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Pevonedistat + Venetoclax + Azacitidine for Acute Myeloid Leukemia (PEVENAZA Trial)
PEVENAZA Trial Summary
This trial is comparing two different combinations of drugs for treating AML. Pevonedistat + venetoclax + azacitidine will be compared to venetoclax + azacitidine. Bone marrow samples will be collected throughout the study to see how well the treatments are working.
PEVENAZA Trial 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 2 trial • 120 Patients • NCT02610777PEVENAZA Trial Design
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- My AML has affected or has a history of affecting my brain or spinal cord.I have a history of blood cancer with a specific genetic change.My HIV infection is not under control.I've been treated with drugs that affect DNA for my AML, but not for MDS.My high blood pressure does not improve with standard treatments.I have been genetically diagnosed with acute promyelocytic leukemia.I am fit for intensive chemotherapy or a stem cell transplant.I haven't had cancer or been treated for another cancer within the last year.I have liver cirrhosis.I have an infection that is not responding to treatment.My AML cancer is outside the bone marrow and hasn't spread to it.I cannot receive standard chemotherapy due to my age or other health issues.I have been diagnosed with AML according to WHO criteria.I have a bleeding disorder that is not under control.
- Group 1: Venetoclax 100/200/400 mg + Azacitidine 75 mg/m^2
- Group 2: Pevonedistat 20 mg/m^2 + Venetoclax 100/200/400 mg + Azacitidine 75 mg/m^2
- 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
How is Pevonedistat usually deployed therapeutically?
"Pevonedistat is a common inductive chemotherapy. It has also been noted to treat conditions such as refractory anemias, leukemia, myelocytic, acute and multilineage dysplasia."
What is the current sample size of this research project?
"This research program has ceased to recruit participants, with the last edit made on May 25th 2022. However other trials are recruiting; there are 1,532 studies enrolling patients who have leukemia and myelocytic acute conditions and 347 looking for volunteers taking Pevonedistat."
Are there any availabilities for enrollment in this clinical experiment?
"Unfortunately, this clinical trial has concluded recruitment. Initially posted on October 13th 2020 and last updated May 25th 2022, people seeking studies related to leukemia myelocytic acute or Pevonedistat can explore 1532 and 347 actively recruiting trials respectively."
How many sites are currently managing this clinical investigation?
"The trial is now enrolling patients at Mayo Clinic Jacksonville - PPDS in Jacksonville, Florida; Fort Wayne Medical Oncology and Hematology in Fort Wayne, Indiana; Tom Baker Cancer Centre in Calgary, Alberta; as well as 32 other medical centres."
To what degree are individuals at risk when they take Pevonedistat?
"Taking into account the Phase 2 status of Pevonedistat, our team at Power has assessed its safety as a score of 2. This indicates that while some data exists to support its security profile, no evidence currently exists for therapeutic efficacy."
Has research been conducted on Pevonedistat before?
"Initially researched at Chinese University of Hong Kong-Prince of Wales Hospital in 2006, Pevonedistat has since been the focus of 218 finished clinical trials. At present, there are 347 ongoing studies; many being conducted in Jacksonville, Florida."
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