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Nucleoside Metabolic Inhibitor

Azacitidine for Acute Myeloid Leukemia

Phase 3
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from initiation of study treatment to study completed from 17-may-2021 to 02-dec-2022 (approximately 565 days)
Awards & highlights

Study Summary

This trial is studying azacitidine with or without glasdegib in order to improve outcomes for participants with myelodysplastic syndromes or acute myeloid leukemia.

Eligible Conditions
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome
  • Chronic Myelomonocytic Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from initiation of study treatment to study completed from 17-may-2021 to 02-dec-2022 (approximately 565 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from initiation of study treatment to study completed from 17-may-2021 to 02-dec-2022 (approximately 565 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Treatment Emergent Adverse Event (AE) and Treatment Related AE
Number of Participants With Treatment Emergent Serious Adverse Events (SAE) and Treatment Related SAEs

Side effects data

From 2007 Phase 3 trial • 358 Patients • NCT00071799
67%
Thrombocytopenia
65%
Neutropenia
50%
Constipation
48%
Nausea
48%
Anaemia
43%
Injection site erythema
29%
Injection site reaction
27%
Vomiting
26%
Pyrexia
24%
Fatigue
22%
Diarrhoea
19%
Nasopharyngitis
19%
Cough
18%
Injection site pain
18%
Leukopenia
17%
Acute myeloid leukaemia
15%
Asthenia
15%
Dyspnoea
15%
Epistaxis
14%
Headache
14%
Anorexia
13%
Oedema peripheral
12%
Abdominal pain
12%
Haematoma
11%
Febrile neutropenia
11%
Pneumonia
11%
Transfusion reaction
11%
Petechiae
11%
Pruritus
10%
Oral herpes
10%
Dizziness
10%
Rash
9%
Arthralgia
9%
Back pain
9%
Bronchitis
9%
Insomnia
9%
Upper respiratory tract infection
9%
Hypertension
8%
Weight decreased
8%
Contusion
7%
Haemorrhoids
7%
Erythema
7%
Urinary tract infection
7%
Lethargy
6%
Abdominal pain upper
6%
Muscle spasms
6%
Gingival bleeding
6%
Injection site rash
6%
Influenza
6%
Oral candidiasis
6%
Rhinitis
6%
Pain in extremity
6%
Hypotension
6%
Dyspepsia
6%
Injection site haematoma
6%
Hypokalaemia
6%
Haematuria
6%
Pharyngolaryngeal pain
5%
Chest pain
5%
Mouth ulceration
5%
Musculoskeletal pain
5%
Depression
5%
Oedema
5%
Pharyngitis
5%
Anxiety
5%
Ecchymosis
5%
Injection site bruising
5%
Injection site induration
5%
Dyspnoea exertional
4%
Pain
4%
Bone pain
4%
Alopecia
4%
Skin lesion
3%
Conjunctival haemorrhage
3%
Tachycardia
3%
Stomatitis
3%
Respiratory tract infection
3%
Productive cough
3%
Dry mouth
3%
Gingivitis
3%
Chills
3%
Sinusitis
3%
Sepsis
3%
Fall
3%
Alanine aminotransferase increased
3%
Sleep disorder
2%
Muscular weakness
2%
Neutropenic sepsis
2%
Catheter site haematoma
2%
Hyperuricaemia
2%
Gastritis
2%
Nasal congestion
2%
Purpura
2%
Cardiac failure
2%
Bronchopneumonia
2%
Lymphopenia
2%
Gastrooesophageal reflux disease
2%
Rectal haemorrhage
2%
General physical health deterioration
2%
Pallor
2%
Septic shock
2%
Myelodysplastic syndrome
2%
Cerebral haemorrhage
2%
Pitting oedema
2%
Procedural pain
2%
Syncope
1%
Endophthalmitis
1%
Strabismus
1%
Haematemesis
1%
Salmonella sepsis
1%
Mouth haemorrhage
1%
Gastrointestinal haemorrhage
1%
Myocardial infarction
1%
Benign prostatic hyperplasia
1%
Tooth disorder
1%
Haemorrhoidal haemorrhage
1%
Blood lactate dehydrogenase increased
1%
Fungal skin infection
1%
Subileus
1%
Hypophosphataemia
1%
Joint swelling
1%
Intestinal haemorrhage
1%
Angina pectoris
1%
Angle closure glaucoma
1%
Atrial fibrillation
1%
Eye Haemorrhage
1%
Pancytopenia
1%
Food poisoning
1%
Ventricular tachycardia
1%
Gastrointestinal pain
1%
Conjunctivitis
1%
Transient ischaemic attack
1%
Cellulitis
1%
Clostridium difficile colitis
1%
Oral soft tissue disorder
1%
Perianal abscess
1%
Delirium
1%
Corynebacterium infection
1%
Lung infection
1%
Tooth abscess
1%
Confusional state
1%
Abdominal discomfort
1%
Hypoxia
1%
Psychotic disorder
1%
Herpes zoster
1%
Subcutaneous abscess
1%
Subdiaphragmatic abscess
1%
Anal haemorrhage
1%
Meningitis
1%
Renal colic
1%
Ocular hyperaemia
1%
Catheter site haemorrhage
1%
Catheter site pain
1%
Enterobacter infection
1%
Musculoskeletal chest pain
1%
Peripheral vascular disorder
1%
Pulmonary embolism
1%
Pleural effusion
1%
Cardiac failure acute
1%
Vertigo
1%
Oesophageal carcinoma
1%
Myopia
1%
Retinal artery occlusion
1%
Squamous cell carcinoma of skin
1%
Haemoptysis
1%
Lung infiltration
1%
Respiratory failure
1%
Pulmonary oedema
1%
Pulmonary fibrosis
1%
Hallucination
1%
Colitis ulcerative
1%
Injection site nodule
1%
Bacteraemia
1%
Bile duct stone
1%
Hepatic function abnormal
1%
Fungal sepsis
1%
Gasteroenteritis
1%
Gasteroenteritis salmonella
1%
Laryngopharyngitis
1%
Lobar pneumonia
1%
Lower respiratory tract infection
1%
Pulmonary tuberculosis
1%
Sialoadenitis
1%
Splenic abscess
1%
Staphylococcal bacteraemia
1%
Clavicle fracture
1%
Hip fracture
1%
Traumatic intracranial haemorrhage
1%
Diabetes mellitus
1%
Colon cancer
1%
Lung adenocarcinoma
1%
Neoplasm prostate
1%
Urinary tract neoplasm
1%
Coma
1%
Haemorrhage intracranial
1%
Renal failure
1%
Urethral stenosis
1%
Acute pulmonary oedema
1%
Acute respiratory failure
1%
Hypoalbuminaemia
1%
Hyponatraemia
1%
Lymphadenopathy
1%
Gingival pain
1%
Generalised oedema
1%
Catheter related infection
1%
Neck pain
1%
Dermatitis allergic
1%
Rash macular
1%
Urticaria
1%
Bone marrow failure
1%
Pericardial effusion
1%
Hypothyroidism
1%
Retinal Haemorrhage
1%
Retinal tear
1%
Abdominal wall abscess
1%
Abscess neck
1%
Ear infection
1%
Enterobacter bacteraemia
1%
Mucormycosis
1%
Neutropenic infection
1%
Parotitis
1%
Pneumonia fungal
1%
Synovial rupture
1%
Osteoporosis
1%
Myelofibrosis
1%
Loss of consciousness
1%
Urinary retention
1%
Pneumonitis
1%
Actinic keratosis
1%
Aortic aneurysm
1%
Circulatory collapse
1%
Bronchopulmonary aspergillosis
1%
Bradycardia
1%
Aphthous stomatitis
1%
Mucosal inflammation
1%
Staphylococcal infection
1%
Viral upper respiratory tract infection
1%
Scratch
1%
Thermal burn
1%
Aspartate aminotransferase increased
1%
Hypocalcaemia
1%
Bursitis
1%
Sinus headache
1%
Chromaturia
1%
Proteinuria
1%
Pleurisy
1%
Rash papular
1%
Rash pruritic
100%
80%
60%
40%
20%
0%
Study treatment Arm
Azacitidine
Low-dose Cytarabine
Best Supportive Care Only
Standard Chemotherapy

Trial Design

1Treatment groups
Experimental Treatment
Group I: Participants from B1371019 and B1371012Experimental Treatment2 Interventions
Azacitidine will be administered 75 mg/m2/day for 7 days every 28 days on Days 1-7 (±3 days) per local label or per the IP Manual (or SPC). Azacitidine may be administered by SC injection or IV infusion. Alternate dosing schedules to administer the 7 doses to accommodate participant and treatment center availability are allowed. The starting dose regimen will be the same as the most recent regimen received on the B1371019 or B1371012 study. Glasdegib 50, 75 or 100 mg will be orally administered daily and continuously. The starting dose regimen will be the same as the most recent regimen received on the B1371012 or B1371019 study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Glasdegib
2015
Completed Phase 3
~100
Azacitidine
2012
Completed Phase 3
~1440

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,570 Previous Clinical Trials
10,916,012 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,476 Previous Clinical Trials
8,092,207 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Azacitidine received official sanctioning from the FDA?

"Azacitidine is estimated to be a safe 3 because it has gone through multiple rounds of testing with positive results."

Answered by AI

What are the most similar medical studies to this one that have already been completed?

"Azacitidine is being studied in 183 clinical trials, with 35 of them being Phase 3. Some of these medical studies are based in Saint Louis, Missouri; however, Azacitidine's global clinical trial footprint spans 5782 locations."

Answered by AI

How many people are able to enroll in this research project?

"This trial is not actively recruiting patients at this time. The study was originally posted on 5/17/2021 and was most recently edited on 10/4/2022. However, there are presently 1712 trials actively looking for participants with muscular dystrophy and 183 trials for Azacitidine that are searching for patients."

Answered by AI

For what purpose is Azacitidine most often employed?

"induction chemotherapy typically uses azacitidine. Azacitidine has also shown efficacy in treating refractory anemias, leukemia, myelocytic, acute, and multilineage dysplasia."

Answered by AI

Are there any available openings for participants in this research?

"According to the latest information found on clinicaltrials.gov, this particular study is no longer looking for volunteers. This research was first made public on May 17th, 2021 but has not been updated since October 4th, 2022. Although this investigation is concluded, there are 1,895 other trials that are still recruiting patients."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Continuation Study of B1371019(NCT03416179) and B1371012(NCT02367456) Evaluating Azacitidine With Or Without Glasdegib In Patients With Previously Untreated AML, MDS or CMML
2021. "Continuation Study of B1371019(NCT03416179) and B1371012(NCT02367456) Evaluating Azacitidine With Or Without Glasdegib In Patients With Previously Untreated AML, MDS or CMML". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04842604.
~4 spots leftby Apr 2025
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