NCT01420926

Decitabine With or Without Bortezomib in Treating Older Patients With Acute Myeloid Leukemia

A Randomized Phase II Trial of Decitabine-Based Induction Strategies for Patients >/= 60 Years Old With Acute Myeloid Leukemia (AML)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase II trial studies how well giving decitabine with or without bortezomib works in treating older patients with acute myeloid leukemia. Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells,by stopping them from dividing, or by stopping them from spreading. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether decitabine works better when given with or without bortezomib in treating acute myeloid leukemia.

Detailed description

PRIMARY OBJECTIVE: I. To determine if treatment of older acute myeloid leukemia (AML) patients with decitabine and bortezomib significantly improves the overall survival times of older AML patients compared with decitabine alone. SECONDARY OBJECTIVES: I. To determine the rate of complete remission (CR and CR + incomplete blood count recovery \[CRi\]) for each of the 2 treatment regimens in the proposal. II. To determine the overall survival, progression-free survival, disease-free survival and for each of the treatment regimens on this study. III. To determine whether ongoing treatment with these regimens prolongs overall survival even in the absence of complete remission. IV. To describe the frequency and severity of adverse events, as well as the tolerability of each of these regimens in patients treated on this study. V. To describe the interaction of pretreatment disease and patient characteristics including morphology, cytogenetics, molecular genetics, white blood cell (WBC) count, blood and bone marrow blast count, age, performance status and comprehensive geriatric assessment on clinical outcomes. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: REMISSION INDUCTION THERAPY: Patients receive decitabine intravenously (IV) over 1 hour once daily (QD) on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CR with CRi proceed to continuation therapy. Patients achieving CR or CR with CRi proceed to maintenance therapy. CONTINUATION THERAPY: Patients receive decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM B: REMISSION INDUCTION THERAPY: Patients receive decitabine IV over 1 hour QD on days 2-11 and bortezomib subcutaneously (SC) on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CR with CRi proceed to maintenance therapy. CONTINUATION THERAPY: Patients receive bortezomib SC on day 1 and decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive bortezomib SC on day 1 and decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 2 months for 2 years, every 3 months for 2 years, and then once a year for a maximum of 10 years from study entry.

Conditions

• Acute Myeloid Leukemia
• Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
• Therapy-Related Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Bortezomib	Given SC
DRUG	Decitabine	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacological Study	Correlative studies
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2011-11-16
• Primary completion: 2016-06-05
• Completion: 2021-04-01
• First posted: 2011-08-22
• Last updated: 2023-02-28
• Results posted: 2016-10-24

Locations

53 sites across 1 country: United States