CompletedPhase 1

Phase I, Dose Escalation Study of Decitabine

United States3 participantsStarted 2014-10

Plain-language summary

Decitabine is a hypomethylating agent that has shown significant anti-leukemic effect in Myelodysplastic Syndrome (MDS) and Acute Myeloblastic Leukemia (AML). This study is based on the hypothesis that Decitabine delivered after allo-hematopoietic stem cell transplant (HSCT) in patients with leukemia will enhance disease control by the allogeneic immune system and lead to a longer disease free survival. The study is designed to provide safety data of low-dosing in the post-transplant setting.

Who can participate

Age range

1 Year – 30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age: greater than 1 and less than 31 years of age; * Diagnosis: history of ALL, AML or MDS, currently in a complete remission (CR) following allo-HSCT (bone marrow leukemic blasts less than 5% by morphology), with high risk features including: * Status post allogeneic HSCT * GVHD prophylaxis: * Karnofsky or Lansky performance scores more than 50%. Karnofsky scores will be used for patients \> 16 years of age and Lansky scores for patients ≤ 16 years of age; * Platelet count ≥ 50,000 (untransfused); * Absolute neutrophil count ≥ 1000; and; * Hemoglobin ≥ 8 g/dL (un-transfused); Exclusion Criteria: * Progressive disease; * Philadelphia chromosome positive ALL (these patients receive tyrosine kinase inhibitor posttransplant); * Known hypersensitivity to any components of decitabine; * Uncontrolled grade 3-4 graft versus host disease; * Uncontrolled infection; * Serum creatinine \> 2 mg/dL or glomerular filtration rate (GFR) less than 60 mL/min/1.73m2 ; * Alanine Aminotransferase (ALT) greater than 3 times normal or serum total bilirubin greater than 2 mg/dL;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Maximum Tolerated Dose as a Measure of Safety and Tolerability

Timeframe: 3 months

Trial details

NCT IDNCT02264873

SponsorUniversity of Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-10

View on ClinicalTrials.gov More Leukemia, Lymphoblastic, Acute trials