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Nucleoside metabolic inhibitor
Pevonedistat + Venetoclax + Azacitidine for Acute Myeloid Leukemia (PEVENAZA Trial)
Phase 2
Waitlist Available
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Is unfit for treatment with a standard arabinosylcytosine (Ara-C) and anthracycline induction regimen due to age or co-morbidities.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights
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.
Who is the study for?
Adults recently diagnosed with Acute Myeloid Leukemia (AML) who can't undergo intensive chemotherapy due to age or health issues like poor performance status, heart or lung problems, reduced kidney function, or liver disorders. Participants should not have had certain prior treatments for AML, no genetic acute promyelocytic leukemia, and must be unfit for stem cell transplantation.Check my eligibility
What is being tested?
The trial is testing if adding Pevonedistat to the combination of Venetoclax and Azacitidine improves outcomes in AML patients compared to just Venetoclax and Azacitidine. Patients will receive these drugs in cycles lasting 28 days each and may continue treatment as long as it's beneficial.See study design
What are the potential side effects?
Potential side effects include reactions at the infusion site, fatigue, nausea, low blood counts leading to increased infection risk or bleeding complications. Organ-specific side effects such as heart or liver issues could also occur.
PEVENAZA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I cannot receive standard chemotherapy due to my age or other health issues.
PEVENAZA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Event-Free Survival (EFS)
Secondary outcome measures
Duration of CR and CRi
Overall Response Rate (ORR)
Overall Survival (OS)
+8 moreSide effects data
From 2021 Phase 2 trial • 120 Patients • NCT0261077747%
Constipation
45%
Nausea
44%
Anaemia
40%
Fatigue
35%
Pyrexia
34%
Cough
34%
Neutropenia
27%
Diarrhoea
26%
Dyspnoea
24%
Febrile neutropenia
24%
Thrombocytopenia
21%
Decreased appetite
21%
Asthenia
21%
Vomiting
19%
Arthralgia
18%
Hypokalaemia
16%
Abdominal pain
15%
Oedema peripheral
15%
Dizziness
13%
Pneumonia
13%
Back pain
13%
Headache
13%
Pruritus
11%
Platelet count decreased
11%
Bronchitis
11%
Injection site pain
11%
Insomnia
11%
Chills
10%
Epistaxis
10%
Fall
10%
Neutrophil count decreased
10%
Oral herpes
10%
Oropharyngeal pain
10%
White blood cell count decreased
8%
Erythema
8%
Aspartate aminotransferase increased
8%
Hypomagnesaemia
8%
Muscular weakness
8%
Stomatitis
8%
Urinary tract infection
8%
Weight decreased
8%
Pleural effusion
6%
Dehydration
6%
Musculoskeletal pain
6%
Hypophosphataemia
6%
Contusion
6%
Pain in extremity
6%
Productive cough
6%
Non-cardiac chest pain Pain
6%
Sepsis
6%
Alanine aminotransferase increased
6%
Hypoalbuminaemia
6%
Hypocalcaemia
6%
Hyponatraemia
6%
Malaise
6%
Nasal congestion
6%
Non-cardiac chest pain
6%
Oral candidiasis
6%
Petechiae
6%
Nasopharyngitis
3%
Cellulitis
3%
Cerebrovascular accident
3%
Gastric haemorrhage
2%
Atrial fibrillation
2%
Congestive cardiomyopathy
2%
Acute febrile neutrophilic dermatosis
2%
Embolic stroke
2%
Endocarditis
2%
Failure to thrive
2%
Gastrointestinal necrosis
2%
Hepatic lesion
2%
Lower respiratory tract infection
2%
Lung infiltration
2%
Multiple organ dysfunction syndrome
2%
Myocardial infarction
2%
Wound infection
2%
Postoperative hypotension
2%
Acute myeloid leukaemia
2%
Ankle fracture
2%
Arthritis
2%
Arthritis reactive
2%
Autoimmune haemolytic anaemia
2%
Bacteraemia
2%
Bacterial sepsis
2%
Bronchopulmonary aspergillosis
2%
Cauda equina syndrome
2%
Cholecystitis
2%
Drug hypersensitivity
2%
Gastrointestinal ulcer perforation
2%
Haematuria
2%
Haemorrhage intracranial
2%
Hypoxia
2%
Influenza
2%
Inguinal hernia
2%
Ischaemic gastritis
2%
Leukopenia
2%
Myelodysplastic syndrome
2%
Myelodysplastic syndrome transformation
2%
Post procedural hypotension
2%
Rectal haemorrhage
2%
Renal colic
2%
Respiratory tract infection
2%
Soft tissue infection
2%
Spinal compression fracture
2%
Urinary tract infection enterococcal
2%
Urinary tract obstruction
2%
Lung infection
2%
Chronic kidney disease
2%
Death
2%
Gastritis erosive
2%
Supraventricular tachycardia
2%
Thrombophlebitis superficial
100%
80%
60%
40%
20%
0%
Study treatment Arm
Azacitidine 75 mg/m^2
Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2
PEVENAZA Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Pevonedistat 20 mg/m^2 + Venetoclax 100/200/400 mg + Azacitidine 75 mg/m^2Experimental Treatment3 Interventions
Pevonedistat 20 mg/m^2 as a 60-minute IV infusion on Days 1, 3, and 5 in each 28-day cycle plus venetoclax 100 mg tablet orally on Day 1; 200 mg on Day 2; thereafter, at 400 mg on Day 3 through Day 28 in Cycle 1 (cycle length= 28 days) and 400 mg on Days 1 through 28 in Cycle 2 and beyond if tolerated. Following the confirmation of remission in Cycle 1 or thereafter, venetoclax 400 mg was administered on Day 1 through 21 or 28 as per Investigator's discretion, plus azacitidine 75 mg/m^2 IV or SC dosing on Day 1 through 7 or Days 1 through 5, Days 8, and 9 in each cycle up to primary completion date: 06 September 2022.
Group II: Venetoclax 100/200/400 mg + Azacitidine 75 mg/m^2Active Control2 Interventions
Venetoclax 100 mg tablet orally on Day 1; 200 mg on Day 2; thereafter, at 400 mg on Day 3 through Day 28 in Cycle 1 (cycle length= 28 days) and 400 mg on Days 1 through 28 in Cycle 2 and beyond if tolerated. Following the confirmation of remission in Cycle 1 or thereafter, venetoclax 400 mg was administered on Day 1 through 21 or 28 as per Investigator's discretion, plus azacitidine 75 mg/m^2 intravenous (IV) or subcutaneous (SC) dosing on Days 1 through 7 or Days 1 through 5, Days 8, and 9 in each cycle up to primary completion date: 06 September 2022.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pevonedistat
2021
Completed Phase 2
~290
Azacitidine
2012
Completed Phase 3
~1440
Venetoclax
2019
Completed Phase 3
~1990
Find a Location
Who is running the clinical trial?
TakedaLead Sponsor
1,202 Previous Clinical Trials
4,178,098 Total Patients Enrolled
Medical Director Clinical ScienceStudy DirectorTakeda
197 Previous Clinical Trials
63,083 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,207 Previous Clinical Trials
489,516 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- 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
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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