Clinical Trial: Leukemia and Lymphoma

AAML1031 Acute myeloid leukemia (AML); chemotherapy; high allelic ratio FLT3/itd (PRO00000499)

Full Name

Acute Myeloid leukemia (AAML 1031): A Phase III Randomized Trial for Patients with de novo AML using Bortezomib and Soraferib for patients with High Allelic Ratio FLT3/ITD (1_PRO00000499 - CIRB)


Participants with unknown FLT3 status will be randomized to receive treatment with the standard chemotherapy (Arm A) or treatment with the standard chemotherapy plus bortezomib (Arm B). (Each of these arms has 2 separate treatment plans depending on whether the participant is considered high risk or low risk.) Participants with known HR FLT3/ITD+ status at time of study will be offered enrollment onto the sorafenib treatment arm (Arm C). If treatment with sorafenib is declined, they may be offered enrollment into Arm A or B and will be treated on the high risk, intensified arm. Patients subsequently determined to HR FLT3/ITD+ will be offered enrollment to the sorafenib treatment arm (Arm C); if they decline, they may continue on the arm initially assigned.              


Inclusion Criteria

Includes but may not be limited to:

Age 30 years or younger

Newly diagnosed with de novo acute myelogenous leukemia

No prior chemo, radiation, or antileukemic therapy

Cannot be pregnant or breastfeeding

Must agree to a pregnancy test

Must use effective contraception for duration of study