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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

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

~1720

Filgrastim

2000

Completed Phase 3

~3690