RecruitingPhase 2NCT05365035

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


Sponsor

M.D. Anderson Cancer Center

Enrollment

60 participants

Start Date

Sep 23, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of chemotherapy drugs (cladribine, low-dose cytarabine, and venetoclax alternating with azacitidine and venetoclax) in people with higher-risk myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) — blood disorders where the bone marrow is not making healthy blood cells — that have not responded to or have relapsed after standard treatments. **You may be eligible if...** - You are 18 or older - You have been diagnosed with higher-risk MDS or CMML (as defined by WHO and risk scoring systems) - Your disease has either not responded to or has relapsed after standard hypomethylating agents (e.g., azacitidine or decitabine), OR you are newly diagnosed and not eligible for more intensive chemotherapy - Your organ function is within acceptable ranges **You may NOT be eligible if...** - You have a different type of leukemia - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding - You have active serious infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCladribine

Given by Vein (IV)

DRUGCytarabine

Given under the skin; subcutaneous injection (SQ)

DRUGVenetoclax

Given by PO

DRUGAzacitidine

Given by IV or subcutaneous injection (SQ)


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT05365035


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