Ixazomib in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
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 Erythroleukemia (M6a)
Adult Pure Erythroid Leukemia (M6b)
Recurrent Adult Acute Myeloid Leukemia
Other: laboratory biomarker analysis
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Single-Agent MLN9708 for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia (AML) With Mutated Nucleophosmin-1 (NPM1+)|
- Response rate, defined as the best of CR, CRi or PR assessed according to the LeukemiaNet guidelines [ Time Frame: Up to day 63 ]The response rate will be accompanied by a two-sided 90% exact confidence interval.
- Duration of response [ Time Frame: At 2 years ]Kaplan-Meier methods will be used to estimate duration of response.
- Median overall survival [ Time Frame: Time of study entry to the earlier of death from any cause or end of follow up, assessed at 1 year ]Kaplan-Meier methods will be used to estimate duration of response.
- Dose-limiting toxicities (DLT), defined as any grade 4 or select >= 3 non-hematologic toxicity graded according to the CTCAE version 4.0 [ Time Frame: Up to 2 years ]
- Incidence of adverse events, graded according to the CTCAE version 4.0 [ Time Frame: Up to 2 years ]
|Study Start Date:||March 2014|
|Study Completion Date:||November 2015|
|Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
Experimental: Treatment (ixazomib)
Patients receive ixazomib 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.
Other Names:Other: laboratory biomarker analysis
I. To 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 patients with nucleophosmin (NPM)1-mutated acute myeloid leukemia (AML) (following the LeukemiaNet1 guidelines for response criteria).
I. To determine the duration of remission in all responders after treatment with MLN9708 defined as the time of documented remission until relapse.
II. To 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.
III. To 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.
Patients 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02030405
|United States, California|
|Stanford University Cancer Institute|
|Stanford, California, United States, 94305|
|Principal Investigator:||Bruno de Medeiros||Stanford University Hospitals and Clinics|