Bortezomib, Daunorubicin, and Cytarabine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia

Completed · Phase 1/Phase 2

Conditions studied: Acute Myeloid Leukemia, Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), 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 Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Myelomonocytic Leukemia (M4), Adult Erythroleukemia (M6a), Adult Pure Erythroid Leukemia (M6b), Untreated Adult Acute Myeloid Leukemia

In brief

This phase II trial studies the side effects and best dose of bortezomib when given together with daunorubicin and cytarabine and to see how well it works in treating older patients with previously untreated acute myeloid leukemia. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as daunorubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with combination chemotherapy may kill more cancer cells.

Key facts

Study ID

NCT00742625

Run by

National Cancer Institute (NCI)

People needed

95

Starts

2008-09-01

Expected to finish

2012-12-01

Last updated by the study team

2014-09-12

Who can join

Age: 60 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Unequivocally histologically confirmed acute myeloid leukemia (AML)
• At least 20% blasts in the bone marrow based on WHO criteria
• No acute promyelocytic leukemia (M3)
• Antecedent hematologic disorder or myelodysplastic syndromes allowed provided the patient did not receive cytotoxic chemotherapy, including azacitidine and decitabine, for their pre-leukemic disorder
• Concurrent enrollment on CALGB-8461 required
• Not pregnant or nursing
• Fertile patients must use effective contraception
• No ataxia, cranial neuropathy, or peripheral neuropathy >= grade 2
• LVEF >= 40% by ECHO or MUGA scan
• No signs or symptoms of congestive heart failure
• DLCO >= 50% (corrected for hemoglobin)
• No prior therapy for leukemia or pre-leukemic disorders, except for the following:
• emergency leukapheresis;
• emergency treatment for hyperleukocytosis with hydroxyurea;
• cranial radiotherapy for CNS leukostasis (one dose only);
• growth factor/cytokine support
• No other concurrent chemotherapy, except for the following:
• I) steroids administered for adrenal failure, hypersensitivity reactions, or septic shock;
• II) hormones administered for non-disease-related conditions (e.g., insulin for diabetes or estrogens or progestins for gynecologic indications)
• No concurrent palliative radiotherapy

Where it is running

• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Lombardi Comprehensive Cancer Center at Georgetown University — Washington D.C., District of Columbia, United States
• Florida Hospital — Orlando, Florida, United States
• University of Chicago — Chicago, Illinois, United States
• Eastern Maine Medical Center — Bangor, Maine, United States
• University of Maryland/Greenebaum Cancer Center — Baltimore, Maryland, United States
• Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• University of Missouri - Ellis Fischel — Columbia, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• North Shore University Hospital — Manhasset, New York, United States
• North Shore-LIJ Health System CCOP — Manhasset, New York, United States
• Long Island Jewish Medical Center — New Hyde Park, New York, United States
• North Shore-LIJ Health System/Center for Advanced Medicine — New Hyde Park, New York, United States
• Mount Sinai Medical Center — New York, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Kinston Medical Specialists PA — Kinston, North Carolina, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center — Columbus, Ohio, United States
• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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