A Phase III Randomized Trial for Patients with de novo AML using Bortezomib (IND# 58443, NSC# 681239) and Sorafenib (BAY 43-9006, IND# 69896, NSC# 724772) for Patients with High Allelic Ratio FLT3 ITD

  • STATUS
    Recruiting
Updated on 25 March 2021

Summary

A Phase III Randomized Trial for Patients with de novo AML using Bortezomib (IND# 58443, NSC# 681239) and Sorafenib (BAY 43-9006, IND# 69896, NSC# 724772) for Patients with High Allelic Ratio FLT3 ITD

Description

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.

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For more information, please contact:
844.229.3710
646.776.7532 (local)
Bayer@emergingmed.com

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Details
Clinical Study IdentifierTX152923
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients must be newly diagnosed with de novo acute myelogenous leukemia
Patients with previously untreated primary AML who meet the customary criteria for AML with ≥ 20% bone marrow blasts as set out in the 2008 World Health Organization (WHO) Myeloid Neoplasm Classification are eligible
Attempts to obtain bone marrow either by aspirate or biopsy must be made unless clinically prohibitive; in cases where it is clinically prohibitive, peripheral blood with an excess of 20% blasts and in which adequate flow cytometric and cytogenetics/fluorescent in situ hybridization (FISH) testing is feasible can be substituted for the marrow exam at diagnosis
Patients with > 20% bone marrow blasts are eligible if they have
A karyotypic abnormality characteristic of de novo AML (t(8;21)(q22;q22), inv(16)(p13q22) or t(16;16)(p13;q22) or 11q23 abnormalities
The unequivocal presence of megakaryoblasts, or
Biopsy proven isolated myeloid sarcoma (myeloblastoma; chloroma, including leukemia cutis)
Patients with any performance status are eligible for enrollment
Prior therapy with hydroxyurea, all-trans retinoic acid (ATRA), corticosteroids (any route), and IT cytarabine given at diagnosis is allowed; hydroxyurea and ATRA must be discontinued prior to initiation of protocol therapy; patients who have previously received any other chemotherapy, radiation therapy or any other antileukemic therapy are not eligible for this protocol

Exclusion Criteria

Patients with any of the following constitutional conditions are not eligible
Fanconi anemia
Shwachman syndrome
Any other known bone marrow failure syndrome
Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21
Note: enrollment may occur pending results of clinically indicated studies to
exclude these conditions
Patients with any of the following oncologic diagnoses are not eligible
Any concurrent malignancy
Juvenile myelomonocytic leukemia (JMML)
Philadelphia chromosome positive AML
Biphenotypic or bilineal acute leukemia
Acute promyelocytic leukemia
Acute myeloid leukemia arising from myelodysplasia
Therapy-related myeloid neoplasms Note: enrollment may occur pending results of clinically indicated studies to exclude these conditions
Pregnancy and breast feeding
Female patients who are pregnant are ineligible
Lactating females are not eligible unless they have agreed not to breastfeed their infants
Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation
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