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Asciminib + Imatinib for Chronic Myeloid Leukemia
Study Summary
This trial will study the effects of a new drug on patients with chronic myeloid leukemia who have attempted to discontinue imatinib.
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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Who is running the clinical trial?
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- I can care for myself but may not be able to do heavy physical work.I have completed 12 cycles of combination therapy.I have chronic phase CML with a specific protein variant.I have had a stem cell transplant from a donor.I have undergone surgery to prevent pregnancy or fathering children.My test results show a stable low level of cancer for over 2 years.I can care for myself but may not be able to do heavy physical work.I have been retaking imatinib for at least a year after my first treatment failed and plan to continue it.I am a male and agree to follow the birth control requirements.I have tried stopping imatinib once before with my doctor's advice.My cancer returned after stopping imatinib with a specific test result.I have been postmenopausal for at least one year.I am 18 years old or older.I agree to practice true abstinence as a form of contraception.I am a woman who is not pregnant, not breastfeeding, and not able to become pregnant.My tests show a stable and low level of cancer cells for at least three tests.My leukemia has entered an advanced stage.You cannot have taken any other experimental medication within the past four weeks before joining the study.I have had pancreatitis in the last year.I agree to practice true abstinence as a form of contraception.I am currently being treated for another cancer.I have been treated with asciminib before.I have been treated with imatinib for at least three years before stopping it.
- Group 1: Combination Therapy and Remission Phase
- 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 this research still looking for participants?
"The study, which was most recently updated on May 3rd, 2022, is still recruiting patients as noted on clinicaltrials.gov. This information was originally posted on November 11th, 2021."
How many people are being given the chance to participate in this clinical trial?
"That is correct, the online clinicaltrials.gov database shows that this study is open for recruitment. This particular trial was posted on November 11th, 2021 and was edited most recently on May 3rd, 2022. The research team plans to enroll 51 individuals from 2 different locations."
What is the usual purpose of taking Asciminib?
"Asciminib is used to treat several conditions, including newly diagnosed acute lymphoblastic leukaemia, refractory acute lymphoblastic leukemia (all), metastatic dermatofibrosarcoma protuberans."
Has the FDA cleared Asciminib for use?
"While there is some evidence to support the safety of Asciminib, it only received a score of 2 because this medication has not been proven effective yet in clinical trials."
Are there other scientific papers which feature Asciminib?
"At the moment, there are 65 different clinical trials testing Asciminib. Out of those, 19 are in Phase 3. Most of these studies are located in Adelaide, South Australia; however, 2050 research centres around the world are runningasciminib trials."
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