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Oral Azacitidine for Acute Myeloid Leukemia (QUAZAR AML-001 Trial)
Phase 3
Waitlist Available
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status - 0, 1, 2, 3
Male or female participants ≥ 55 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to cycle 2, day 1 (c2d1), c3d1, c4d1, c5d1, c6d1, c7d1, c8d1, c9d1c3, c10d1, c11d1, c12d1, c13d1, c14d1, c15d1, c15d1, c16d1, c17d1, c18d1, c19d1, c20d1, c21d1, c22d1, c23d1, c24d1, c25d1 and continued on day 1 at each cycle through c33d1
Awards & highlights
QUAZAR AML-001 Trial Summary
This trial is studying oral azacitidine to see how well it works in treating patients with acute myeloid leukemia or myelodysplastic syndromes.
Who is the study for?
This trial is for people aged 55 or older with a type of blood cancer called acute myeloid leukemia (AML), who have achieved remission after initial chemotherapy. They must be able to perform daily activities on their own or with some help (ECOG status 0-3). Those with certain genetic mutations in their leukemia, recent other cancers, CNS leukemia, or previous bone marrow transplants can't join.Check my eligibility
What is being tested?
The study tests if taking oral Azacitidine helps maintain remission in AML patients compared to a placebo. Participants are randomly assigned to either the drug or placebo group and may continue treatment if beneficial. The extension phase tracks survival rates even after unblinding when the drug becomes commercially available.See study design
What are the potential side effects?
Oral Azacitidine might cause nausea, vomiting, diarrhea, constipation, fatigue and weakness. There's also a risk of lowered blood cell counts leading to increased infection risk, bleeding problems or anemia. Side effects vary from person to person.
QUAZAR AML-001 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can care for myself but may not be able to do heavy physical work.
Select...
I am 55 years old or older.
Select...
I have been newly diagnosed with AML or AML that developed from a previous blood disorder.
QUAZAR AML-001 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to cycle 2, day 1 (c2d1), c3d1, c4d1, c5d1, c6d1, c7d1, c8d1, c9d1c3, c10d1, c11d1, c12d1, c13d1, c14d1, c15d1, c15d1, c16d1, c17d1, c18d1, c19d1, c20d1, c21d1, c22d1, c23d1, c24d1, c25d1 and continued on day 1 at each cycle through c33d1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to cycle 2, day 1 (c2d1), c3d1, c4d1, c5d1, c6d1, c7d1, c8d1, c9d1c3, c10d1, c11d1, c12d1, c13d1, c14d1, c15d1, c15d1, c16d1, c17d1, c18d1, c19d1, c20d1, c21d1, c22d1, c23d1, c24d1, c25d1 and continued on day 1 at each cycle through c33d1
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Kaplan-Meier (K-M) Estimate for Overall Survival (OS)
Secondary outcome measures
Healthcare Resource Utilization (HRU): Number of Days Hospitalized Per Person-Year
Healthcare Resource Utilization (HRU): Rate of Hospital Events Per Person Year
Kaplan-Meier Estimate of Relapse Free Survival (RFS)
+9 moreSide effects data
From 2023 Phase 3 trial • 216 Patients • NCT0156669576%
Nausea
68%
Diarrhoea
63%
Vomiting
49%
Neutropenia
47%
Constipation
28%
Pyrexia
27%
Thrombocytopenia
27%
Febrile neutropenia
27%
Oedema peripheral
26%
Epistaxis
25%
Decreased appetite
23%
Asthenia
21%
Fatigue
20%
Petechiae
18%
Anaemia
15%
Cough
14%
Contusion
13%
Abdominal pain
12%
Dyspnoea
12%
Back pain
11%
Urinary tract infection
11%
Hypokalaemia
9%
Weight decreased
9%
Leukopenia
9%
Insomnia
9%
Pneumonia
9%
Mouth haemorrhage
9%
Hypomagnesaemia
9%
Haematoma
8%
Anxiety
8%
Alanine aminotransferase increased
8%
Arthralgia
7%
Sepsis
7%
Dizziness
7%
Gingival bleeding
7%
Upper respiratory tract infection
7%
Pain in extremity
6%
Depression
6%
Confusional state
6%
Septic shock
6%
Gastrooesophageal reflux disease
6%
Cellulitis
6%
Oral herpes
6%
Serum ferritin increased
6%
Hyperglycaemia
6%
Iron overload
6%
Ecchymosis
6%
Hypotension
5%
Neutropenic sepsis
4%
Fall
3%
Lung infection
3%
General physical health deterioration
3%
Cardiac failure congestive
2%
Tachyarrhythmia
2%
Bone marrow failure
2%
Cardiac failure
2%
Multiple organ dysfunction syndrome
2%
Cholecystitis
2%
Hyperbilirubinaemia
2%
Atypical pneumonia
2%
Bronchopulmonary aspergillosis
2%
Subdural haematoma
2%
Haemorrhage intracranial
2%
Acute kidney injury
2%
Renal failure
1%
Gastroenteritis
1%
Corona virus infection
1%
Prerenal failure
1%
Escherichia sepsis
1%
Myocardial infarction
1%
Abdominal pain upper
1%
Gastritis
1%
Epididymitis
1%
Febrile infection
1%
Pancytopenia
1%
Renal colic
1%
Chronic kidney disease
1%
Lethargy
1%
Groin abscess
1%
Lower respiratory tract infection
1%
Device related infection
1%
Influenza
1%
Klebsiella infection
1%
Haemolytic anaemia
1%
Haemorrhagic anaemia
1%
Acute myocardial infarction
1%
Angina unstable
1%
Atrial fibrillation
1%
Gastrointestinal haemorrhage
1%
Intestinal obstruction
1%
Intestinal perforation
1%
Neutropenic colitis
1%
Oesophageal achalasia
1%
Oral mucosal blistering
1%
Rectal haemorrhage
1%
Gait disturbance
1%
Hypothermia
1%
Abscess limb
1%
Arteriovenous fistula site infection
1%
Klebsiella sepsis
1%
Meningitis
1%
Meningitis bacterial
1%
Myringitis
1%
Pneumonia fungal
1%
Pneumonia pneumococcal
1%
Pseudomonal sepsis
1%
Pulmonary mycosis
1%
Respiratory tract infection
1%
Skin infection
1%
Staphylococcal infection
1%
Urinary tract infection bacterial
1%
Viral sepsis
1%
Periorbital haematoma
1%
Febrile nonhaemolytic transfusion reaction
1%
Head injury
1%
Hip fracture
1%
Subdural haemorrhage
1%
Upper limb fracture
1%
Dehydration
1%
Diabetes mellitus inadequate control
1%
Diabetic metabolic decompensation
1%
Hyperkalaemia
1%
Hypoglycaemia
1%
Muscular weakness
1%
Polychondritis
1%
Acute myeloid leukaemia
1%
Bone neoplasm
1%
Bowen's disease
1%
Colon adenoma
1%
Mantle cell lymphoma recurrent
1%
Spinal cord neoplasm
1%
Central nervous system lesion
1%
Transient ischaemic attack
1%
Epilepsy
1%
Generalised tonic-clonic seizure
1%
Acute respiratory distress syndrome
1%
Pleural effusion
1%
Pleurisy
1%
Pneumonia aspiration
1%
Pulmonary embolism
1%
Respiratory failure
1%
Hypersensitivity vasculitis
1%
Rash
1%
Rash generalised
1%
Shock haemorrhagic
1%
Cardiogenic shock
1%
Intra-abdominal haemorrhage
1%
Status epilepticus
1%
Syncope
1%
Urinary retention
1%
Prostatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oral Azacitidine Plus Best Supportive Care
Placebo Plus Best Supportive Care
QUAZAR AML-001 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Oral AzacitidineExperimental Treatment1 Intervention
300 mg oral azacitidine on days 1 to 14 of each 28-day treatment cycle.
Group II: PlaceboPlacebo Group1 Intervention
Identically matching placebo tablets on days 1 to 14 of each 28-day treatment cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oral Azacitidine
2013
Completed Phase 3
~480
Find a Location
Who is running the clinical trial?
CelgeneLead Sponsor
636 Previous Clinical Trials
128,499 Total Patients Enrolled
Barry Skikne, MDStudy DirectorCelgene Corporation
2 Previous Clinical Trials
270 Total Patients Enrolled
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,506 Previous Clinical Trials
3,369,058 Total Patients Enrolled
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Oral Azacitidine
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the FDA's current stance on Oral Azacitidine?
"There is some data to support the efficacy of oral azacitidine, as well as multiple rounds of data affirming its safety. Therefore, our team has given it a score of 3."
Answered by AI
How many research subjects are participating in this clinical trial?
"Currently, this trial is not looking for new patients. The last update to the posting was on November 16th, 2022. If you are interested in other trials, there are 1519 studies actively recruiting participants with leukemia, myeloid, acute and 179 Oral Azacitidine studies presently underway."
Answered by AI
What is the main condition that Oral Azacitidine works to improve?
"Azacitidine, which is taken orally, is most often prescribed to cancer patients. Additionally, it can be used as a form of treatment for conditions such as 20-30% blasts, neutropenia and/or thrombocytopenia, and anemia."
Answered by AI
Are there similar treatments to azacitidine that have been studied before?
"Azacitidine, in pill form, was first trialled at Chinese University of Hong Kong-Prince of Wales Hospital in 2006. Since then, there have been 18446 completed trials with 179 active studies as of now. A large portion of these ongoing studies are based out of Yakima, Washington."
Answered by AI
How many facilities are needed to support this research?
"Enrollment for this study is ongoing at 69 clinical sites, many of which are situated in or near large cities such as Yakima, New york and Seattle. To reduce the inconvenience of travel, patients are encouraged to choose a trial site close to their home."
Answered by AI
Are we still able to enroll people in this research project?
"Unfortunately, this particular study is not taking on any new patients at the moment. However, there are 1698 other clinical trials that might be a match for individuals seeking medical treatment. The original trial was posted on April 24th, 2013 and updated November 16th, 2020 according to information found on clinicaltrials.gov"
Answered by AI
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