Study:
A Phase III Randomized Trial for Patients With de Novo AML Using Bortezomib and Sorafenib (IND#114480, NSC# 681239, NSC# 724772) for Patients With High Allelic Ratio FLT3/ITD
Rationale:
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 more than one drug (combination chemotherapy) may kill more cancer
cells. Giving bortezomib and sorafenib tosylate together with combination chemotherapy may
be an effective treatment for acute myeloid leukemia.
Purpose:
This randomized phase II/III trial is studying how well giving bortezomib and sorafenib
tosylate together works in treating patients with newly diagnosed acute myeloid leukemia
with or without mutations. 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 more than one drug (combination chemotherapy) may kill
more cancer cells. Giving bortezomib and sorafenib tosylate together with combination
chemotherapy may be an effective treatment for acute myeloid leukemia
Study Status: Recruiting
Recruiting:
Tanya M. Tekautz 866-223-8100
| Condition |
Intervention |
Phase |
Adult Acute Erythroid Leukemia (M6)
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 Del(5q)
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 Pure Erythroid Leukemia (M6b)
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)
Untreated Adult Acute Myeloid Leukemia
Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies |
Drug: asparaginase
Drug: daunorubicin hydrochloride
Drug: mitoxantrone hydrochloride
Drug: sorafenib tosylate
Drug: cytarabine
Drug: etoposide
Drug: bortezomib |
Phase 3 |
Verified by
National Cancer Institute (NCI)
March, 2013
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov identifier: NCT01371981
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Richard Aplenc., Principal Investigator