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Brentuximab Vedotin Combination for Hodgkin's Lymphoma
Study Summary
This trial will study two treatment combinations for classical Hodgkin lymphoma (cHL). A side effect is anything the drug does besides treating cancer. This study will have three parts (Parts A, B, and C). Part A will look at whether the A+AVD drug combination reduces the number of participants who experience the side effect of febrile neutropenia. Parts B and C will use drug combination of brentuximab vedotin, plus nivolumab, doxorubicin, and dacarbazine. These four drugs are called "AN+AD."
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 condition is nodular lymphocyte predominant Hodgkin lymphoma.I haven't had cancer, except for certain low-risk types, in the last 3 years.I haven't had chemotherapy, radiation, or immunotherapy in the last 4 weeks.I have not had a stroke or similar brain event in the last 6 months.My cancer has spread to my brain or its coverings.I haven't had a severe infection in the last two weeks.I am not on any other cancer treatments or experimental drugs.I do not have active lung disease that could affect my treatment.I have a history of lung scarring or my lungs are less effective at exchanging gases.My liver function is moderately to severely impaired.I am experiencing graft-versus-host disease or am on immunosuppressive therapy for it.My Hodgkin's lymphoma is either early stage with a large tumor in my chest or is advanced.My Hodgkin's lymphoma is in the early stages and not widespread.My Hodgkin's lymphoma diagnosis is confirmed by tissue analysis.My cancer can be measured in two dimensions on scans.I am at least 12 years old if in the US, or 18 if outside the US.I can care for myself and am up and about more than 50% of my waking hours.I have moderate to severe numbness, tingling, or muscle weakness.I am scheduled for additional radiotherapy to target remaining cancer cells.I have a severe lung condition not caused by my cancer.My cancer is at an advanced stage (Stage III or IV).I have been treated with brentuximab vedotin before.I have been treated with specific immune system targeting drugs.I have classic Hodgkin lymphoma and have not received any treatment.
- Group 1: Part A: A+AVD
- Group 2: Part B: AN+AD
- Group 3: Part C: AN+AD
- 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
Has Granulocyte Colony-Stimulating Factor been sanctioned by the FDA?
"Based on the available data, G-CSF is estimated to have a safety score of 2 as it has been tested in Phase II trials but efficacy has not yet been ascertained."
Is there an opportunity for volunteers to join this experiment?
"No longer recruiting candidates, this clinical trial was initially posted on January 28th 2019 and last updated in September 30th 2022. For those still seeking trials to join, there are 1726 lymphoma studies and 1251 G-CSF investigations actively looking for patients."
Is this a pioneering exploration into the potential of the clinical trial?
"Globally, 1251 live trials of G-CSF are underway in 72 countries and 3154 cities. The first trial for this drug was conducted by Alfacell back in 1997 with 300 participants; since then, a further 1547 studies have been successfully concluded."
How many sites are involved in the implementation of this trial?
"Multiple medical centres are welcoming patients for this trial, including Kadlec Clinic Hematology and Oncology in Kennewick, Washington; Vista Oncology Inc PS in Olympia, Oregon; MD Anderson Cancer Center / University of Texas in Houston, Colorado; plus 44 other sites."
What is the experimental sample size for this research endeavor?
"At the moment, this trial is not soliciting patients. It was first posted on January 28th 2019 and its most recent update occurred September 30th 2022. For those desiring alternative studies, 1726 clinical trials are actively searching for lymphoma participants while 1251 G-CSF trials require volunteers."
What precedent has been set regarding the testing of G-CSF in medical research?
"Initial research on G-CSF was conducted at Spectrum Health Hospital - Butterworth Campus in 1997. Presently, there are 1251 studies actively recruiting participants and a total of 1547 trials have been completed thus far. The majority of these investigations are occurring in the city of Kennewick, Washington."
What illnesses are typically ameliorated with G-CSF?
"G-CSF is primarily used for complete resection, but has also proven to be of use in cases such as cyclic neutropenia, acute lymphoblastic leukemia (ALL), and primary cutaneous anaplastic large cell lymphoma."
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