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About
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).
Full description
This research is being done to learn about the safety and effectiveness of an investigational drug, IRX5183, in treating acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). IRX5183 is a derivative of Vitamin A. IRX5183 is a drug that is designed to cause cancer cells to mature and then die. It is thought that it will stop the uncontrolled growth of leukemia cells.
These are 2 parts to this study. The purpose of the first part is to test the safety of IRX5183 at different dose levels. The investigators want to find out what effects, good and/or bad, it has on AML or MDS. Once the investigators figure out the best and safest dose of IRX5183, the investigators will enter the second part of the study using this dose. The purpose of the second part is to see if IRX5183 is effective as a treatment for AML or MDS. To date, IRX5183 has been used in about 25 people.
The first part of the study is called a "Phase I" study. Phase I studies use drugs starting at low doses and slowly increase the amounts of the study drugs that are given to people until the side effects of the drugs are too high to give more. This means that not all people in the study will get the same dose of IRX5183. Doses at the beginning of the study will be lower than doses at the end of the study. Because of the design of the study, some people may get doses that are too low to have an effect, and other people will probably get doses that cause side effects.
People with AML, MDS, or CMML that has 1) not responded to standard therapy or 2) has returned after a previous response may join.
Enrollment
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Inclusion criteria
Patients must be able to understand and voluntarily sign an informed consent form.
Age ≥ 18 years at the time of signing the informed consent form.
Able to adhere to the study visit schedule and other protocol requirements.
Pathologically confirmed disease with A or B as follows:
A) AML patients who either have:
B) MDS, CMML, or MDS/myeloproliferative neoplasm (MPN) with high risk features as defined below who have relapsed after initial response or are refractory (failure to achieve a complete remission (CR), partial remission (PR), or hematologic improvement (HI)) after receiving at least 4 cycles of hypomethylating agents 5-azacitidine or decitabine ± other therapies ± bone marrow transplant OR with de novo MDS but have refused to receive hypomethylating therapy:
Eastern Cooperative Oncology Group performance status of ≤ 2 at study entry or Karnofsky > 60%.
Laboratory test results within these ranges:
Creatinine level of 3 mg/dL or lower, total bilirubin ≤ 3 mg/dL unless due to Gilbert's syndrome, hemolysis, or ineffective hematopoiesis, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x upper limit of normal, white blood count (WBC) ≤ 10,000/µL
Patients must not have received any other treatment for their disease, including hematopoietic growth factors, aside from hydroxyurea for count control, within three weeks of beginning the trial, and should have recovered from all toxicities of prior therapy (to grade 0 or 1).
Patients requiring hydroxyurea to bring WBC below 10,000/µL prior to study enrollment will require a 48-hour washout prior to starting the study drug.
Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to start of IRX5183.
Patients must have no clinical evidence of central nervous system (CNS) or pulmonary leukostasis, disseminated intravascular coagulation, or CNS leukemia.
Exclusion criteria
Primary purpose
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13 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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