CompletedPhase 2

Alvocidib, Cytarabine, and Mitoxantrone in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

United States78 participantsStarted 2008-11

Plain-language summary

This randomized phase II trial is studying two different schedules of alvocidib to compare how well they work when given together with cytarabine and mitoxantrone in treating patients with newly diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as alvocidib, cytarabine, and mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known which schedule of alvocidib is more effective when given together with cytarabine and mitoxantrone in treating patients with acute myeloid leukemia.

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: * Pathologically confirmed newly diagnosed acute myeloid leukemia (AML) meeting the following criteria: * Subtypes M0, M1, M2, M4-7 * No acute promyelocytic leukemia (M3) * At least 50 years of age OR \>= 18 years of age with \>= 1 of the following poor-risk disease features: * Antecedent hematologic disorder, including myelodysplastic syndromes (MDS)-related AML or prior myeloproliferative disorder (MPD) * Treatment-related AML, AML with trilineage dysplasia * Myeloid sarcoma, myeloid proliferations related to Down Syndrome, or blastic plasmacytoid dendritic cell neoplasm * AML with trilineage dysplasia * AML with adverse cytogenetics (defined as -5/-5q; -7/-7q; abnormal 3q, 9q, 11q, 20q, 21q, or 17p; t\[6;9\]; t\[9;22\]; trisomy 8; trisomy 13, complex karyotypes \[\>= 3 unrelated abnormalities\]), * No hyperleukocytosis with \>= 50,000 blasts/uL (leukapheresis or hydroxyurea allowed for cytoreduction immediately prior to the first dose of alvocidib) * No active CNS leukemia * ECOG performance status 0-2 * Serum creatinine =\< 2.0 mg/dL * ALT/AST =\< 5 times upper limit of normal * Bilirubin =\< 2.0 mg/dL * Not pregnant or nursing * Negative pregnancy test * No active uncontrolled infection * Infection that is under active treatment allowed provided it is controlled with antibiotics * No other life-threatening illness * No mental deficits and/or psychiatric history that would preclude giving informed consent or following study requirements …

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

Complete Response

Timeframe: 1 year

Trial details

NCT IDNCT00795002

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2010-11

Results submitted2013-01-08

View on ClinicalTrials.gov More Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome trials