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Decitabine + Filgrastim for Acute Myeloid Leukemia (MORE Trial)
Phase 2
Recruiting
Led By Franziska Wachter, MD
Research Sponsored by Franziska Wachter
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial seeks to evaluate the safety and effectiveness of administering Decitabine and Filgrastim after HCT to treat children and young adults with myelodysplastic syndrome and related disorders.
Who is the study for?
This trial is for children and young adults aged 1 to 39 with myeloid malignancies like AML or MDS, who are undergoing stem cell transplants. They must be in remission, HIV-positive patients on effective therapy can join, as well as those with treated hepatitis B or C. Pregnant women cannot participate, and participants need a good performance status without severe heart disease.
What is being tested?
The study tests the feasibility of using decitabine (a DNA methylation inhibitor) combined with filgrastim (a bone marrow stimulant) after stem cell transplant to prevent cancer relapse in young patients with certain blood disorders.
What are the potential side effects?
Decitabine may cause side effects such as low blood counts leading to increased infection risk, bleeding issues, tiredness, and nausea. Filgrastim can lead to bone pain, headaches, fatigue and sometimes enlarge the spleen or cause allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility Failure Rate (FFR)
Secondary study objectives
24-Month Probability Event-Free Survival (EFS)
24-Month Probability Overall Survival (OS)
Treatment Tolerability Rate (TTR)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort B: inherited bone marrow failure (iBMF) with Increased Risk for treatment related toxicitiesExperimental Treatment2 Interventions
Participants with MDS, AML, AML/MDS, tAML/MDS with iBMF with increased risk for treatment related toxicities will be enrolled and will undergo study procedures as outlined:
* Cycles 1: Study treatment must occur 40 - 120 days post allogenic HCT.
* Day 2 - 6 of 28-day cycle: Predetermined dose of Decitabine.
* Day 1 - 6 of 28-day cycle: Predetermined dose of Filgrastim.
* Cycles 2 - 6:
* Day 2 - 6 of 28-day cycle: Predetermined dose of Decitabine.
* Day 1 - 6 of 28-day cycle: Predetermined dose of Filgrastim.
* Follow up visit every 6 months for 24 months post allogenic HCT.
Group II: Cohort A: Standard RiskExperimental Treatment2 Interventions
Participants with MDS, AML, AML/MDS, treatment related myeloid neoplasm (tAML/MDS) with either idiopathic disease or inherited bone marrow failure syndrome (iBMF) with standard risk for treatment related toxicities will be enrolled and will undergo study procedures as outlined:
* Cycles 1: Study treatment start must occur 40 - 120 days post allogenic HCT.
* Day 2 - 6 of 28-day cycle: Predetermined dose of Decitabine.
* Day 1 - 6 of 28-day cycle: Predetermined dose of Filgrastim.
* Cycles 2 - 6:
* Day 2 - 6 of 28-day cycle: Predetermined dose of Decitabine.
* Day 1 - 6 of 28-day cycle: Predetermined dose of Filgrastim.
* Follow up visit every 6 months for 24 months post allogenic HCT.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Decitabine
2004
Completed Phase 3
~1680
Filgrastim
2000
Completed Phase 3
~3690
Find a Location
Who is running the clinical trial?
Franziska WachterLead Sponsor
Harvard Clinical and Translational Science Center (Harvard Catalyst)UNKNOWN
Franziska Wachter, MDPrincipal InvestigatorDana-Farber Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to use birth control during the study.I have severe side effects from previous cancer treatments.I am in remission and show no minimal residual disease after a stem cell transplant.My organs are healthy enough for a stem cell transplant.I have another active cancer besides the one being studied.I am receiving a stem cell transplant from a donor.I am between 1 and 39 years old.I can take care of myself but might not be able to do heavy physical work.I do not have any unmanaged ongoing illnesses.I meet the criteria for my genetic condition to join the trial.I have chronic hepatitis B but it's under control with medication.I had hepatitis C but am now cured or have no detectable virus with treatment.My cancer is currently in remission.My leukemia has FLT3/ITD mutations.I have been diagnosed with AML, MDS, or a related blood disorder.My heart condition does not severely limit my daily activities.I am HIV-positive, on treatment, and my viral load has been undetectable for 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A: Standard Risk
- Group 2: Cohort B: inherited bone marrow failure (iBMF) with Increased Risk for treatment related toxicities
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.
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