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DNA Methyltransferase Inhibitor and Cytidine Deaminase Inhibitor
Itacitinib + ASTX727 for MDS/MPN (ABNL-MARRO Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Michael Savona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
Creatinine < 1.5x ULN or estimated creatinine clearance (eCCR) >/=40 ml/min/1.73m2 eCCR may be calculated using the standard institutional formula.
Must not have
Any known contraindications to the use of ASTX727.
Patients who require continuation of a prohibited concomitant medication for which no alternative therapy or allowable substitute is available.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing new treatment combinations for people with myelodysplastic/myeloproliferative neoplasms (MDS/MPN).
Who is the study for?
This trial is for adults with MDS/MPN overlap syndromes who haven't had certain treatments, can undergo bone marrow procedures, and have a life expectancy of at least 3 months. They must be able to perform daily activities with minimal assistance (ECOG status 0-2) and have proper liver and kidney function. Pregnant or breastfeeding women, those unwilling to use contraception, or individuals with recent other cancer treatments are excluded.
What is being tested?
The ABNL-MARRO study tests combinations of itacitinib (a drug targeting myeloid cells) and ASTX727 (an oral tablet combining decitabine and cedazuridine) in patients with MDS/MPN overlap syndromes. It's an open-label phase 1/2 trial where the effectiveness of these drugs together will be evaluated.
What are the potential side effects?
Potential side effects may include reactions related to bone marrow procedures, changes in blood counts leading to increased infection risk or bleeding tendencies, fatigue from treatment, possible liver or kidney function alterations due to medication toxicity, as well as any individual allergies or intolerances.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
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My kidney function is within the required range.
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My condition is officially diagnosed as MDS/MPN, not JMML, following WHO guidelines.
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I have recovered from previous cancer treatments, except for hair loss.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have no known allergies or adverse reactions to ASTX727.
Select...
I need to keep taking a medication that this trial doesn't allow, and there's no alternative.
Select...
I haven't taken cancer drugs or treatments within the last 21 days or 5 half-lives, whichever is shorter.
Select...
I do not have any current, serious bleeding issues.
Select...
I am not pregnant or breastfeeding.
Select...
My leukemia has progressed to a more severe form with a high number of abnormal cells.
Select...
I had major radiation therapy within the last month or smaller radiation for symptom relief in the last 2 weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Dose-limiting toxicity (phase 1)
Overall response (phase 2)
Secondary study objectives
Applicability of the proposed MDS/MPN IWG response criteria across multiple Arms of this study.
Effect of each treatment combination on patient survival
Side effects data
From 2023 Phase 3 trial • 227 Patients • NCT0330626459%
Thrombocytopenia
51%
Anaemia
34%
Neutropenia
26%
Febrile neutropenia
25%
Asthenia
23%
Pyrexia
21%
Nausea
21%
Diarrhoea
20%
Oedema Peripheral
20%
Pneumonia
19%
Hypokalaemia
19%
Constipation
15%
Decreased Appetite
13%
Vomiting
11%
Cough
11%
Fatigue
11%
Back Pain
11%
Haematoma
11%
Insomnia
11%
Leukopenia
10%
Hypertension
10%
Arthralgia
10%
Urinary Tract Infection
10%
Fall
10%
Dizziness
9%
Epistaxis
9%
Febrile Neutropenia
9%
C-Reactive Protein Increased
8%
Blood Creatinine Increased
8%
Pleural Effusion
8%
Alanine Aminotransferase Increased
8%
Cellulitis
8%
Headache
8%
Haemorrhoids
6%
Corona Virus Infection
6%
Aspartate Aminotransferase Increased
6%
Infection
6%
Acute Kidney Injury
5%
Atrial Fibrillation
5%
Tongue Ulceration
5%
Pain
5%
Hypomagnesaemia
5%
Oral Herpes
5%
Weight Decreased
5%
Dyspnoea
5%
Dry Mouth
5%
Confusional State
4%
Neutropenic Sepsis
4%
Bronchitis
4%
Urinary tract infection
4%
Sepsis
4%
Pleural effusion
3%
Escherichia Bacteraemia
3%
Pneumonia Fungal
3%
Urosepsis
3%
Multiple Organ Dysfunction Syndrome
3%
Gastrointestinal haemorrhage
3%
Bacteraemia
3%
Cerebral haemorrhage
3%
Cardiac Failure
1%
Intestinal Ischaemia
1%
Ankle Fracture
1%
Escherichia Urinary Tract Infection
1%
Klebsiella Bacteraemia
1%
Exposure To Communicable Disease
1%
Polyserositis
1%
Jaundice Cholestatic
1%
Bronchopulmonary aspergillosis
1%
Cellulitis Staphylococcal
1%
Sinusitis Aspergillus
1%
Pancreatitis Chronic
1%
Clostridium Colitis
1%
Abdominal Abscess
1%
Septic shock
1%
Pneumonia Necrotising
1%
Cerebrovascular Accident
1%
Acute kidney injury
1%
Ischaemic Stroke
1%
Gastritis
1%
Gastrointestinal Perforation
1%
Pseudomonal bacteraemia
1%
Hyperglycaemia
1%
Proctalgia
1%
Tuberculosis
1%
Multiple Fractures
1%
Renal Failure
1%
Liver Abscess
1%
Cholecystitis Infective
1%
Loss Of Personal Independence In Daily Activities
1%
Pneumonia Viral
1%
Anal Abscess
1%
Subdural Haematoma
1%
Haematotoxicity
1%
Lymphadenitis
1%
Cardiac Failure Congestive
1%
Tachycardia
1%
Haemorrhoidal Haemorrhage
1%
Mucosal Inflammation
1%
Sudden Death
1%
Anorectal Infection
1%
Enterococcal Bacteraemia
1%
Arthritis
1%
Chronic Lymphocytic Leukaemia
1%
Respiratory Distress
1%
Extravasation Blood
1%
Phlebitis
1%
General Physical Health Deterioration
1%
Diverticulitis
1%
Post Procedural Infection
1%
Limb injury
1%
Epilepsy
100%
80%
60%
40%
20%
0%
Study treatment Arm
AML: ASTX727
MDS or CMML: IV Decitabine
MDS or CMML: Not Treated
AML: Not Treated
MDS or CMML: ASTX727
AML: IV Decitabine
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: ASTX727 + itacitinibExperimental Treatment2 Interventions
ASTX727 and itacitinib will be taken by mouth
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ASTX727
2018
Completed Phase 3
~270
Itacitinib
2020
Completed Phase 3
~980
Find a Location
Who is running the clinical trial?
Michael SavonaLead Sponsor
Incyte CorporationIndustry Sponsor
393 Previous Clinical Trials
63,739 Total Patients Enrolled
TheradexIndustry Sponsor
33 Previous Clinical Trials
1,472 Total Patients Enrolled
Astex Pharmaceuticals, Inc.Industry Sponsor
95 Previous Clinical Trials
7,420 Total Patients Enrolled
Michael Savona, MDStudy ChairVanderbilt-Ingram Cancer Center
4 Previous Clinical Trials
173 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver and kidney tests are within normal ranges.I haven't had any previous treatments for my condition, except for medications like erythropoietin or hydroxyurea.I do not have an active, uncontrolled infection.I can take care of myself and am up and about more than half of my waking hours.I do not have serious heart problems or uncontrolled heart disease.I am over 18, have signed the consent form, and can meet the study requirements.I've had a break since my last DNMTi treatment and it didn't work or caused side effects.I have no known allergies or adverse reactions to ASTX727.My kidney function is within the required range.My condition is officially diagnosed as MDS/MPN, not JMML, following WHO guidelines.I need to keep taking a medication that this trial doesn't allow, and there's no alternative.I haven't taken cancer drugs or treatments within the last 21 days or 5 half-lives, whichever is shorter.I do not have any current, serious bleeding issues.I am not pregnant or breastfeeding.I have not been treated with itacitinib but may have had ASTX727.I haven't had major surgery with general anesthesia in the last 4 weeks.My leukemia has progressed to a more severe form with a high number of abnormal cells.I am willing to have bone marrow tests during and throughout the trial.I had major radiation therapy within the last month or smaller radiation for symptom relief in the last 2 weeks.I have no active cancer except for certain localized cancers or have been cancer-free for 2 years.I have recovered from previous cancer treatments, except for hair loss.You are allergic to decitabine.You have received an organ transplant, including a stem cell transplant from another person.
Research Study Groups:
This trial has the following groups:- Group 1: ASTX727 + itacitinib
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.