OncoMatch/Clinical Trials/NCT05365035
A Phase II Study of Cladribine and Low Dose Cytarabine in Combination With Venetoclax, Alternating With Azacitidine and Venetoclax, in Patients With Higher-risk Myeloproliferative Chronic Myelomonocytic Leukemia or Higher-risk Myelodysplastic Syndromes With Excess Blasts
Is NCT05365035 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Cladribine and Cytarabine for myelodysplastic syndromes.
Treatment: Cladribine · Cytarabine · Venetoclax · Azacitidine — To learn if the combination of cladribine, cytarabine, venetoclax, and azacitidine can help to control higher-risk myelodysplastic syndrome (MDS) with excess blasts and/or higher-risk chronic myelomonocytic leukemia (CMML).
Check if I qualifyExtracted eligibility criteria
Cancer type
Myelodysplastic Syndrome
Acute Myeloid Leukemia
Biomarker criteria
Allowed: ASXL1 high risk mutation
high risk mutations (ASXL1, RUNX1, SETBP1, BRAF, NRAS, KRAS, PTPN11, NF1, CBL)
Allowed: RUNX1 high risk mutation
high risk mutations (ASXL1, RUNX1, SETBP1, BRAF, NRAS, KRAS, PTPN11, NF1, CBL)
Allowed: SETBP1 high risk mutation
high risk mutations (ASXL1, RUNX1, SETBP1, BRAF, NRAS, KRAS, PTPN11, NF1, CBL)
Allowed: BRAF high risk mutation
high risk mutations (ASXL1, RUNX1, SETBP1, BRAF, NRAS, KRAS, PTPN11, NF1, CBL)
Allowed: NRAS high risk mutation
high risk mutations (ASXL1, RUNX1, SETBP1, BRAF, NRAS, KRAS, PTPN11, NF1, CBL)
Allowed: KRAS high risk mutation
high risk mutations (ASXL1, RUNX1, SETBP1, BRAF, NRAS, KRAS, PTPN11, NF1, CBL)
Allowed: PTPN11 high risk mutation
high risk mutations (ASXL1, RUNX1, SETBP1, BRAF, NRAS, KRAS, PTPN11, NF1, CBL)
Allowed: NF1 high risk mutation
high risk mutations (ASXL1, RUNX1, SETBP1, BRAF, NRAS, KRAS, PTPN11, NF1, CBL)
Allowed: CBL high risk mutation
high risk mutations (ASXL1, RUNX1, SETBP1, BRAF, NRAS, KRAS, PTPN11, NF1, CBL)
Allowed: TP53 high risk cytogenetic or molecular feature
high risk cytogenetic or molecular features (ASXL1, SETBP1, i(17q), TP53)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: investigational agent
Patients receiving any other concurrent investigational agent
Cannot have received: chemotherapy
Patients receiving any other concurrent...chemotherapy
Cannot have received: radiotherapy
Patients receiving any other concurrent...radiotherapy
Cannot have received: immunotherapy
Patients receiving any other concurrent...immunotherapy
Lab requirements
Kidney function
creatinine clearance > 30 ml/min, no end/stage renal disease (using Cockcroft-Gault)
Liver function
total bilirubin 2x ULN, AST or ALT 2.5 xULN unless deemed to be due to underlying disease involvement
Cardiac function
NYHA Class III or IV congestive heart failure or LVEF <50% by echocardiogram or MUGA scan excluded; history of myocardial infarction within the last 6 months or unstable/uncontrolled angina pectoris or history of severe and/or uncontrolled ventricular arrhythmias excluded
Creatinine clearance > 30 ml/min no end/stage renal disease (using Cockcroft-Gault). Adequate hepatic function with total bilirubin 2x ULN, AST or ALT 2.5 xULN unless deemed to be due to underlying disease involvement. NYHA Class III or IV congestive heart failure or LVEF <50% by echocardiogram or MUGA scan excluded; history of myocardial infarction within the last 6 months or unstable/uncontrolled angina pectoris or history of severe and/or uncontrolled ventricular arrhythmias excluded.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- M D Anderson Cancer Center · Houston, Texas
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