OncoMatch/Clinical Trials/NCT06397313
RVU120 in Patients With Intermediate or High-risk, Primary or Secondary Myelofibrosis
Is NCT06397313 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including RVU120 and Ruxolitinib for myelofibrosis.
Treatment: RVU120 · Ruxolitinib — The objective of this clinical trial is to evaluate the efficacy (how well the drug works), safety, pharmacokinetics (PK), and pharmacodynamics (PD) of the study drug, RVU120, in treating adult patients with intermediate or high-risk, primary or secondary myelofibrosis. RVU120 will be given as a single agent or in combination with ruxolitinib.
Check if I qualifyExtracted eligibility criteria
Cancer type
Myeloproliferative Neoplasm
Disease stage
Required: Stage INTERMEDIATE RISK, HIGH RISK (WHO)
Intermediate or high-risk disease.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: Janus kinase (JAK) inhibitor
Resistant or refractory to prior Janus kinase (JAK) inhibitor treatment or ineligible for JAK inhibitor treatment in the opinion of the investigator; or Suboptimal response to JAK inhibitor treatment. ... or may include participants naïve to previous treatment with JAK inhibitor.
Cannot have received: hematopoietic stem cell transplant
Prior history of hematopoietic stem cell transplant.
Lab requirements
Blood counts
ANC ≥1.0 × 10^9/L (without growth factor support); platelet count ≥50 × 10^9/L (Cohort 2 and Cohort 3 only).
Kidney function
Creatinine clearance (CrCl) of ≥30 mL/minute using Cockcroft and Gault formula.
Liver function
AST and ALT ≤3 × ULN; ALP ≤2 × ULN (≤5 × ULN for bone isozymes); bilirubin <2 × ULN or ≤3 × ULN if due to Gilbert's disease.
Cardiac function
No significant cardiac dysfunction (myocardial infarction within 12 months, NYHA Class III or IV heart failure, uncontrolled dysrhythmias, poorly controlled angina, LVEF <40%). QTc <470 ms (Bazett's formula).
Adequate hematologic function defined as: absolute neutrophil count (ANC) ≥1.0 × 10^9/L (without growth factor support); platelet count ≥50 × 10^9/L (Cohort 2 and Cohort 3 only). Adequate renal function defined as calculated or measured creatinine clearance (CrCl) of ≥30 mL/minute using the formula of Cockcroft and Gault. Adequate liver function defined as (a) AST and ALT ≤3 × ULN; (b) ALP ≤2 × ULN (≤5 × ULN for bone isozymes); (c) bilirubin <2 × ULN or ≤3 × ULN if due to Gilbert's disease. Significant cardiac dysfunction defined as myocardial infarction within 12 months of Cycle 1 Day 1, NYHA Class III or IV heart failure, uncontrolled dysrhythmias, poorly controlled angina, or LVEF <40% as per echocardiography or MUGA scan. QTc ≥470 ms (Bazett's formula).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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