Bortezomib and Combination Chemotherapy in Treating Younger Patients With Recurrent, Refractory, … (NCT00666588) | Clinical Trial Compass
CompletedPhase 2
Bortezomib and Combination Chemotherapy in Treating Younger Patients With Recurrent, Refractory, or Secondary Acute Myeloid Leukemia
United States, Australia, Canada52 participantsStarted 2008-04
Plain-language summary
This phase II trial is studying the side effects and best dose of bortezomib and to see how well it works when given together with combination chemotherapy in treating younger patients with recurrent, refractory, or secondary acute myeloid leukemia (AML). Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as idarubicin, cytarabine, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with bortezomib may kill more cancer cells
Who can participate
Age range
1 Year – 21 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:
* Diagnosis of acute myeloid leukemia (AML) according to WHO classification
* At least 5% blasts in the bone marrow
* With or without extramedullary disease
* To be eligible for the dose-finding phase (closed as of 10/10) :
* Relapsed patients must meet the following criteria:
* Must have had a prior diagnosis of AML, but may NOT have inv(16) or t(8;21) cytogenetics
* May be in first or any subsequent relapse
* If in first relapse, remission duration must be less than one year
* Refractory patients must meet the following criteria:
* Must have had a prior diagnosis of AML
* May have received one or more attempt at remission induction
* Patients with treatment-related AML may be previously treated or untreated for secondary AML
* To be eligible for the efficacy phase:
* Relapsed patients must meet the following criteria:
* Must have had a prior diagnosis of AML, with no restriction on prior cytogenetics
* Must be in first relapse
* Must not have received prior reinduction therapy
* Refractory patients must meet the following criteria:
* Must have had a prior diagnosis of AML
* Must not have received more than one attempt at remission induction (which may consist of up to two therapy courses)
* Patients with treatment-related AML must be previously untreated for secondary AML
* No juvenile myelomonocytic leukemia or acute promyelocytic leukemia (APL; FAB M3)
* Patients with the following CNS sta…
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
1
Dose Limiting Toxicity
Timeframe: During Course 1
2
Overall Response (Complete Remission [CR] and CR With Partial Recovery [CRp]) During Course 1