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Lenalidomide + Combination Chemotherapy for Adult T-Cell Leukemia-Lymphoma
This trial is testing a new cancer treatment regimen that includes the drug lenalidomide. Lenalidomide is already approved for other types of cancer, but its use in this particular cancer is experimental. The goal of the trial is to find the best dose of lenalidomide to give with standard chemotherapy drugs, and to learn about any side effects of this combination treatment.
- Adult T-Cell Leukemia/Lymphoma
- Human T-cell Leukemia Virus-1 Infection
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Awards & Highlights
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Who is running the clinical trial?
- You have previously taken IMiDs (a type of medication) to treat ATLL (a type of cancer).You have had allergic reactions to drugs similar to lenalidomide or other drugs being used in this study. Severe allergic reactions, including cases leading to death, have been reported with cyclophosphamide. There is a chance of having a similar reaction to other drugs in the same class.If you can't take aspirin or certain blood thinners, you won't be able to continue treatment with lenalidomide. However, you can still participate in the initial treatment with lenalidomide plus EPOCH.You can participate if you have been treated with certain medications like AZT, IFN, bexarotene, or mogamulizumab. You can also participate if you had stable disease after receiving chemotherapy in the past and are at high risk of the disease coming back.If you have any kind of demyelinating disease, you cannot receive vincristine sulfate injection.You have a blockage that prevents urine from flowing properly, which makes it unsafe for you to take cyclophosphamide.You have cancer that has spread to the brain or spinal fluid, but if your doctor believes that you don't need immediate treatment for it, you can still participate in the trial.
- Group 1: Treatment (lenalidomide, 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
Could you outline other experiments that have studied the potential of Lenalidomide?
"Lenalidomide was initially assessed in 1997 at Spectrum Health Hospital - Butterworth Campus, and to date there have been 2607 trials on the medication concluded. There are presently 1624 ongoing studies with a considerable amount of them occuring in Uniondale, New Jersey."
Has the federal agency sanctioned lenalidomide for medical use?
"Lenalidomide's safety was scored a 1 out of 3 due to the limited data available from Phase 1 trials, which provides minimal information on efficacy and safety."
Are there vacancies available for volunteers in this clinical experiment?
"Clinicaltrials.gov confirms that enrollment is ongoing for this medical trial, which was initially posted on June 15th 2020 and modified as recently as September 29th 2022."
How widely dispersed is the implementation of this research in America?
"Presently, 13 sites are hosting this medical trial. These sites span from Uniondale, New York to Montvale and several other locations in-between. To best facilitate the process for participants, it is strongly recommended that they select a site as close to their home as possible."
Is this trial a pioneering effort or has it been conducted previously?
"To date, 1624 active trials for lenalidomide have been conducted in 80 nations and 3276 cities. This medication was initially tested as part of a 1997 study sponsored by Alfacell which included 300 patients and culminated with Phase III drug approval. Since then, 2607 trials have taken place across the world."
What is the maximum number of participants accepted into this experiment?
"Affirmative. According to the clinicaltrials.gov website, this experiment is accepting applicants as of now - first being posted on June 15th 2020 and most recently updated on September 29th 2022. It aims to recruit 30 test subjects from 13 distinct sites."
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