azacitidine for Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Henry ford hospital, Detroit, MI
Cancer+1 More
azacitidine - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether azacitidine can help decrease the rate of donor chimerism decreasing after stem cell transplantation.

See full description

Eligible Conditions

  • Cancer
  • Myeloid Malignancy

Treatment Effectiveness

Study Objectives

This trial is evaluating whether azacitidine will improve 1 primary outcome in patients with Cancer. Measurement will happen over the course of one year.

one year
The rate of increase or stable donor chimerism

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Intensive Study: Glasdegib + Cytarabine + Daunorubicin
Nausea
56%
Anaemia
51%
Febrile neutropenia
49%
Diarrhoea
48%
Pyrexia
42%
Platelet count decreased
39%
Hypokalaemia
38%
Constipation
36%
White blood cell count decreased
32%
Vomiting
29%
Neutrophil count decreased
28%
Decreased appetite
26%
Thrombocytopenia
26%
Rash
23%
Neutropenia
21%
Hypophosphataemia
21%
Headache
20%
Alanine aminotransferase increased
20%
Dysgeusia
20%
Pneumonia
16%
Hypoalbuminaemia
16%
Abdominal pain
16%
Fatigue
16%
Aspartate aminotransferase increased
15%
Stomatitis
15%
Hypomagnesaemia
15%
Insomnia
14%
Blood bilirubin increased
13%
Oedema peripheral
13%
Hypocalcaemia
13%
Cough
12%
Hyponatraemia
12%
Dizziness
12%
Electrocardiogram QT prolonged
11%
Back pain
11%
Alopecia
11%
Rash maculo-papular
11%
Weight decreased
11%
Muscle spasms
10%
Epistaxis
10%
Lymphocyte count decreased
10%
Chills
10%
Oropharyngeal pain
10%
Arthralgia
9%
Blood creatinine increased
9%
Hypotension
9%
Bacteraemia
8%
Asthenia
8%
Dyspnoea
8%
Sepsis
8%
Myalgia
8%
Non-cardiac chest pain
7%
Blood alkaline phosphatase increased
7%
Haemorrhoids
7%
Proctalgia
7%
Hyperuricaemia
7%
Dry skin
7%
Mucosal inflammation
6%
Pruritus
6%
Dyspepsia
6%
Paraesthesia
6%
Gamma-glutamyltransferase increased
6%
Sinus tachycardia
6%
Abdominal pain upper
6%
Leukopenia
5%
Oedema
5%
Hyperglycaemia
5%
Hypertension
5%
Upper respiratory tract infection
5%
Petechiae
4%
Urinary tract infection
3%
Pseudomonal bacteraemia
2%
Atrial fibrillation
2%
Gastrointestinal haemorrhage
2%
Infection
2%
Enterocolitis
1%
Pneumonia fungal
1%
Graft versus host disease in gastrointestinal tract
1%
Graft versus host disease in skin
1%
Escherichia sepsis
1%
Cerebral haemorrhage
1%
Malaise
1%
Cholelithiasis
1%
Fall
1%
Acute kidney injury
1%
Fungal infection
1%
Adjustment disorder with depressed mood
1%
Acute respiratory distress syndrome
1%
Hypoxia
1%
Haemorrhage intracranial
1%
Syncope
1%
Splenic necrosis
1%
Clostridial sepsis
1%
Peritonitis
1%
Urethritis
1%
Pulmonary haemorrhage
1%
Clostridium colitis
1%
Herpes ophthalmic
1%
Orthostatic hypotension
1%
Soft tissue infection
1%
Hyperbilirubinaemia
1%
Clostridium difficile colitis
1%
Cardiac failure acute
1%
Upper gastrointestinal haemorrhage
1%
Cardiac arrest
1%
Disease progression
1%
Arthritis infective
1%
Septic shock
1%
Lower gastrointestinal haemorrhage
1%
Bronchopulmonary aspergillosis
1%
Neutropenic sepsis
1%
Myocarditis
1%
Escherichia bacteraemia
1%
Cellulitis
1%
Pseudomembranous colitis
1%
Leukocytosis
1%
Respiratory failure
1%
Anal fistula
1%
Acute myocardial infarction
1%
Gastric ulcer
1%
Intussusception
1%
Small intestinal haemorrhage
1%
Enterococcal bacteraemia
1%
Groin abscess
1%
Pulmonary tuberculosis
1%
Acute respiratory failure
1%
Erythema
1%
Disseminated varicella zoster virus infection
0%
Embolism
0%
Seizure
0%
Cerebral infarction
0%
Haematemesis
0%
Carotid artery stenosis
0%
Cardiorenal syndrome
0%
Splenic rupture
0%
Herpes zoster
0%
Device related infection
0%
Mechanical ileus
0%
Suspected COVID-19
0%
Wound infection
0%
Tooth fracture
0%
Soft tissue necrosis
0%
Haematuria
0%
Injection site reaction
0%
Anorectal infection
0%
Febrile infection
0%
Fungal sepsis
0%
Streptococcal sepsis
0%
Pulmonary alveolar haemorrhage
0%
Anal fissure
0%
Herpes dermatitis
0%
Central nervous system lesion
0%
Gastritis
0%
Neutropenic colitis
0%
Death
0%
Differentiation syndrome
0%
Synovitis
0%
Atrial flutter
0%
Haemorrhoids thrombosed
0%
Brain abscess
0%
Atypical pneumonia
0%
Device related bacteraemia
0%
Pancreatitis
0%
Abdominal distension
0%
COVID-19
0%
Staphylococcal sepsis
0%
Subdiaphragmatic abscess
0%
Lumbar vertebral fracture
0%
Neoplasm prostate
0%
Chronic kidney disease
0%
Hallucination
0%
Deep vein thrombosis
0%
Large intestine perforation
0%
Confusional state
0%
Cardiomyopathy
0%
Left ventricular dysfunction
0%
Myocardial infarction
0%
Cholecystitis
0%
Drug-induced liver injury
0%
Hypersensitivity
0%
Bacterial sepsis
0%
Clostridium bacteraemia
0%
Diarrhoea infectious
0%
Pseudomonal sepsis
0%
Blood lactate dehydrogenase increased
0%
Sudden death
0%
General physical health deterioration
0%
Otitis media acute
0%
Pneumonia staphylococcal
0%
Subdural haemorrhage
0%
Partial seizures
0%
Somnolence
0%
Renal failure
0%
Gastrointestinal perforation
0%
Inguinal hernia
0%
Graft versus host disease
0%
Spinal fracture
0%
Glossitis
0%
Ileus
0%
C-reactive protein increased
0%
Oral infection
0%
Haemorrhoidal haemorrhage
0%
Cardiac failure congestive
0%
Hepatitis
0%
Candida pneumonia
0%
Diverticulitis
0%
Metabolic encephalopathy
0%
Ventricular fibrillation
0%
Enterobacter bacteraemia
0%
Cardiac failure
0%
Epilepsy
0%
Colitis
0%
Cholecystitis acute
0%
Diverticulum intestinal haemorrhagic
0%
Rectal haemorrhage
0%
Perirectal abscess
0%
Multiple organ dysfunction syndrome
0%
Intestinal haemorrhage
0%
Intracardiac mass
0%
Myocardial ischaemia
0%
Vision blurred
0%
Enteritis
0%
Lower respiratory tract infection
0%
Lower respiratory tract infection bacterial
0%
Skin infection
0%
Systemic infection
0%
Systemic mycosis
0%
Femoral neck fracture
0%
Hip fracture
0%
Lung infiltration
0%
Soft tissue inflammation
0%
Cholangitis acute
0%
Anal abscess
0%
Intra-abdominal haematoma
0%
Bile duct stone
0%
Abscess
0%
Bronchitis
0%
COVID-19 pneumonia
0%
Cytokine release syndrome
0%
Candida sepsis
0%
Catheter site infection
0%
Influenza
0%
Infected skin ulcer
0%
Liver abscess
0%
Periodontitis
0%
Klebsiella bacteraemia
0%
Pharyngitis
0%
Post procedural infection
0%
Pyelonephritis acute
0%
Rectal abscess
0%
Post procedural complication
0%
Subdural haematoma
0%
Electroencephalogram abnormal
0%
Hyperkalaemia
0%
Creatinine renal clearance decreased
0%
Transfusion reaction
0%
SARS-CoV-2 test positive
0%
Failure to thrive
0%
Osteoarthritis
0%
Encephalopathy
0%
Gastrointestinal neoplasm
0%
Neoplasm progression
0%
Cerebrovascular accident
0%
Intracranial aneurysm
0%
Urinary retention
0%
Pneumonitis
0%
Dermatitis exfoliative generalised
0%
Pneumonia aspiration
0%
Pneumothorax
0%
Pulmonary oedema
0%
Drug eruption
0%
Peripheral ischaemia
0%
Thrombophlebitis superficial
0%
Venous thrombosis
0%
Bradycardia
0%
Aneurysm ruptured
0%
Axillary vein thrombosis
0%
Circulatory collapse
0%
Hypovolaemic shock
0%
Thrombosis
0%
This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT03416179) in the Intensive Study: Glasdegib + Cytarabine + Daunorubicin ARM group. Side effects include: Nausea with 56%, Anaemia with 51%, Febrile neutropenia with 49%, Diarrhoea with 48%, Pyrexia with 42%.

Trial Design

1 Treatment Group

AZA
1 of 1
Experimental Treatment

This trial requires 43 total participants across 1 different treatment group

This trial involves a single treatment. Azacitidine is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

AZA
Drug
azacitidine
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: one year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly one year for reporting.

Who is running the study

Principal Investigator
S. F.
Shatha Farhan, Principal Investigator
Henry Ford Health System

Closest Location

Henry ford hospital - Detroit, MI

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Cancer or the other condition listed above. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients with AML/MDS/MPN, CMML post Allogeneic SCT who experience any drop in total or myeloid chimerism any time after day 30, or their day 30 or day100 myeloid donor chimerism is below 98% without concurrent hematologic relapse (that is, patients with <5% bone marrow blasts as obtained at that time point) will be offered treatment with azacitidine
>=30 -180 days post SCT and patients must have ANC> 1000, PLT > 50,000
Age 18-75 years old
Performance score of at least 70% by Karnofsky
Creatinine clearance should be >60 ml/min
Total Bilirubin <1.5, ALT/AST/Alk Phos < 2.5 x normal. No evidence of chronic active hepatitis or cirrhosis.
Negative Beta HCG test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. Women of child bearing potential must be willing to use an effective contraceptive measure while on study.
Patient or patient's legal representative, parent(s) or guardian able to sign informed consent.
Patients must be off any prior chemotherapy, radiotherapy, or other investigational therapy within 2 weeks prior to start treatment

Patient Q&A Section

Does azacitidine improve quality of life for those with cancer?

"Azacitidine was well tolerated but did not improve QoL in cancer patients enrolled in the current trial. Future studies are needed to establish its effect and to better understand the role of azacitidine in cancer patients." - Anonymous Online Contributor

Unverified Answer

What causes cancer?

"Cancer is a disease of many different etiologies, but there is also a clear link between lifestyle and cancer, including smoking, excess alcohol consumption and obesity. People who have had cancer are at increased risk of subsequent disease. Vaccinations, hygiene and food are also important. Some cancers such as liver cancer are linked to excessive alcohol use, and smoking is a significant risk factor for lung cancer and lung diseases. The link between smoking and oral cancers is particularly strong." - Anonymous Online Contributor

Unverified Answer

What is cancer?

"In most cancers, cells divide uncontrollably and form an aggressive tumor. Because cancer cells are normally present in the skin, the diagnosis of cancer should be considered when lesions change, especially when these seem to be more frequent than is normal. Cancer is a disease involving abnormal cell growth that threatens the body. It can spread to other parts of the body. Most cancers are caused by inherited genetic abnormalities in DNA, and most of these have been found by cancer genetics. Some cancers are caused by environmental exposures or lifestyle factors." - Anonymous Online Contributor

Unverified Answer

What are common treatments for cancer?

"Treatment options for cancer are extensive and may be classified according to the type of cancer or how advanced it is, such as surgery, chemo, radiation, or hormonal manipulation or antibody therapy. For advanced cancers, treatments may include cryo, chemo, radiation, and hormonal manipulation. For cancers on early detection, treatments may range from the use of preventive techniques such as screening to surgery and chemo. For all cancers, an ongoing discussion exists regarding individualized treatment approaches." - Anonymous Online Contributor

Unverified Answer

Can cancer be cured?

"Current treatments do not make long-term cure possible. However, there is an increasing proportion of patients surviving and remaining cancer-free for prolonged periods of time, and these patients can live without treatments and remain in remission. Thus, we cannot say that cancer cannot be cured." - Anonymous Online Contributor

Unverified Answer

What are the signs of cancer?

"Signs of cancer can often be identified with a good clinical history. When there are no other obvious signs of cancer, a CT with contrast can be helpful in confirming whether there is a mass, and what else may be needed like surgery or chemotherapy." - Anonymous Online Contributor

Unverified Answer

How many people get cancer a year in the United States?

"Around 2.9 million new cases of cancer will be diagnosed in the United States in 2007. Over 40% of these will be related to a modifiable risk factors. If one in 10 deaths in the United States is due to a modifiable risk, then around 890,000 will die from cancer that year, most of whom die from modifiable causes. Because the risk factors for cancer are highly modifiable, early diagnosis is paramount." - Anonymous Online Contributor

Unverified Answer

How does azacitidine work?

"Azacitidine causes myelodysplasia, which is a type of cancer, to be more manageable and hopefully, this effect will eventually help people with an earlier stage of the disease. The myelodysplastic syndrome is a type of anemia. It is used in people who don't get results from being given blood transfusion.\n" - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets cancer?

"Cancer of the pancreas occurs in almost 3 times more men than women, although both genders have more than 5 times increased incidence of cancer with age. The median age of diagnosis (incidence) of pancreatic cancer was 73 years for men (40.0% of cases) and 81 years for women (45.7%)." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of cancer?

"Findings from a recent study has revealed the primary cause of cancer. It has been made clear that the cause of cancer in Africa, Asia, and America could be different from other continents as a result of environmental factors and socioeconomic situation." - Anonymous Online Contributor

Unverified Answer

Is azacitidine safe for people?

"Intravenous azacitidine at 150 or 300 mg in the first week of three cycles reduces haematological toxicity and results in a good quality of life. However, myelosuppression occurs and is more frequent during the first two cycles. To minimize this risk, caution is required during the first and the second cycle when starting and switching to azacitidine." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for cancer?

"Clinical trials are a great source of clinical knowledge but can also be a source of patient burden. Clinicians should consider addressing this issue in order to improve compliance with current clinical trial regulations, and also to enable more comprehensive informed consent." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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