Your session is about to expire
← Back to Search
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
ABNL-MARRO Trial 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.Check my eligibility
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.See study design
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.
ABNL-MARRO Trial 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.
Select...
My kidney function is within the required range.
Select...
My condition is officially diagnosed as MDS/MPN, not JMML, following WHO guidelines.
Select...
I have recovered from previous cancer treatments, except for hair loss.
ABNL-MARRO Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose-limiting toxicity (phase 1)
Overall response (phase 2)
Recommended phase 2 dose (phase 1)
Secondary outcome measures
Applicability of the proposed MDS/MPN IWG response criteria across multiple Arms of this study.
Effect of each treatment combination on patient survival
Morphologic bone marrow response
+1 moreABNL-MARRO 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
~240
Itacitinib
2020
Completed Phase 3
~910
Find a Location
Who is running the clinical trial?
Michael SavonaLead Sponsor
Incyte CorporationIndustry Sponsor
365 Previous Clinical Trials
55,084 Total Patients Enrolled
TheradexIndustry Sponsor
33 Previous Clinical Trials
1,467 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any empty slots in this ongoing clinical trial that new patients could fill?
"The trial, which was originally posted on December 10th 2021, is still recruiting patients according to the information found on clinicaltrials.gov. The page was last edited on June 20th, 2022."
Answered by AI
Is ASTX727 a new medication or has it been studied before?
"ASTX727 is being studied in 130 active clinical trials, 18 of which are in Phase 3. The global locations conducting these medical studies number 1,932, with a significant concentration in Philadelphia, Pennsylvania."
Answered by AI
What medical conditions does ASTX727 target?
"ASTX727 is most often used to treat patients at risk for intermediate-2 ipss, but it can also be taken as a course of treatment for other issues like refractory anemias and high risk ipss."
Answered by AI
How many test subjects are involved in this research project?
"That is correct, the clinical trial indicated on clinicaltrials.gov is actively searching for patients to enroll. The study was first posted on December 10th, 2021 and updated June 20th, 2022. They are looking for 105 participants across 1 location."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger