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Sorafenib + Chemotherapy for Acute Myeloid Leukemia
Study Summary
This trial is studying the best dose of sorafenib to give with busulfan and fludarabine in treating patients with acute myeloid leukemia.
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 2020 Phase 2 trial • 40 Patients • NCT01900002Trial Design
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Who is running the clinical trial?
Media Library
- I have no other cancers except possibly treated skin, cervical, or superficial bladder cancer, or any cancer cured over 3 years ago.I have a perfect match donor for my transplant.I am not pregnant and have taken a test within the last week to confirm.My leukemia is in its first full remission and is considered low risk.My blood pressure is high despite taking medication.I do not have serious heart problems like recent heart attacks or unstable angina.I have a wound, ulcer, or bone fracture that is not healing.I have a history of bleeding disorders, but not due to low platelet counts.I have not had serious lung bleeding or any other severe bleeding in the last month.I haven't taken strong medication like phenytoin or St. John's wort in the last 28 days.I am not pregnant or breast-feeding.I can follow the study plan and attend all required check-ups.I have not had major surgery in the last 30 days.I have previously been treated with inotuzumab or gemtuzumab.I am between 18 and 70 years old.I have acute myeloid leukemia, regardless of flt3 status.I agree to use birth control from the start of the study until 30 days after the last dose.I can swallow and keep down pills.I have had an organ transplant.I have a condition that affects how my body absorbs nutrients.I am on blood thinners like warfarin or heparin.I haven't had a stroke or similar event in the last 6 months.
- Group 1: Treatment (sorafenib, busulfan, fludarabine, HSCT)
- 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
Is there an opportunity for me to participate in this research endeavor?
"This medical experiment requires 74 test subjects aged between 18 and 70 that have been diagnosed with leukemia. Furthermore, the potential participants must possess a left ventricular ejection fraction (LVEF) of no less than 50%, an available Human leukocyte antigen (HLA)-identical sibling or 8/8 matched unrelated donor, life expectancy greater than 12 weeks, and be between the aforementioned ages."
What medical conditions are usually treated with Sorafenib?
"Sorafenib is a popular medication for treating atopic dermatitis, however it can also be beneficial to those with multiple sclerosis, leukemia, acute myelocytic and psoriasis."
Are there any slots open to join this clinical investigation?
"Affirmative. Clinicaltrials.gov hosts data that verifies the active recruitment of participants for this medical trial, which was made available on July 30th 2017 and last revised on August 18th 2022. This study is planning to recruit 74 patients from 1 site in total."
What is the current size of the cohort engaged in this clinical trial?
"Indeed, the information accessible on clinicaltrials.gov affirms that this medical trial is actively recruiting for participants. This research was initially posted to the website on July 30th 2017 and it has been recently updated on August 18th 2022. The study requires 74 individuals at a single site of enrollment."
Is the minimum age requirement for this trial lower than eighteen years?
"The enrollment parameters for this clinical trial are limited to participants aged 18-70. Separately, there are 817 trials open exclusively to minors and 2040 studies available only for those above the age of 65."
Have there been any other studies related to Sorafenib?
"Presently, 1138 studies are being conducted to assess the efficacy of Sorafenib. Out of these trials, 219 have reached Phase 3 and a large portion is located in Leipzig, Sachsen with additional research sites spread across 33563 locations worldwide."
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