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

Clinical Trial: NCT02749708

Study of IRX5183 in Relapsed and Refractory Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome
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.