Recurrent Adult Acute Myeloid Leukemia Clinical Trial
Official title:
A Phase 2 Study of Single-Agent MLN9708 for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia With Mutated Nucleophosmin-1
This phase 2 trial studies how well ixazomib(MLN9708) works in treating study participants with relapsed or refractory acute myeloid leukemia. Ixazomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVE:
Determine the best response including complete remission (CR), CR with incomplete recovery
(CRi), and partial remission (PR) after 3 cycles of treatment with MLN9708 (ixazomib) in
participants with nucleophosmin (NPM)1-mutated acute myeloid leukemia (AML) (following the
LeukemiaNet1 guidelines for response criteria).
SECONDARY OBJECTIVES:
- Determine the duration of remission in all responders after treatment with MLN9708
defined as the time of documented remission until relapse.
- Determine the 1 year overall survival, which will be measured from time of study entry
to the earlier of death from any cause or end of follow up at 1 year.
- Establish toxicity and tolerability of MLN9708 treatment in AML, including
non-hematologic toxicities grade 3 or above as specified by Common Terminology Criteria
for Adverse Events (CTCAE) version 4.0.
OUTLINE:
Participants receive ixazomib orally (PO) on days 1, 4, 8, and 11. Treatment repeats every 21
days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
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