentuximab Vedotin trials in progress - 227 of which are currently on Phase 3. The primary research site is located in Candiolo, TO; however, studies for this therapy can be found at 67543 other locations globally."
Has Brentuximab Vedotin been cleared by the FDA?
"Brentuximab Vedotin's safety is estimated to be a 2 due to the lack of data confirming it effectiveness. However, there are some studies that suggest its safe usage and application in clinical practice."
Are there any available opportunities for individuals to participate in this investigation?
"Per clinicaltrials.gov, this trial is not presently recruiting patients; it was initially posted on October 13th 2017 and last amended on July 5th 2022. However, there are a plethora of other medical studies actively looking for participants at the moment--2904 to be exact."
How many medical centers are involved in this trial's implementation?
"Patients can enroll in this experiment at University of Washington Medical Center - Montlake, Hackensack University Medical Center and the University of Pennsylvania/Abramson Cancer Centre. These are just three from a total nine trial sites."
Is this clinical trial a pioneering endeavor?
"Alfacell began researching Brentuximab Vedotin as early as 1997 and the first clinical trial, involving 300 patients, was sponsored by them. Subsequent Phase 3 approval allowed for additional studies to be conducted; currently 1180 trials are ongoing in 75 countries across 3048 cities worldwide."
Is this research study accessible to those below the age of fifty?
"This trial is reserved for individuals between 18 and 60 years old. However, there are 475 trials available to those under the age of majority and 2613 studies tailored towards elderly patients."
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