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Pevonedistat + Decitabine for Acute Myeloid Leukemia
Study Summary
This trial is testing pevonedistat + decitabine to treat patients with high risk acute myeloid leukemia. This may stop cancer cell growth by blocking enzymes needed for cell growth.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 1 & 2 trial • 24 Patients • NCT03010358Trial Design
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- You do not have any other active cancer except for certain types that have been cured or treated a long time ago.You have a serious medical or mental health condition that could affect your ability to participate in the study.You have not taken any experimental medications within the 2 weeks before starting the study.You have a condition where the disease has spread to your brain or spinal cord.You are 60 years or older and your disease has come back or is not responding to treatment.If you have cancer cells that have spread outside of your bone marrow, you may still be eligible for the study if you meet other criteria.You have other medical conditions, but they are not expected to shorten your life expectancy within the next six months.You should be able to perform daily activities without assistance.You are a young patient with acute myeloid leukemia that has come back or is not responding to treatment, and you cannot receive a stem cell transplant.Women who can have children and men must use effective birth control methods or abstain from sex during the study and for 4 months after it ends, because it is not known how the study drugs may affect a developing fetus. If a woman becomes pregnant or thinks she might be pregnant while in the study, she should tell her doctor right away.You are 60 years or older and have recently been diagnosed with a condition that requires chemotherapy. However, you do not want to undergo the standard treatment of cytarabine/anthracyclines or are not eligible for it.If you have sex and it is part of your regular lifestyle, you must use a reliable form of birth control. Avoiding sex during certain times or using less reliable methods like withdrawal or spermicides are not acceptable forms of birth control.You may have had a bone marrow transplant for leukemia or other diseases.You can take hydroxyurea to control your blood count before and during the first cycle of treatment, but not after that.You are a younger adult with a certain type of high-risk disease that requires aggressive treatment with chemotherapy and/or a stem cell transplant, but you do not want to or cannot undergo these treatments.You are either postmenopausal for at least a year, have had a surgical procedure to prevent pregnancy, or are not currently pregnant but have the ability to become pregnant.You can have had any number of previous chemotherapy treatments.You have a serious illness that is not related to cancer and could be life-threatening.I'm sorry, but the criterion you provided is incomplete. Can you please provide me with more details so that I can summarize it for you?You are currently breastfeeding or pregnant.
- Group 1: Treatment (pevonedistat, decitabine)
- 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
What ailments are commonly addressed by Pharmacological Study?
"Pharmacological Study is regularly used to treat ipss risk category intermediate-2, as well as other conditions such as high ipssrisk , refractory anemias, and anemia."
Are there any vacancies available for prospective participants in this trial?
"The entry hosted on clinicaltrials.gov indicates that this specific trial is not presently recruiting participants, having first been posted in August 2017 and last edited in February 2022. However, there are currently 1,654 other active medical studies searching for patients to join their trials."
Has there been any historical precedent for this particular pharmaceutical experiment?
"Currently, there are 116 Pharmacological Study clinical trials in progress. Of those, 17 have made it to Phase 3 and 1952 different locations are participating worldwide. Particularly, Harrison, New york is a primary hub for these studies."
Has the Pharmacological Study received official approval from the FDA?
"The perceived safety of this pharmacological study is assessed at a 1, given that it is only in the initial stage and limited data exists to support its efficacy and security."
What is the scope of enrollment for this trial?
"Unfortunately, this clinical trial is currently not recruiting. The study was originally posted on August 21st 2017 and has most recently been updated on February 17th 2022. If you are interested in similar studies, there are 1538 active trials for patients with leukemia, myelocytic acute and 116 Pharmacological Study trials actively searching for participants."
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