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Cladribine and Venetoclax for Monocytic AML

This study is looking at a new way to treat Acute Myeloid Leukemia (AML) that has a specific monocytic (a type of white blood cell) feature or a Ras pathway mutation. It's for people whose AML has come back or didn't respond to previous treatment with a hypomethylating agent and venetoclax. The study will test a combination of two drugs, cladribine and venetoclax, to see how well they work. If you respond well after the first cycle, you might continue with alternating cycles of azacitidine and venetoclax, and cladribine and venetoclax. Doctors will measure how many people respond to the treatment to see if it's successful. The study plans to enroll 20 participants aged 18 to 100 years old. The current recruitment status is unclear.

Study design
This is an open-label study, meaning you and your doctors will know which treatments you are receiving. It is a single-institution study, and it plans to enroll 20 participants.
What's involved
You would receive cladribine and venetoclax for 28-day cycles. A bone marrow biopsy will be done after the first cycle to check your response. If you respond, you will continue with alternating 28-day cycles of azacitidine and venetoclax, and cladribine and venetoclax.
Compensation
Not stated in the trial record.
Follow-up
Your response to treatment will be measured at the end of treatment, which is an average of 6 months.

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

NCT06232655

Cladribine Venetoclax in Monocytic AML

Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Colorado, Denver
~10 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:CladribineVenetoclaxAzacitidine

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall response rate (ORR)
Measured over End of Treatment, an average of 6 months

Conditions

Acute Myeloid Leukemia

Explore related trials

Acute Myeloid LeukemiaRAS Family Oncogene

Where it's being run

1 sites across 1 states
Colorado1

Study leadership

  • Christine McMahon, MD · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Aspartate aminotransferase (AST) ≤ 3.0 x ULN\*
Alanine aminotransferase (ALT) ≤ 3.0 x ULN\*
Total bilirubin ≤ 1.5 x ULN, unless considered to be due to leukemic organ involvement or Gilbert's syndrome\* \*In subjects with Gilbert's syndrome, bilirubin needs to be ≤ 4 x ULN 6. Non-sterile male subjects must use contraceptive methods with partner(s) at least prior to beginning study drug administration and continuing up to 90 days after the last dose of study drug. Male subjects must agree to refrain from sperm donation from initial study drug administration until 90 days after the last dose of study drug. No contraception is required if male subjects are surgically sterile (vasectomy with medical assessment confirming surgical success) or if the male subject has a female partner who is postmenopausal or permanently sterile (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy). 7. Female subjects must be either:
Postmenopausal: defined as age \> 60 years with no menses for 12 or more months without an alternative medical cause; OR
Permanently surgically sterile (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy); OR
If subject is of childbearing potential, use of contraception is required while on study treatment and for 6 months after the last dose. 8. Subject must voluntarily sign an informed consent, approved by the Institutional Research Board (IRB), prior to the initiation of any research-related screening or study procedures.

Exclusion

New York Heart Association heart failure \> class 2
Renal, neurologic, psychiatric, endocrine, metabolic, immunologic, hepatic, cardiovascular disease, or bleeding disorder independent of leukemia. 6. Subject has a QTc interval \> 470 msec. 7. Subject has a history of other malignancies within 2 years prior to study entry, with the following exceptions:
Adequately treated in situ carcinoma of the breast or cervix
Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin
Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent
Prostate cancer not requiring therapy beyond hormonal therapy 8. Subject is pregnant or breastfeeding. 9. Subject is known to be positive for HIV. HIV testing is not required. 10. Subject is known to be positive for hepatitis B or C infection with the exception of those with an undetectable viral load. Hepatitis B or C testing is not required, and subjects with serologic evidence of prior vaccination to HBV may participate.

What this trial measures

  • Overall response rate (ORR)End of Treatment, an average of 6 months

    Defined as the proportion of subjects who achieve a CR, CRi, or MLFS that is relapsed after or refractory to HMS/Ven