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Association details:
Evidence:
Evidence Level:
Sensitive: B - Late Trials
New
Title:

SNDX-5613 Granted FDA Fast Track Designation for the Treatment of Relapsed/Refractory Acute Leukemias

Published date:
06/28/2021
Excerpt:
Syndax Pharmaceuticals, Inc...today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to SNDX-5613 for the treatment of adult and pediatric patients with relapsed or refractory acute leukemias harboring a mixed lineage leukemia rearranged (MLLr) or nucleophosmin (NPM1) mutation.
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

A study to investigation the short- and long-term safety and tolerability of the drug SNDX-5613 in Patients with Relapsed/Refractory Leukemias. Various doses of SNDX-5613 will be investigated.

Excerpt:
...Patients in Arms A and B must have active acute leukemia harboring mixed lineage leukemia (MLL) rearrangement or NPM1c mutation as defined by the National Comprehensive Cancer Network (NCCN) in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ®) for Acute Lymphoblastic Leukemia (Ver 1.2020) and Acute Myeloid Leukemia (Ver 3.2020). ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Go to data
Title:

A Study of SNDX-5613 in R/R Leukemias Including Those With an MLLr/KMT2A Gene Rearrangement or NPM1 Mutation

Excerpt:
...Patients must have active acute leukemia (bone marrow blasts ≥ 5% or reappearance of blasts in peripheral blood) as defined by the National Comprehensive Cancer Network (NCCN) in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Lymphoblastic Leukemia (Version 1.2020) and Acute Myeloid Leukemia (Version 3.2020), or acute leukemia harboring an MLL rearrangement, NUP98 rearrangement, or NPM1 mutation that have detectable disease in the bone marrow....
Trial ID:
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Preliminary phase I results of the AUGMENT-101 trial demonstrate clinical activity of SNDX-5613 in adults with relapsed/refractory acute leukemias

Published date:
05/01/2020
Excerpt:
One patient...had a complete response with incomplete blood count recovery (CRi) after 28 days of therapy that then improved to a complete response (CR)...Preliminary phase I data indicated that SNDX-5613 can induce response in patients with MLL-r rapidly.SNDX-5613 could induce durable response in a select population of patients with MLL-r acute leukemias...
Trial ID: