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Anti-metabolites
Azacitidine + Nivolumab/Midostaurin vs. Decitabine/Cytarabine for Acute Myeloid Leukemia
Phase 2 & 3
Waitlist Available
Led By Laura C Michaelis
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must be able to swallow oral medications without crushing or chewing
Patients must have morphologically confirmed, previously untreated acute myeloid leukemia (AML) or MDS with excess blasts-2 (MDS-EB-2)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying azacitidine with or without nivolumab or midostaurin, or decitabine and cytarabine alone to see how well they work compared to each other in treating patients with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome.
Who is the study for?
This trial is for older adults with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome. Participants must not need concurrent cancer therapy (except hormonal), have acceptable liver function, be able to swallow pills, and consent to specimen banking. Women of childbearing age and sexually active men must use effective contraception. Those with central nervous system leukemia, prior specific treatments like midostaurin or DNA-methyltransferase inhibitors, or who are pregnant/nursing are excluded.Check my eligibility
What is being tested?
The study compares the effectiveness of azacitidine alone versus in combination with nivolumab (an immunotherapy) or midostaurin (a growth blocker), against decitabine and cytarabine alone in treating certain blood cancers. It aims to determine which treatment stops cancer cells from growing by either killing them directly or boosting the immune response against them.See study design
What are the potential side effects?
Potential side effects include reactions related to chemotherapy such as nausea, fatigue, low blood counts leading to increased infection risk; immunotherapy may cause autoimmune-like conditions where the body attacks its own cells; midostaurin can lead to gastrointestinal symptoms and potential heart rhythm abnormalities.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can swallow pills without needing to crush or chew them.
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I have been diagnosed with AML or MDS-EB-2 and have not received treatment.
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My cancer is in my blood or bone marrow, not just in other body parts.
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I am eligible for at least one of the treatment options S1612B or S1612C.
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I am suspected to have AML or MDS-EB-2 without prior treatment.
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I do not have an ongoing infection that isn't getting better with treatment.
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I haven't needed treatment for an autoimmune disease in the last 2 years.
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I have not had treatments with midostaurin, anti-PD-1/L1, DNA-methyltransferase inhibitors, or intensive therapy for MDS.
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I do not have APL, biphenotypic leukemia, or blastic transformation of CML.
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I do not have acute myeloid leukemia in my brain or spinal cord.
Select...
I do not have leukemia in my brain or spinal cord.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
OS (Phase III)
Overall survival (OS) (Phase II)
Other outcome measures
Cumulative incidence of relapse defined as achieving CR or CRi
Cytogenetic abnormalities, risk categories, and mutations in bone marrow
Event-free survival (EFS)
+6 moreSide effects data
From 2007 Phase 3 trial • 358 Patients • NCT0007179967%
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%
Myocardial infarction
1%
Mouth haemorrhage
1%
Subileus
1%
Endophthalmitis
1%
Tooth disorder
1%
Salmonella sepsis
1%
Haemorrhoidal haemorrhage
1%
Hypophosphataemia
1%
Haematemesis
1%
Blood lactate dehydrogenase increased
1%
Fungal skin infection
1%
Joint swelling
1%
Gastrointestinal haemorrhage
1%
Angle closure glaucoma
1%
Intestinal haemorrhage
1%
Angina pectoris
1%
Strabismus
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%
Benign prostatic hyperplasia
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
4Treatment groups
Experimental Treatment
Active Control
Group I: Arm D (decitabine, cytarabine)Experimental Treatment3 Interventions
INDUCTION: Patients receive decitabine IV over 2 hours on days 1-5 and cytarabine IV continuously on days 6-11. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Patients deemed stable at the discretion of the treating physician receive decitabine as in Induction. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm C (azacitidine, midostaurin)Experimental Treatment3 Interventions
Patients receive azacitidine as in Arm A and midostaurin orally (PO) twice daily (BID) on days 8-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group III: Arm B (azacitidine, nivolumab)Experimental Treatment3 Interventions
Patients receive azacitidine as in Arm A and nivolumab IV over 30-60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group IV: Arm A (azacitidine)Active Control2 Interventions
Patients receive azacitidine SC or IV daily on days 1-7 or on an interrupted schedule which ensures that all 7 days of therapy are received within a 12 day period. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Midostaurin
2018
Completed Phase 3
~1640
Nivolumab
2014
Completed Phase 3
~4750
Azacitidine
2012
Completed Phase 3
~1440
Decitabine
2004
Completed Phase 3
~1680
Cytarabine
2016
Completed Phase 3
~3310
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,075 Total Patients Enrolled
Laura C MichaelisPrincipal InvestigatorSWOG Cancer Research Network
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there a wealth of research on Azacitidine?
"There are a total of 1232 ongoing clinical trials researching azacitidine with 180 of them being in phase 3. Many of these trials are located in Hong Kong and Maryland, but there are 54752 clinical trial sites for azacitidine across the world."
Answered by AI
Are new test subjects being accepted into this experiment currently?
"This particular trial is no longer recruiting patients. The trial was posted on December 22nd, 2017 and was last updated on September 23rd, 2022. There are presently 2912 studies actively recruiting patients with myelodysplastic syndromes and 1232 trials for Azacitidine that are looking for participants."
Answered by AI
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