Study of IRX5183 in Relapsed and Refractory Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome | Aplastic Anemia & MDS International Foundation Return to top.
Study of IRX5183 in Relapsed and Refractory Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome

Clinical Trial: NCT02749708

For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

The purpose of this study is to evaluate the use of IRX5183 in 1) patients with relapsed and/or refractory AML and 2) patients with high-risk MDS or chronic myelomonocytic leukemia (CMML).

Status: 
Not yet recruiting
Study Date: 
Fri, 04/01/2016 ( ) to Thu, 12/01/2022 ( )
Bone Marrow Disease(s): 
  • myelodysplastic syndromes (MDS)
Intervention: 
Drug: IRX5183 IRX5183 will be administered orally daily on days 1-28 of each cycle for 2 cycles of induction. In the phase I part of the study, there will be 3 dose levels (dose level 1 [DL1] with 50 mg, DL2 with 75 mg, and DL3 with 100 mg), with 1 additional dose level to be only used if excessive toxicity noted at the DL1. There will be no intra-patient dose escalation. In the phase II part of the study, the investigators will use the optimal dose identified in phase I and will aim to recruit a total of 27 patients per a Simon's 2 stage design. After induction, all patients who do not experience significant toxicity or disease progression will continue on a consolidation/maintenance phase of the study in which 4 additional 28-day cycles of IRX5183 will be administered. This phase will use the same dose used in the induction phase for each individual patient.
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