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Brentuximab Vedotin for T-Cell Lymphoma
Study Summary
This trial will study the use of Brentuximab Vedotin in patients with mature T-cell lymphoma who have been treated with at least one type of chemotherapy, but are not responding or the cancer has come back after the previous treatment.
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.Side effects data
From 2017 Phase 2 trial • 10 Patients • NCT01807598Trial Design
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- My condition is anaplastic large cell lymphoma, regardless of ALK status.I have a type of skin lymphoma that is not transformed Mycosis fungoides.I have not taken Brentuximab in the last 6 months or it did not work for me.I have severe nerve damage or Charcot-Marie-Tooth disease.I need treatment for a brain or spinal cord condition.I haven't had cancer in the last 3 years, except for skin cancer or a localized cancer that was treated to cure.I have had progressive multifocal leukoencephalopathy in the past.I have had a heart attack in the last 6 months.You have certain health conditions that may make it difficult for you to take part in the study.I do not have any ongoing or uncontrolled infections.I have a history of liver disease, including hepatitis B or C.I can care for myself but may not be able to do heavy physical work, or I'm mostly in bed due to my lymphoma.You have had an allergic reaction to any part of the medication.I have heart problems like heart failure, blocked arteries, or irregular heartbeats.I haven't had chemotherapy or experimental drugs in the last 2 weeks.My T cell lymphoma has returned or didn't respond to treatment and has low CD30.It has been over 6 weeks since my stem cell transplant.My scans show cancer larger than 1.5 cm or cancer in my spleen/bone marrow.I will use effective birth control during and for 6 months after the study.My liver function tests are within the required limits.I am not pregnant and agree to use birth control during and 6 months after the study.My organs are working well.I have been diagnosed with HIV.I was treated with brentuximab vedotin over 6 months ago and it worked for me.It's been over 3 months since my stem cell transplant, I'm not on immunosuppressants, and I don't have GVHD.I have undergone at least one chemotherapy treatment.
- Group 1: Brentuximab vedotin
- 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
To what purpose is Brentuximab vedotin most often put?
"Brentuximab vedotin, while most often used as a hodgkin disease treatment, can also be effective for patients with systemic anaplastic large cell lymphoma, peripheral t-cell lymphoma, and previously untreated."
What is the difference between this clinical trial and others like it?
"Brentuximab vedotin has been under investigation since 2011 when the first study was conducted by Seagen Inc. After this initial Phase 1 clinical trial with 79 patients, Brentuximab vedotin received approval for Phase 2 trials. Currently, there are 62 active studies involving 31 countries and 627 cities."
Has Brentuximab vedotin been cleared by the FDA?
"Brentuximab vedotin is classified as a Phase 2 drug, which means that while there is some evidence suggesting it is safe, there is no data yet to support its efficacy."
Are there any active vacancies in this clinical trial for new patients?
"Yes, the trial is still ongoing and looking for new participants. The original posting was on 6/17/2016, with the most recent update being on 7/18/2022. 31 people are needed from 2 different locations."
How many people will be included in this research project at most?
"Yes, according to the latest information from clinicaltrials.gov, this trial is still recruiting patients. The listing for this study was first posted on June 17th, 2016 and updated as recently as July 18th, 2022. At present, they are looking for 31 individuals at 2 different sites."
Is Brentuximab vedotin a new medication?
"62 clinical trials are currently being conducted to study the efficacy of Brentuximab vedotin. Of those, 6 have reached Phase 3. However, these trials are not limited to Montvale, New jersey as there are 1,851 total locations running these sorts of studies."
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