← Back to Search

Azacitidine for Myeloid Leukemia After Stem Cell Transplant

Phase 2
Recruiting
Research Sponsored by Henry Ford Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Patients must be off any prior chemotherapy, radiotherapy, or other investigational therapy within 2 weeks prior to start treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights

Study Summary

This trial is testing whether a drug called azacitidine is safe and effective in people who have received a stem cell transplant from a donor.

Who is the study for?
This trial is for adults aged 18-75 with AML/MDS/MPN, CMML who've had a stem cell transplant and show any drop in donor chimerism. They must have stable blood counts, no severe GVHD or active infections, not be pregnant, agree to use contraception if capable of childbearing, and have good organ function.Check my eligibility
What is being tested?
The study tests azacitidine's ability to maintain donor chimerism after an allogeneic stem cell transplant in patients with certain myeloid cancers. The goal is to reduce cancer relapse without increasing graft versus host disease by administering azacitidine between day 30 and day 180 post-transplant.See study design
What are the potential side effects?
Azacitidine may cause side effects like nausea, vomiting, low blood counts leading to increased infection risk or bleeding problems. It can also potentially worsen graft versus host disease symptoms in some patients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I had a stem cell transplant and my recovery markers are within the required range.
Select...
I haven't had chemotherapy, radiotherapy, or experimental treatments in the last 2 weeks.
Select...
I am a woman who can have children, have a negative pregnancy test, and will use birth control during the study.
Select...
I am between 18 and 75 years old.
Select...
I can care for myself but cannot do normal activities or work.
Select...
My kidney and liver are functioning well, with no chronic hepatitis or cirrhosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The rate of increase or stable donor chimerism

Side effects data

From 2022 Phase 3 trial • 730 Patients • NCT03416179
56%
Nausea
51%
Anaemia
49%
Febrile neutropenia
48%
Diarrhoea
42%
Pyrexia
39%
Platelet count decreased
38%
Hypokalaemia
36%
Constipation
32%
White blood cell count decreased
29%
Vomiting
28%
Neutrophil count decreased
26%
Thrombocytopenia
26%
Decreased appetite
23%
Rash
21%
Neutropenia
21%
Hypophosphataemia
20%
Alanine aminotransferase increased
20%
Dysgeusia
20%
Headache
16%
Fatigue
16%
Abdominal pain
16%
Pneumonia
16%
Hypoalbuminaemia
15%
Stomatitis
15%
Hypomagnesaemia
15%
Aspartate aminotransferase increased
14%
Insomnia
13%
Oedema peripheral
13%
Hypocalcaemia
13%
Blood bilirubin increased
12%
Hyponatraemia
12%
Dizziness
12%
Cough
11%
Electrocardiogram QT prolonged
11%
Weight decreased
11%
Back pain
11%
Rash maculo-papular
11%
Alopecia
10%
Muscle spasms
10%
Lymphocyte count decreased
10%
Oropharyngeal pain
10%
Chills
10%
Epistaxis
9%
Arthralgia
9%
Hypotension
9%
Blood creatinine increased
8%
Bacteraemia
8%
Dyspnoea
8%
Asthenia
8%
Myalgia
8%
Sepsis
7%
Haemorrhoids
7%
Blood alkaline phosphatase increased
7%
Proctalgia
7%
Hyperuricaemia
7%
Non-cardiac chest pain
7%
Dry skin
6%
Gamma-glutamyltransferase increased
6%
Pruritus
6%
Abdominal pain upper
6%
Dyspepsia
6%
Mucosal inflammation
6%
Sinus tachycardia
6%
Paraesthesia
5%
Oedema
5%
Leukopenia
5%
Upper respiratory tract infection
5%
Hyperglycaemia
5%
Hypertension
4%
Petechiae
3%
Urinary tract infection
2%
Atrial fibrillation
2%
Gastrointestinal haemorrhage
2%
Infection
2%
Pseudomonal bacteraemia
1%
Groin abscess
1%
Cardiac arrest
1%
Cardiac failure acute
1%
Myocarditis
1%
Lower gastrointestinal haemorrhage
1%
Bronchopulmonary aspergillosis
1%
Cellulitis
1%
Clostridium difficile colitis
1%
Escherichia bacteraemia
1%
Pseudomembranous colitis
1%
Soft tissue infection
1%
Fall
1%
Syncope
1%
Acute kidney injury
1%
Acute myocardial infarction
1%
Anal fistula
1%
Enterocolitis
1%
Gastric ulcer
1%
Intussusception
1%
Small intestinal haemorrhage
1%
Cholelithiasis
1%
Graft versus host disease in skin
1%
Clostridium colitis
1%
Fungal infection
1%
Pulmonary tuberculosis
1%
Urethritis
1%
Cerebral haemorrhage
1%
Adjustment disorder with depressed mood
1%
Acute respiratory distress syndrome
1%
Acute respiratory failure
1%
Erythema
1%
Orthostatic hypotension
1%
Enterococcal bacteraemia
1%
Pneumonia fungal
1%
Leukocytosis
1%
Splenic necrosis
1%
Upper gastrointestinal haemorrhage
1%
Neutropenic sepsis
1%
Haemorrhage intracranial
1%
Escherichia sepsis
1%
Herpes ophthalmic
1%
Pulmonary haemorrhage
1%
Septic shock
1%
Peritonitis
1%
Disease progression
1%
Malaise
1%
Graft versus host disease in gastrointestinal tract
1%
Clostridial sepsis
1%
Hypoxia
1%
Hyperbilirubinaemia
1%
Arthritis infective
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intensive Study: Glasdegib + Cytarabine + Daunorubicin
Intensive Study: Placebo + Cytarabine + Daunorubicin
Non-intensive Study: Glasdegib + Azacitidine
Non-intensive Study: Placebo + Azacitidine

Trial Design

1Treatment groups
Experimental Treatment
Group I: AZAExperimental Treatment1 Intervention
azacitidine
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
azacitidine
2005
Completed Phase 3
~1740

Find a Location

Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor
299 Previous Clinical Trials
2,098,704 Total Patients Enrolled

Media Library

azacitidine Clinical Trial Eligibility Overview. Trial Name: NCT03850418 — Phase 2
Myeloid Leukemia Research Study Groups: AZA
Myeloid Leukemia Clinical Trial 2023: azacitidine Highlights & Side Effects. Trial Name: NCT03850418 — Phase 2
azacitidine 2023 Treatment Timeline for Medical Study. Trial Name: NCT03850418 — Phase 2

Frequently Asked Questions

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

Is my profile suitable for enrolment in this research trial?

"This trial is recruiting 43 persons aged 18 to 75, who have been diagnosed with cancer and fulfill the following conditions: AML/MDS/MPN, CMML post Allogeneic SCT experiencing a decrease in total or myeloid chimerism at any time after day 30; ANC> 1000; PLT > 50,000; performance score of 70% by Karnofsky; creatinine clearance higher than 60 ml/min.; total bilirubin <1.5; ALT/AST/Alk Phos < 2.5 x normal without chronic active hepatitis or cirrhosis signs; negative Beta"

Answered by AI

Is this exploratory research open to individuals older than 45?

"Candidates eligible for this trial must be aged 18 to 75. In contrast, there are 317 trials available to those below the age of consent and 2363 clinical studies open to participants over 65 years old."

Answered by AI

To which medical conditions is azacitidine typically prescribed?

"Azacitidine is usually prescribed for malignant neoplasms, although it can also be employed to address cases of 20-30% blasts, neutropenia and/or thrombocytopenia, as well as anemia."

Answered by AI

Have any other investigations been conducted utilizing azacitidine?

"Currently, there are 174 azacitidine clinical trials running with 32 of them being Phase 3. With most studies taking place in Saint Louis, Missouri, the total number of locations trialling this medication is 5671."

Answered by AI

Are recruitment efforts still underway for this investigation?

"According to the clinicaltrials.gov, this medical experiment is actively recruiting volunteers. The trial was initially advertised on July 1st 2019 and recently revised December 23rd 2021."

Answered by AI

Has the azacitidine molecule received regulatory endorsement from the FDA?

"There is a moderate amount of evidence for azacitidine's safety, so it was allocated a score of 2."

Answered by AI

How many participants is the clinical trial currently accommodating?

"Affirmative. Clinicaltrials.gov reveals that the trial, first published on July 1st 2019, is actively recruiting and seeking 43 participants to be enrolled at a single location."

Answered by AI
~6 spots leftby Feb 2025