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DNA Methyltransferase Inhibitor
Venetoclax + Azacitidine for Myelodysplastic Syndrome
Phase 2
Recruiting
Led By Uma M Borate, MD
Research Sponsored by Uma Borate
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Previously untreated therapy related myelodysplastic syndrome (t-MDS) with Revised International Prognostic Scoring System (IPSS-R) risk categories Intermediate, High or Very High (i.e., minimum IPSS-R score of 3.5) and presence of < 20% bone marrow blasts per bone marrow biopsy/aspirate
Patients with t-MDS which is defined as patients who have had prior anti-cancer therapy including chemotherapy and/or radiation therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of study follow-up period (24 months after last dose of study drug)
Awards & highlights
Study Summary
This trial is studying the effects of two different drugs on patients with myelodysplastic syndrome. Venetoclax may stop the growth of cancer cells by blocking a protein needed for cancer cell survival, while azacitidine works in different ways to stop the growth of cancer cells. The combination of these two drugs may be more effective in treating patients with myelodysplastic syndrome.
Who is the study for?
Adults with untreated therapy-related myelodysplastic syndrome (t-MDS) and a specific risk score, who can consent to the study. They must have good organ function, not be pregnant or breastfeeding, agree to contraception if of childbearing potential, and not have certain heart conditions or uncontrolled illnesses. Prior cancer treatments are allowed except for venetoclax.Check my eligibility
What is being tested?
The trial is testing the combination of Venetoclax and Azacitidine in patients with t-MDS. Venetoclax targets proteins that help cancer cells survive while Azacitidine interferes with cell growth. The trial includes questionnaires and quality-of-life assessments to evaluate effectiveness.See study design
What are the potential side effects?
Potential side effects include nausea, vomiting, diarrhea, low blood counts leading to increased infection risk or bleeding problems, fatigue, liver issues like elevated enzymes or bilirubin levels which could indicate liver damage.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My MDS is untreated, has a high risk score, and less than 20% bone marrow blasts.
Select...
I have MDS caused by previous cancer treatments.
Select...
My kidney function, measured by creatinine clearance, is normal or near normal.
Select...
I can take care of myself but might not be able to do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ end of study follow-up period (24 months after last dose of study drug)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of study follow-up period (24 months after last dose of study drug)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete remission (CR)
Secondary outcome measures
Cytogenetic response rate (CCyR)
Duration of response (DOR)
Event free survival (EFS)
+9 moreOther outcome measures
Biometric measures recorded by the FitBit (e.g., heart rate, number of steps taken, activity time, calories burned)
Detection of cytogenetic abnormalities
Patient-reported outcomes (PROs)
Side 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%
Endophthalmitis
1%
Strabismus
1%
Haematemesis
1%
Mouth haemorrhage
1%
Gastrointestinal haemorrhage
1%
Salmonella sepsis
1%
Myocardial infarction
1%
Benign prostatic hyperplasia
1%
Tooth disorder
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%
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: Treatment (venetoclax, azacitidine)Experimental Treatment4 Interventions
Patients receive venetoclax PO QD on days 1-14 and azacitidine IV over 10-40 minutes on days 1-7 or days 1-5 of week 1 and days 1 and 2 of week 2. Cycles 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
Venetoclax
2019
Completed Phase 3
~1990
Azacitidine
2012
Completed Phase 3
~1440
Find a Location
Who is running the clinical trial?
Uma BorateLead Sponsor
5 Previous Clinical Trials
192 Total Patients Enrolled
Uma M Borate, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to use or have my partner use two forms of birth control and not donate sperm until 90 days after my last treatment dose.I have been treated with venetoclax or similar drugs before.I have not received a live vaccine in the last 4 weeks.My condition is a specific type of blood disorder not initially treated and I am open to intensive treatment or a stem cell transplant.My prostate cancer has not spread and doesn't need treatment right now.I agree to use birth control or abstain from sex during and 30 days after the study.I cannot take medicine by mouth due to a digestive condition.My MDS is untreated, has a high risk score, and less than 20% bone marrow blasts.I have had a bone marrow or organ transplant.I have not taken strong or moderate CYP3A inducers in the last week.My cervical cancer was treated while still in its early stages.I have tested positive for HIV, Hepatitis B, or Hepatitis C.I have had successful treatment for a type of skin cancer.I have MDS caused by previous cancer treatments.I am 18 years or older and have given my consent to participate.I do not have serious heart problems or recent heart attacks.I have taken strong or moderate CYP3A inhibitors within the last week.I do not have any ongoing infections, pneumonia, or febrile neutropenia.My kidney function, measured by creatinine clearance, is normal or near normal.I can take care of myself but might not be able to do heavy physical work.I have not had serious irregular heartbeats like ventricular tachycardia.My infections are treated and under control.I do not have another cancer that needs treatment or is expected to shorten my life within a year.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (venetoclax, azacitidine)
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.
How many participants are the maximum capacity for this research endeavor?
"Affirmative. The clinicaltrials.gov listing for this medical research confirms that recruitment is currently underway and began on June 30th 2022. This study aims to sign up 53 participants from one site, with the most recent update posted on July 6th 2022."
Answered by AI
Can you provide any evidence of the security associated with Azacitidine?
"Power's assessment of Azacitidine's safety is a 2. This score reflects the fact that there exists some clinical data in support of its security, however none which affirms its effectiveness as it is still only in Phase 2 trials."
Answered by AI
Are there any vacant spots for potential contributors to this research?
"This medical study is actively seeking volunteers, with the trial's first post on June 30th 2022 and its most recent update occuring a few days later."
Answered by AI
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