OncoMatch/Clinical Trials/NCT06199557
A Study to Investigate Treatment of HU and VPA, or 6-MP and VPA in Unfit AML/HR-MDS Patients
Is NCT06199557 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Hydroxyurea, Hydroxycarbamide and Valproic acid for acute myeloid leukemia, adult.
Treatment: Hydroxyurea, Hydroxycarbamide · Valproic acid · 6-Mercaptopurine (6-MP) — The purpose of this study is to investigate the safety, tolerability, and preliminary efficacy of the combination treatment of hydroxyurea capsules and valproic acid capsules, or the combination treatment of 6-mercaptopurine tablets and valproic acid capsules in male and female patients aged 18 years or older with acute myeloid leukemia or high- risk myelodysplastic syndrome. The population to be studied is newly diagnosed AML patients who are considered unfit for standard induction chemotherapy, HR-MDS unfit/ineligible for standard treatment, and relapsed/refractory AML/HR-MDS patients who are considered unfit for standard therapy ,or are, for some reason, ineligible for another type of therapy. Clinically, hydroxyurea, valproic acid and 6-mercaptopurine are historically very well-known therapeutic agents with low toxicity profiles. The rationale for this study is that the combination of these drugs with low toxicity will be well tolerated in elderly AML patients with comorbidities, or lower performance status. This combination could have a beneficial therapeutic effect on overall survival and contribute to a better quality of life.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Performance status
ECOG 0–3(Limited self-care)
Prior therapy
Cannot have received: anti-leukemic therapy
Patients on treatment for AML (any anti-leukemic therapy including investigational agents) or treated less than 2 weeks before inclusion.
Lab requirements
Kidney function
Serum creatinine ≤1.5 x ULN; estimated creatinine clearance ≥ 40 mL/min (Cockcroft-Gault equation)
Liver function
Serum bilirubin ≤ 1.5 x ULN; AST ≤2.5 × ULN (≤5 × ULN for patients with liver metastases); ALT ≤2.5 × ULN (≤5 × ULN for patients with liver metastases); ALP ≤2.5 × ULN
Cardiac function
No myocardial infarction within the last 3 months, no congestive heart failure NYHA class IV, no unstable angina, no unstable cardiac arrhythmias
Adequate renal and hepatic functions unless clearly disease related as indicated by the following laboratory values: Serum creatinine ≤1.5 x ULN; Estimated creatinine clearance ≥ 40 mL/min (Cockcroft-Gault equation); Serum bilirubin ≤ 1.5 x ULN; AST ≤2.5 × ULN (≤5 × ULN for patients with liver metastases); ALT ≤2.5 × ULN (≤5 × ULN for patients with liver metastases); ALP ≤2.5 × ULN. Cardiac dysfunction as defined by: myocardial infarction within the last 3 months of study entry, or congestive heart failure NYHA class IV or unstable angina, or unstable cardiac arrhythmias
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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