WithdrawnPhase 3

Low-Dose Cytarabine in Treating Infants With Down Syndrome and Transient Myeloproliferative Disorder

Stopped: Per Group Chair: This study will not move forward.

0Started 2006-03

Plain-language summary

RATIONALE: Drugs used in chemotherapy, such as cytarabine, work in different ways to stop the growth of abnormal cells, either by killing the cells or by stopping them from dividing. Giving low-doses of cytarabine may be an effective treatment for Down syndrome and transient myeloproliferative disorder. Sometimes the disease may not need treatment until it progresses. In this case, observation may be sufficient. PURPOSE: This phase III trial is studying low-dose cytarabine to see how well it works in treating infants with Down syndrome and transient myeloproliferative disorder.

Who can participate

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.

DISEASE CHARACTERISTICS: * Diagnosis of transient myeloproliferative disorder (TMD) * Diagnosis of Down syndrome or Down syndrome mosaicism (confirmed by karyotype analysis within the past 3 weeks) AND 1 of the following: * Nonerythroid and nonlymphoid blasts (any amount) in the peripheral blood with verification of a second sample * Trisomy 21-positive leukemic blasts documented by biopsy of any organ (including \> 5% nonerythroid/nonlymphoid blasts documented by bone marrow aspirate or biopsy) * Immunophenotype characterization required * High-, intermediate-, or low-risk TMD, as defined by the following: * High-risk TMD, meeting 1 of the following criteria: * Life-threatening cardio-respiratory compromise due to complications of TMD (e.g., organomegaly or effusions) * Life-threatening cardio-respiratory compromise is defined as cardiovascular grade 4 edema, grade 4 pericardial effusions, or grade 4 pleural effusions * Hyperleukocytosis, defined as a WBC \> 100,000/mm³ * Any degree of hepatomegaly (palpable on physical exam) combined with life-threatening hepatic dysfunction * Life-threatening hepatic dysfunction is defined as grade 4 disseminated intravascular coagulation, grade 4 ascites, grade 4 bilirubin (\> 10.0 times upper limit of normal \[ULN\]), or grade 4 AST or ALT (\> 20.0 times ULN) * Intermediate-risk TMD, meeting all of the following criteria: * Hepatomegaly (palpable on physical exam) combined with non life-threaten…

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

Event-free survival

Trial details

NCT IDNCT00411281

SponsorChildren's Oncology Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2007-11

View on ClinicalTrials.gov More Leukemia trials

Plain-language summary

Who can participate

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.