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Study of Cladribine, Cytarabine, Venetoclax, and Azacitidine for Higher-Risk MDS and CMML

This study is testing if a combination of medicines can help people with higher-risk myelodysplastic syndromes (MDS) with excess blasts or higher-risk chronic myelomonocytic leukemia (CMML). You would receive cladribine, cytarabine, and venetoclax, alternating with azacitidine and venetoclax. Researchers want to see if these treatments improve how long people live (overall survival). This study is for adults aged 18 and older who have these conditions, especially if their disease has not responded to previous treatments or has progressed. The study is currently recruiting about 60 participants.

Study design
This interventional study is designed to evaluate the effectiveness and safety of the drug combinations. It plans to enroll 60 participants across different groups based on their specific condition and prior treatment.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure overall survival through study completion, which is an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~60 participants
Updated 2026-06-05 on ClinicalTrials.gov
What's tested:CladribineCytarabineVenetoclaxAzacitidine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To establish the overall survival (OS).
Measured over through study completion, an average of 1 year

Conditions

Myelodysplastic Syndromes
Myeloproliferative Chronic Myelomonocytic Leukemia

Explore related trials

Atypical Chronic Myeloid LeukemiaChronic Myelomonocytic LeukemiaMiller-Dieker SyndromeMyelodysplastic Syndrome

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Guillermo Bravo, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Guillermo Bravo, MD
[email protected]
(713) 794-3604
Email the study team

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Eligibility criteria

Inclusion

MDS relapsed cohort (Cohort A): MDS with IPSS-R score \>3.5 and \>5% blasts with no response after 6 cycles of azacitidine, decitabine, guadecitabine or ASTX727 (decitabine/cedazuridine) or relapse or progression after any number of cycles
CMML relapsed cohort (Cohort B): CMML 1 or 2 with no response after 6 cycles of azacitidine, decitabine, guadecitabine or ASTX727 (decitabine/cedazuridine) or relapse or progression after any number of cycles
MDS HMA-naïve cohort (Cohort C): MDS with IPSS-R score \>3.5 and \>/= 10% blasts
CMML HMA-naïve cohort (Cohort D): CMML-2; OR CMML-1 with at least one of the following high-risk features: extramedullary disease, splenomegaly of \>5cm below costal margin or by sonographic volumetric assessment, platelets \<100x109/L, Hgb level \<10g/dL, WBC \>13x109/L, clonal cytogenetic abnormality (other than monosomy Y) or high risk mutations (ASXL1, RUNX1, SETBP1, BRAF, NRAS, KRAS, PTPN11, NF1, CBL).
MDS/MPN relapsed cohort (Cohort E): MDS/MPN-NOS, MDS/MPN with neutrophilia (atypical CML) or MDS/MPN-RS-T with \>5% blasts with no response after 6 cycles of azacitidine, decitabine, guadecitabine or ASTX727 (decitabine/cedazuridine) or relapse or progression after any number of cycles
MDS/MPN HMA-naïve cohort (Cohort F): MDS/MPN-NOS or MDS/MPN with neutrophilia (atypical CML) with
\>/=10% blasts or
with \>5% blasts at least one of the following high-risk features: splenomegaly \>5cm below costal margin, WBC \>13x109/L, high risk cytogenetic or molecular features (ASXL1, SETBP1, i(17q), TP53) or
who might not be deemed to benefit from HMA therapy due to proliferative or extramedullary disease. 3. Eastern Cooperative Oncology Group (ECOG) performance status of \</= 2 4. Creatinine clearance \> 30 ml/min no end/stage renal disease (using Cockcroft-Gault) 5. Adequate hepatic function with total bilirubin 2x ULN, AST or ALT 2.5 xULN unless deemed to be due to underlying disease involvement. 6. Willing to adhere to and comply with all prohibitions and restrictions specified in the protocol. 7. Patient must have signed an informed consent document indicating that the patient understands the purpose of and procedures required for the study and is willing to participate in the study. 8. English and Non-English speaking patients will be allowed

What this trial measures

  • To establish the overall survival (OS).through study completion, an average of 1 year