Actively Recruiting
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
Led by M.D. Anderson Cancer Center · Updated on 2025-12-31
60
Participants Needed
1
Research Sites
275 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Diagnosis of myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) confirmed by WHO criteria
- For relapsed MDS: Intermediate-2 or High risk IPSS-R score above 3.5 and more than 5% blasts, with no response or relapse after prior hypomethylating agent therapy
- For relapsed CMML: CMML-1 or CMML-2 with no response or relapse after hypomethylating agent therapy
- For MDS HMA-naive: Intermediate-2 or High risk IPSS-R score above 3.5 and at least 10% blasts
- For CMML HMA-naive: CMML-2 or CMML-1 with high-risk features such as extramedullary disease, significant splenomegaly, low platelets, low hemoglobin, high white blood cell count, or specific genetic abnormalities
- For MDS/MPN relapsed: MDS/MPN with more than 5% blasts and no response or relapse after hypomethylating agent therapy
- For MDS/MPN HMA-naive: MDS/MPN with at least 10% blasts or at least 5% blasts plus high-risk features like splenomegaly, high white blood cell count, or high-risk genetic markers
- ECOG performance status of 0 to 2
- Creatinine clearance above 30 ml/min without end-stage kidney disease
- Adequate liver function with total bilirubin less than twice the upper limit of normal and AST or ALT less than 2.5 times the upper limit unless due to underlying disease
- Willingness to comply with study requirements and restrictions
- Signed informed consent document
- English and non-English speaking patients are eligible
You will not qualify if you...
- Uncontrolled infection not responding to antibiotics
- Congestive heart failure New York Heart Association Class III or IV or left ventricular ejection fraction below 50%
- History of heart attack within 6 months, unstable chest pain, or severe uncontrolled heart rhythm problems
- Pregnant or breastfeeding female patients
- Patients with reproductive potential unwilling to follow contraception requirements during the study
- Female patients of reproductive potential without a negative pregnancy test at screening
- Receiving any other investigational drug, chemotherapy, radiotherapy, or immunotherapy concurrently
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
G
Guillermo Bravo, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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