Bortezomib and Combination Chemotherapy in Treating Younger Patients With Recurrent, Refractory, or Secondary Acute Myeloid Leukemia

Completed · Phase 2

Conditions studied: Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloblastic Leukemia With Maturation (M2), Adult Acute Myeloblastic Leukemia Without Maturation (M1), Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myelomonocytic Leukemia (M4), Childhood Acute Basophilic Leukemia, Childhood Acute Eosinophilic Leukemia, Childhood Acute Erythroleukemia (M6), Childhood Acute Megakaryocytic Leukemia (M7), Childhood Acute Minimally Differentiated Myeloid Leukemia (M0), Childhood Acute Monoblastic Leukemia (M5a), Childhood Acute Monocytic Leukemia (M5b), Childhood Acute Myeloblastic Leukemia With Maturation (M2), Childhood Acute Myeloblastic Leukemia Without Maturation (M1), Childhood Acute Myelomonocytic Leukemia (M4), Recurrent Adult Acute Myeloid Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Secondary Acute Myeloid Leukemia

In brief

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

Key facts

Study ID: NCT00666588
Run by: National Cancer Institute (NCI)
People needed: 52
Starts: 2008-04-01
Expected to finish: 2012-12-01
Last updated by the study team: 2018-05-22

Who can join

Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 status are eligible only in the absence of neurologic symptoms suggestive of CNS leukemia, such as cranial nerve palsy:
CNS 1, defined as absence of blasts in cerebral spinal fluid (CSF) on cytospin preparation, regardless of the number of WBCs
CNS 2, defined as presence of < 5/μL WBCs in CSF and cytospin positive for blasts, or > 5/uL WBCs but negative by Steinherz/Bleyer algorithm:

Where it is running

Phoenix Childrens Hospital — Phoenix, Arizona, United States
University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
Southern California Permanente Medical Group — Downey, California, United States
Miller Children's Hospital — Long Beach, California, United States
Children's Hospital and Research Center at Oakland — Oakland, California, United States
Childrens Hospital of Orange County — Orange, California, United States
Packard Children's Hospital Stanford University — Palo Alto, California, United States
University of California San Francisco Medical Center — San Francisco, California, United States
Connecticut Children's Medical Center — Hartford, Connecticut, United States
Alfred I duPont Hospital for Children — Wilmington, Delaware, United States
Children's National Medical Center — Washington D.C., District of Columbia, United States
Broward General Medical Center — Fort Lauderdale, Florida, United States
Lee Memorial Health System — Fort Myers, Florida, United States
Nemours Children's Clinic - Jacksonville — Jacksonville, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida, United States
Nemours Childrens Clinic - Orlando — Orlando, Florida, United States
Nemours Children's Clinic - Pensacola — Pensacola, Florida, United States
All Children's Hospital — St. Petersburg, Florida, United States
Saint Joseph Children's Hospital of Tampa — Tampa, Florida, United States
Children's Healthcare of Atlanta - Egleston — Atlanta, Georgia, United States
Memorial Health University Medical Center — Savannah, Georgia, United States
University of Hawaii — Honolulu, Hawaii, United States
Childrens Memorial Hospital — Chicago, Illinois, United States
Southern Illinois University — Springfield, Illinois, United States
University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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