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 States52 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 range1 Year – 21 Years
SexALL
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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…
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