Study of NEROFE for Advanced MDS and AML
This study is testing a new hormone-peptide called NEROFE in adults with advanced Myelodysplastic Syndromes (MDS) or Acute Myeloid Leukemia (AML). NEROFE is given through an IV (intravenous) infusion. The main goal is to see how well NEROFE works by looking at changes in your disease according to specific medical criteria (IWG Criteria). Researchers also want to find the safest and most effective dose of NEROFE. You may be able to join if you have relapsed/refractory AML or MDS, or if your doctor believes other treatments won't be effective. The study plans to enroll 18 participants.
- Study design
- This is an open-label study, meaning both you and your doctors will know you are receiving NEROFE. It is a Phase 1b study, focusing on safety and finding the right dose, and plans to include 18 participants.
- What's involved
- You would receive NEROFE through an IV infusion on specific days during 28-day cycles, for up to 12 cycles, or longer if you are benefiting. You will have assessments at various points throughout each cycle and at the end of treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for at least 30 days after your last dose of NEROFE. After this period, follow-up will continue only for any ongoing side effects.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study of NEROFE, a Novel Hormone-Peptide in Adult Patients With Advanced MDS and AML
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Assessing change in IWG (International Working Group) Criteria to evaluate response to Nerofe Treatment for MDS patientsAt Screening (Day 1), at cycle 3 (Day 1) at cycle 5 (Day 1), at cycle 7 (Day 1), at cycle 9 (Day 1) at cycle 11 (Day 1) and at End of Treatment Visit. Cycle length is 28 days. Through study completion, an average of 1 year.
Bone Marrow samples to measure percentage of blasts (%). Range 0-30% (the higher percentage the worse outcome)
- Assessing change in IWG (International Working Group) Criteria to evaluate response to Nerofe Treatment for MDS patients. A calculation of several variables.At every cycle on Day 1, Day 3, Day 8, Day 10, Day 12, D15, Day 17, Day 19, Day 22, Day 24, Day 26 and Day 28 (cycle length is 28 days), and at End of Treatment Visit, through study completion, an average of 1 year.
Complete Blood Count (CBC) to measure hemoglobin (g/dL). Range 4-18 (4 worse outcome and 18 best outcome)
- Assessing change in IWG (International Working Group) Criteria to evaluate response to Nerofe Treatment for MDS patients. A calculation of several variables.At every cycle on Day 1, Day 3, Day 8, Day 10, Day 12, D15, Day 17, Day 19, Day 22, Day 24, Day 26 and Day 28 (cycle length is 28 days), and at End of Treatment Visit, through study completion, an average of 1 year.
Complete Blood Count (CBC) to measure absolute neutrophil count (x10\^9/L). Range 0-15 (the higher the score the better outcome).
- Assessing change in IWG (International Working Group) Criteria to evaluate response to Nerofe Treatment for MDS patients. A calculation of several variables.At every cycle on Day 1, Day 3, Day 8, Day 10, Day 12, D15, Day 17, Day 19, Day 22, Day 24, Day 26 and Day 28 (cycle length is 28 days), and at End of Treatment Visit, through study completion, an average of 1 year.
Complete Blood Count (CBC) to measure platelets (x10\^9/L). Range 0-2000 (the higher the score the better outcome).
- Assessing change in IWG (International Working Group) Criteria to evaluate response to Nerofe Treatment for MDS patients. A calculation of several variables.At every cycle on Day 1, Day 3, Day 8, Day 10, Day 12, D15, Day 17, Day 19, Day 22, Day 24, Day 26 and Day 28 (cycle length is 28 days), and at End of Treatment Visit, through study completion, an average of 1 year.
Complete Blood Count (CBC) to measure cytogenetic abnormalities. Range from very good (0) to very poor (4).
- Assessing change in ELN 2017 (European Leukemia Net) Criteria to evaluate response to Nerofe Treatment for AML patientsAt Screening (Day 1), at cycle 3 (Day 1) at cycle 5 (Day 1), at cycle 7 (Day 1), at cycle 9 (Day 1) at cycle 11 (Day 1) and at End of Treatment Visit. Cycle length is 28 days. Through study completion, an average of 1 year.
Bone Marrow samples to measure percentage of blasts (%). Range 0-30% (the higher percentage the worse outcome)
- Assessing change in ELN 2017 (European Leukemia Net) Criteria to evaluate response to Nerofe Treatment for AML patients. A calculation of several variables.At every cycle on Day 1, Day 3, Day 8, Day 10, Day 12, D15, Day 17, Day 19, Day 22, Day 24, Day 26 and Day 28 (cycle length is 28 days), and at End of Treatment Visit, through study completion, an average of 1 year.
Complete Blood Count (CBC) to measure absolute neutrophil count (x10\^9/L). Range 0-15 (the higher the score the better outcome)
- Assessing change in ELN 2017 (European Leukemia Net) Criteria to evaluate response to Nerofe Treatment for AML patients. A calculation of several variables.At every cycle on Day 1, Day 3, Day 8, Day 10, Day 12, D15, Day 17, Day 19, Day 22, Day 24, Day 26 and Day 28 (cycle length is 28 days), and at End of Treatment Visit, through study completion, an average of 1 year.
Complete Blood Count (CBC) to to measure platelets (x10\^9/L). Range 0-2000 (the higher the score the better outcome).
- Assessing change in ELN 2017 (European Leukemia Net) Criteria to evaluate response to Nerofe Treatment for AML patients. A calculation of several variables.At every cycle on Day 1, Day 3, Day 8, Day 10, Day 12, D15, Day 17, Day 19, Day 22, Day 24, Day 26 and Day 28 (cycle length is 28 days), and at End of Treatment Visit, through study completion, an average of 1 year.
Complete Blood Count (CBC) to measure cytogenetic abnormalities. Range from very good (0) to very poor (4).