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Oral Azacitidine for Acute Myeloid Leukemia
Phase 2
Recruiting
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Newly diagnosed, histologically confirmed de novo Acute Myeloid Leukemia (AML) or AML secondary to prior myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML)
≥ 55 years of age inclusive at the time of signing the informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 50 months
Awards & highlights
Study Summary
This trial will test a new maintenance therapy for AML in Japanese patients 55+ who've already had chemo.
Who is the study for?
This trial is for Japanese individuals aged 55 or older with Acute Myeloid Leukemia (AML) who are in complete remission after intensive chemotherapy. They must not have had prior bone marrow transplants, treatment with hypomethylating agents for MDS that led to AML within four months, or certain types of leukemia like acute promyelocytic leukemia.Check my eligibility
What is being tested?
The study compares the effectiveness and safety of oral azacitidine plus best supportive care versus just best supportive care as maintenance therapy in patients who've achieved remission from AML following chemotherapy.See study design
What are the potential side effects?
Oral azacitidine may cause side effects such as nausea, vomiting, diarrhea, constipation, fatigue and weakness. It can also lower blood cell counts increasing infection risk and causing anemia or bleeding problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been newly diagnosed with AML, either de novo or following MDS/CMML.
Select...
I am 55 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 50 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 50 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Relapse-free Survival (RFS)
Secondary outcome measures
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))
Area under the serum concentration-time curve from time 0 to infinity AUC(INF)
Maximum observed plasma concentration (Cmax)
+11 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%
Prerenal failure
1%
Gastroenteritis
1%
Corona virus infection
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
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Oral AzacitidineExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
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?
Bristol-Myers SquibbLead Sponsor
2,641 Previous Clinical Trials
4,130,049 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment period still ongoing for this trial?
"According to clinicaltrials.gov, this trial is actively recruiting patients and has been open since the 17th of January 2022 with its most recent update on October 16th 2023."
Answered by AI
What potential harm can arise from Oral Azacitidine intake?
"As a result of being in Phase 2, there is evidence that suggests Oral Azacitidine's safety for human use; therefore, it was assigned a score of two."
Answered by AI
How many participants are eligible to partake in this medical trial?
"Affirmative. The clinicaltrials.gov page cites that this trial is in the process of recruiting participants. It was initially posted on January 17th 2022, and the most recent update was October 16th 2023. This medical study requires 15 individuals to be recruited from 65 distinct locations across the globe."
Answered by AI
How many venues are undergoing this experiment?
"This study will accept patients from Local Institution - 0003 in Kashiwa, Aichi; Local Institution - 0023 in Nagoya-shi, Alabama; and Local Institution - 0026 in Osaka, Chiba as well as 65 other sites."
Answered by AI
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