CompletedPhase 2

Imatinib Mesylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia Who Have Received Chemotherapy

United States32 participantsStarted 2008-10

Plain-language summary

RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating patients with newly diagnosed acute myeloid leukemia who have received chemotherapy.

Who can participate

Age range

18 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 * Diagnostic bone marrow aspirate/ biopsy or peripheral blood confirming AML. * At the time of diagnosis, patients must have c-kit (also known as CD117) positive AML (20% or more of the blasts express c-kit\[CD117\]). * A flow scattergram (from the diagnostic AML specimen) must be available to calculate a c-kit MFI. * Patients must have received standard induction chemotherapy with ADE (cytarabine, daunorubicin, and etoposide) or with 7+3 (7 days of cytarabine continuous infusion and 3 days of an anthracycline (idarubicin, daunorubicin, or mitoxantrone). Patients with persistent leukemia on a Day 10-28 marrow may have received a second course of chemotherapy. * After the completion of induction therapy, patients must have attained a complete remission based on blood count recovery (neutrophil count ≥ 1,000/µL, platelet count ≥ 100,000/µL), and bone marrow aspirate and biopsy (\< 5% myeloblasts). * For patients \< 60 years of age, patients must have received at least 2 courses of post-remission therapy with at least intermediate dose (400 mg/m2/day). \*Patients with t(8;21) or inversion 16 at the time of diagnosis must have received at least 2 courses of high dose cytarabine. For patients \> or = 60 years of age, patients must have received 1 course of post-remission therapy (the type of chemotherapy will not be specified). * Patients must be registered on this study (maintenance Imatinib mesylate) within 60 days of the last dose of post-remission therapy. …

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

Median Progression-free Survival (PFS) for Patients Less Than 60 Years of Age

Timeframe: up to 5 years from the End of Treatment

Progression-free Survival for Patients 60 Years of Age and Older

Timeframe: up to 5 years from the End of Treatment

Percent of Participants Less Than 60 Years of Age With PFS at 8 and 13 Months Post-treatment

Timeframe: at 8 and 13 months after treatment.

Percent of Participants 60 Years of Age or Older With PFS at 8 and 13 Months Post-treatment

Timeframe: at 8 and 13 months after treatment.

Trial details

NCT IDNCT00509093

SponsorCase Comprehensive Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-05-09

Results submitted2020-02-20

View on ClinicalTrials.gov More Leukemia trials

Who can participate

Age range

18 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.

What they're measuring

Median Progression-free Survival (PFS) for Patients Less Than 60 Years of Age

Timeframe: up to 5 years from the End of Treatment

Progression-free Survival for Patients 60 Years of Age and Older

Timeframe: up to 5 years from the End of Treatment

Percent of Participants Less Than 60 Years of Age With PFS at 8 and 13 Months Post-treatment

Timeframe: at 8 and 13 months after treatment.

Percent of Participants 60 Years of Age or Older With PFS at 8 and 13 Months Post-treatment

Timeframe: at 8 and 13 months after treatment.