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DNA Methyltransferase Inhibitor
Venetoclax + Azacitidine for Myeloproliferative Disorders
Phase 2
Recruiting
Led By Vikas Gupta, M.D.
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented diagnosis per World Health Organization (WHO) 2016 criteria of BCR-ABL negative myeloproliferative neoplasms (MPN)
Female participants of childbearing potential must have a negative serum pregnancy test within 14 days prior to cycle 1 day 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial will study the safety and efficacy of azacitidine and venetoclax in people with BRC-ABL negative myeloproliferative neoplasms.
Who is the study for?
This trial is for adults with advanced BCR-ABL negative myeloproliferative neoplasms who haven't had blast reduction therapy for their condition. They should be able to perform daily activities with ease to moderate difficulty (ECOG 0-2) and have good organ function. Participants must not be pregnant, breastfeeding, or have a recent history of other cancers or serious health conditions that could affect study participation.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of combining two drugs, Venetoclax and Azacitidine, in treating accelerated or blast phase myeloproliferative neoplasms. It aims to understand how well these drugs work together for patients who haven't received prior treatment specifically aimed at reducing blasts in their blood.See study design
What are the potential side effects?
Potential side effects may include nausea, vomiting, diarrhea, low blood counts leading to increased infection risk or bleeding problems, fatigue, liver issues and potential drug interactions affecting heart rhythm or other medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood disorder diagnosis follows WHO 2016 criteria and is not caused by the BCR-ABL gene.
Select...
I am a woman who can have children and have a negative pregnancy test within the last 14 days.
Select...
My organs are working well.
Select...
I am able to get out of my bed or chair and move around.
Select...
My blood disorder has worsened without having received specific treatment for this advanced stage.
Select...
I can sign the consent form on my own.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of participants achieving complete remission (CR).
Proportion of participants achieving complete remission with incomplete hematologic recovery (CRi).
Proportion of participants achieving reversion to chronic myeloproliferative neoplasm (CMPN).
Secondary outcome measures
Average number of days from CMPN until relapse.
Average number of days from CR until relapse.
Average number of days from CRi until relapse.
+2 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%
Strabismus
1%
Gastrointestinal haemorrhage
1%
Haematemesis
1%
Mouth haemorrhage
1%
Endophthalmitis
1%
Tooth disorder
1%
Salmonella sepsis
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%
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
1Treatment groups
Experimental Treatment
Group I: Azacitidine and VenetoclaxExperimental Treatment2 Interventions
A treatment cycle is 28 days long.
Azacitidine will be given by injection under the skin, once a day, for the first 6 days of every cycle.
Venetoclax will be given orally, once a day, as follows at the discretion of their study doctors:
Cycle 1:
Day 1 - 100 mg
Day 2 - 200 mg
Days 3 to 28 - 400 mg
Cycle 2:
Participants with a response to the study drugs will continue taking 400 mg from Days 1 to 21, with no study drug from Days 22 to 28 during Cycle 2.
Participants who have not yet responded to the study drugs will continue taking 400 mg from Days 1 to 28 during Cycle 2.
Cycle 3 and subsequent cycles:
Participants with a response to the study drugs will continue to take 400 mg from Days 1 to 21, with no study drug from Days 22 to 28.
Participants whose disease has not worsened will continue taking 400 mg from Days 1 to 28.
Participants have not responded to the study drugs will be withdrawn from the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1990
Azacitidine
2012
Completed Phase 3
~1440
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,468 Previous Clinical Trials
484,450 Total Patients Enrolled
Vikas Gupta, M.D.Principal InvestigatorPrincess Margaret Cancer Centre
2 Previous Clinical Trials
93 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a stem cell transplant from a donor for my blood disorder.My blood disorder diagnosis follows WHO 2016 criteria and is not caused by the BCR-ABL gene.I have had treatment to reduce blood cell precursors for myeloproliferative neoplasm.I am a woman who can have children and have a negative pregnancy test within the last 14 days.My leukemia has spread to my brain or spinal cord.I have an infection that isn't getting better despite treatment.I haven't taken strong or moderate CYP3A inducers in the last 7 days.My organs are working well.I am able to get out of my bed or chair and move around.My blood disorder has worsened without having received specific treatment for this advanced stage.You have a mental health condition, difficult life circumstances, or other serious health problems that could make it hard for you to take part in the study.I have a history of MDS, CMML, or other related blood disorders.I do not have active HIV, HBV, or HCV infections.My cancer has a specific genetic feature (t 15;17).I can sign the consent form on my own.I have had a heart attack in the last 3 months.I currently have an active COVID-19 infection.I have not had any active cancer in the last 2 years.I have been treated with venetoclax, navitoclax, azacytidine, or similar drugs.
Research Study Groups:
This trial has the following groups:- Group 1: Azacitidine and Venetoclax
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants being recruited for this medical experiment?
"At this moment in time, the clinical trial is not recruiting participants. Noticeably, it was initial posted on May 16th 2022 and last updated April 12th of that same year. However, if you're looking for other medical studies there are currently 2441 trials searching for individuals with bcr-abl negative and 340 ones involving azacitidine actively seeking patients."
Answered by AI
How many participants have been recruited for this research endeavor?
"Unfortunately this trial is no longer seeking out participants. Initially posted on May 16 2022, the last update was made to the study page on April 12th of that same year. If you are looking into other studies, there are currently 2441 trials recruiting bcr-abl negative patients and 340 for Azacitidine available right now."
Answered by AI
Is Azacitidine a low-risk medication for individuals?
"Azacitidine's safety has been partially established in Phase 2 trials, warranting a score of two. No studies have yet demonstrated the drug's efficacy."
Answered by AI
What medical conditions can be aided by the administration of Azacitidine?
"Azacitidine is commonly used to induce chemotherapy, and can also be employed in treating refractory anemias, leukemia, myelocytic conditions, acute dysplasia, and multilineage illnesses."
Answered by AI
What other trials have been conducted with Azacitidine as the primary agent?
"Presently, 340 clinical trials involving Azacitidine are ongoing in 11189 locations worldwide. 54 of these studies have entered the third phase. Notably, several of those experiments are based in Edmonton, Alberta."
Answered by AI
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