CompletedPhase 3

Combination Chemotherapy With or Without Gemtuzumab in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia

United States, Australia, Canada1,070 participantsStarted 2006-08

Plain-language summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as gemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving combination chemotherapy together with gemtuzumab may kill more cancer cells. It is not yet known whether combination chemotherapy is more effective with or without gemtuzumab in treating patients with newly diagnosed acute myeloid leukemia. PURPOSE: This randomized phase III trial is studying combination chemotherapy and gemtuzumab to see how well they work compared with combination chemotherapy alone in treating young patients with newly diagnosed acute myeloid leukemia.

Who can participate

Age range

29 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.

DISEASE CHARACTERISTICS: * Newly diagnosed acute myeloid leukemia (AML) * Meets customary criteria for AML with ≥ 20% bone marrow blasts (by WHO classification) * Patients with \< 20% bone marrow blasts and cytopenia or myelodysplastic syndromes (e.g., chronic myelomonocytic leukemia, refractory anemia (RA), RA with excess blasts, RA with ringed sideroblasts) are eligible provided 1 of the following criteria is met: * Karyotypic abnormality characteristic of de novo AML (t\[8;21\]\[q22;q22\], inv\[16\]\[p13q22\], t\[16;16\]\[p13;q22\], or 11q23 abnormalities) * Unequivocal presence of megakaryoblasts (by WHO classification) * Isolated myeloid sarcoma (i.e., myeloblastoma or chloroma) allowed regardless of bone marrow results * Infants \< 1 month of age with progressive disease\* are eligible NOTE: \*Infants \< 1 month of age with AML may be given supportive care until it is clear that the leukemia is not regressing (i.e., the disappearance of peripheral blasts and the normalization of peripheral blood counts) * Patients with Down syndrome ≥ 4 years of age are eligible * No juvenile myelomonocytic leukemia * No Fanconi's anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndrome * No promyelocytic leukemia (M3) * No secondary or treatment-related AML * Matched family donor criteria (for patients with intermediate-risk or high-risk disease): * HLA-A, -B, -C, and beta chain (-DRB1), identical or 1 antigen or allele m…

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 at 3 Years

Timeframe: Time from study entry to time of induction failure, relapse, or death, assessed at 3 years

Overall Survival at 3 Years

Timeframe: Time from study entry, assessed at 3 years

Trial details

NCT IDNCT00372593

SponsorChildren's Oncology Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2013-08

Results submitted2015-01-06

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