← Back to Search

DNA Methyltransferase Inhibitor

Triple-Drug Therapy for Acute Myeloid Leukemia

Phase 1 & 2
Waitlist Available
Led By Naval G Daver
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of AML (excluding acute promyelocytic leukemia [APL])
Females must be surgically or biologically sterile or postmenopausal (amenorrheic for at least 12 months) or if of childbearing potential, must have a negative serum or urine pregnancy test within 72 hours before the start of the treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 3 months of treatment initiation
Awards & highlights

Study Summary

This trial is testing magrolimab, azacitidine, and venetoclax to treat acute myeloid leukemia. Magrolimab is an antibody that may stop cancer cells from growing. Azacitidine and venetoclax are chemotherapy drugs that work in different ways to stop the growth of cancer cells. Giving all three drugs may help to control the disease.

Who is the study for?
Adults with acute myeloid leukemia (AML) who are either newly diagnosed with poor risk factors or have relapsed/refractory AML after previous treatments. Participants must be fit enough for the trial, not eligible for intensive chemotherapy due to age/comorbidities, and should not have uncontrolled diseases or known allergies to the drugs being tested.Check my eligibility
What is being tested?
The trial is testing a combination of magrolimab, azacitidine, and venetoclax in patients with AML. Magrolimab is an antibody that may stop cancer growth; azacitidine interferes with cell division; venetoclax blocks proteins needed by cancer cells.See study design
What are the potential side effects?
Potential side effects include immune reactions from magrolimab, blood count changes from azacitidine, and gastrointestinal symptoms or fatigue from venetoclax. The severity can vary among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with AML, not including APL.
Select...
I am not able to have children, am postmenopausal, or have a negative pregnancy test.
Select...
My kidney function, measured by creatinine clearance, is adequate.
Select...
I am 18 or older with a specific type of high-risk AML.
Select...
I am 75 or older with new AML and can't have strong chemotherapy due to my age or health issues.
Select...
I am 18 or older with AML that has come back or didn’t respond to treatment, and I can't or won't undergo potentially curative therapy but have had at least one prior treatment.
Select...
I can take care of myself but might not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 3 months of treatment initiation
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 3 months of treatment initiation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Duration of response (phase II)
Event-free survival (phase II)
Incidence of adverse events (phase II)
+3 more
Secondary outcome measures
Change in clinical variables (phase II)
Change in gene expression (phase II)

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%
Pneumonia
11%
Febrile neutropenia
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%
Mouth ulceration
5%
Chest pain
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%
Stomatitis
3%
Productive cough
3%
Tachycardia
3%
Respiratory tract infection
3%
Dry mouth
3%
Gingivitis
3%
Chills
3%
Sinusitis
3%
Sepsis
3%
Fall
3%
Alanine aminotransferase increased
3%
Sleep disorder
2%
Catheter site haematoma
2%
Hyperuricaemia
2%
Muscular weakness
2%
Nasal congestion
2%
Neutropenic sepsis
2%
Gastritis
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%
Catheter site pain
1%
Tooth abscess
1%
Blood lactate dehydrogenase increased
1%
Musculoskeletal chest pain
1%
Oral soft tissue disorder
1%
Joint swelling
1%
Benign prostatic hyperplasia
1%
Abdominal discomfort
1%
Intestinal haemorrhage
1%
Tooth disorder
1%
Herpes zoster
1%
Meningitis
1%
Enterobacter infection
1%
Gastrointestinal haemorrhage
1%
Hypophosphataemia
1%
Subileus
1%
Lung infection
1%
Clostridium difficile colitis
1%
Endophthalmitis
1%
Atrial fibrillation
1%
Perianal abscess
1%
Haematemesis
1%
Psychotic disorder
1%
Strabismus
1%
Angle closure glaucoma
1%
Eye Haemorrhage
1%
Pancytopenia
1%
Angina pectoris
1%
Myocardial infarction
1%
Haemorrhoidal haemorrhage
1%
Ventricular tachycardia
1%
Transient ischaemic attack
1%
Food poisoning
1%
Subdiaphragmatic abscess
1%
Mouth haemorrhage
1%
Corynebacterium infection
1%
Renal colic
1%
Cellulitis
1%
Subcutaneous abscess
1%
Confusional state
1%
Delirium
1%
Anal haemorrhage
1%
Conjunctivitis
1%
Ocular hyperaemia
1%
Gastrointestinal pain
1%
Catheter site haemorrhage
1%
Fungal skin infection
1%
Hypoxia
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%
Salmonella sepsis
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%
Peripheral vascular disorder
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: Treatment (azacitidine, venetoclax, magrolimab)Experimental Treatment3 Interventions
Patients receive azacitidine SC or IV over 30-60 minutes on days 1-7, venetoclax PO QD on days 1-28 of cycle 1 (may be reduced to days 1-21 for subsequent cycles after principal investigator approval), and magrolimab IV over 2-3 hours on days 1, 4, 8, 11, 15, and 22 of cycle 1, days 1, 8, 15, and 22 of cycle 2, and days 1 and 15 of cycle 3 and subsequent cycles. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
2012
Completed Phase 3
~1440
Venetoclax
2019
Completed Phase 3
~1990
Magrolimab
2018
Completed Phase 2
~120

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,536 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,339 Total Patients Enrolled
Naval G DaverPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
75 Total Patients Enrolled

Media Library

Azacitidine (DNA Methyltransferase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04435691 — Phase 1 & 2
Acute Myeloid Leukemia Research Study Groups: Treatment (azacitidine, venetoclax, magrolimab)
Acute Myeloid Leukemia Clinical Trial 2023: Azacitidine Highlights & Side Effects. Trial Name: NCT04435691 — Phase 1 & 2
Azacitidine (DNA Methyltransferase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04435691 — Phase 1 & 2

Frequently Asked Questions

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

Are there any open vacancies for individuals to take part in this research program?

"Affirmative. Based on the information available on clinicaltrials.gov, this medical study is actively searching for participants. Initially posted on July 28th 2020 and most recently updated March 8th 2023, the research requires 98 patients to be recruited from a single location."

Answered by AI

What therapeutic benefits does Azacitidine offer?

"Azacitidine is commonly used to treat induction chemotherapy, however it may also be beneficial for refractory anemias, acute myeloid leukemia and multi-lineage dysplasia."

Answered by AI

Are there any previous investigations involving the drug Azacitidine?

"Presently, 340 trials researching Azacitidine are ongoing with 52 of them in their terminal phase. While a majority of these clinical investigations are conducted in Edmonton, Alberta, there is also activity across the globe at 11923 sites."

Answered by AI

How many participants are included in the evaluation of this clinical trial?

"Affirmative. The records on clinicaltrials.gov state that this research is actively seeking participants, having been first unveiled on July 28th 2020 and recently updated on March 8th 2023. Currently, the project requires 98 volunteers across 1 location."

Answered by AI
~19 spots leftby Dec 2024