Bortezomib and Sorafenib Tosylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
NCT01371981 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1645
Last updated 2025-11-26
Summary
This randomized phase III trial studies how well bortezomib and sorafenib tosylate work in treating patients with newly diagnosed acute myeloid leukemia. Bortezomib and sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib and sorafenib tosylate together with combination chemotherapy may be an effective treatment for acute myeloid leukemia.
Conditions
- Acute Myeloid Leukemia
- Leukemia Cutis
- Myeloid Neoplasm
- Myeloid Sarcoma
Interventions
- DRUG
-
Asparaginase
Given IM
- DRUG
-
Given IV
- DRUG
-
Given IT or IV
- DRUG
-
Daunorubicin Hydrochloride
Given IV
- DRUG
-
Etoposide
Given IV
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
- DRUG
-
Mitoxantrone Hydrochloride
Given IV
- OTHER
-
Pharmacological Study
Correlative studies
- OTHER
-
Quality-of-Life Assessment
Ancillary studies
- OTHER
-
Questionnaire Administration
Ancillary studies
- DRUG
-
Sorafenib Tosylate
Given PO
Sponsors & Collaborators
-
National Cancer Institute (NCI)
lead NIH
Principal Investigators
-
Richard Aplenc · Children's Oncology Group
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Max Age
- 29 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-06-20
- Primary Completion
- 2019-03-31
- Completion
- 2027-09-30
- FDA Drug
- Yes
Countries
- United States
- Australia
- Canada
- New Zealand
- Puerto Rico
Study Locations
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