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Acute Myeloid LeukemiaPhase 2NCT06232655

Cladribine Venetoclax in Monocytic AML

A Phase 2 study testing Cladribine, Venetoclax and Azacitidine in people with Acute Myeloid Leukemia, run by University of Colorado, Denver at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Investigation of Relapsed or refractory AML with a monocytic phenotype after failure of hypomethylating agent+venetoclax Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
Cladribine, Venetoclax and Azacitidine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
8 Feb 2024to Oct 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A subject will be eligible for study participation if they meet the following criteria within 28 days prior to the first day of treatment. Historical records are permitted per investigator discretion.
  • Subject must have confirmation of non-acute promyelocytic leukemia (APL) Acute Myeloid Leukemia (AML) with a monocytic or monoblastic phenotype or a Ras pathway mutation.
  • The subject's AML must be relapsed after or refractory to prior treatment with hypomethylating agent (HMA) and venetoclax combination.
  • Note: other prior line(s) of therapy including stem cell transplant (SCT) are allowed, but HMA/Ven must be one of the preceding treatments. Subjects who have progressed to AML after prior treatment with HMA/Ven for high grade Chronic Myelomonocytic Leukemia (CMML) or Myelodysplastic Syndrome (MDS) are also eligible.
  • Age ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
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  • Adequate renal function as demonstrated by a calculated creatinine clearance ≥ 60 mL/min, calculated using the formula CKD-EPI Creatinine Equation (2021).
  • Adequate liver function, as demonstrated by:
  • 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
  • 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).
  • 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.
  • 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.

Who cannot join

  • Subject has received prior treatment with cladribine for AML.
  • Subject has a white blood cell count > 25 x 109/L. Note: hydroxyurea and/or leukapheresis are permitted to meet this criterion.
  • Subject has known active central nervous system (CNS) involvement of AML.
  • Subject exhibits evidence of uncontrolled systemic infection requiring therapy (viral, bacterial, or fungal). Uncontrolled is defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment. Patients on antibiotics, antivirals, or antifungals with controlled systemic symptoms will not be excluded.
  • Subject has any clinically significant condition(s) that in the opinion of the investigator would adversely affect his/her participating in this study, including but not limited to:
  • New York Heart Association heart failure > class 2
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  • Renal, neurologic, psychiatric, endocrine, metabolic, immunologic, hepatic, cardiovascular disease, or bleeding disorder independent of leukemia.
  • Subject has a QTc interval > 470 msec.
  • 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
  • Subject is pregnant or breastfeeding.
  • Subject is known to be positive for HIV. HIV testing is not required.
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Universtiy of Colorado Hospital

    Aurora, Colorado, 80045

Other trials in United States

About this study

Official title: Study of Cladribine+Venetoclax After Failure of Venetoclax+Hypomethylating Agent in Monocytic AML

Investigation of Relapsed or refractory AML with a monocytic phenotype after failure of hypomethylating agent+venetoclax

Read the detailed description

This is an investigator-initiated, open label, single institution, Study to assess the efficacy of Clad/Ven following failure of HMA/Ven in AML with a monocytic phenotype. In cycle 1, subjects will receive cladribine at a dose of 5mg/m2 daily via intravenous infusion on days 1 through 5 and venetoclax 400mg daily (following standard dose escalation over the first 3 days) on days 1 through 28 of a 28 day cycle. A bone marrow biopsy will be performed to assess response on day 28 of cycle 1. Subjects who respond to cycle 1, defined as achieving a CR, CRi, MLFS, or PR per ELN criteria, or a blast reduction of at least 50% from baseline, may continue on alternating 28-day consolidation cycles of Aza/Ven (even cycles) and Clad/Ven (odd cycles). Cycles will continue unless the subject needs to be removed from the study due to disease progression, treatment failure (defined as failure to achieve CR, CRi, or MLFS after 4 cycles of treatment), intolerance or toxicity, patient preference, or other reasons.

Being tested
Cladribine, Venetoclax, Azacitidine
Keywords
Relapsed, Refractory
Medical subject headings
Leukemia, Myeloid, Acute, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CladribineDrug

    Also called Mavenclad, Leustatin

    A medication used to treat hairy cell leukemia (leukemic reticuloendotheliosis) and B-cell chronic lymphocytic leukemia. Cladribine, sold under the brand name Mavenclad, is used for the treatment of adults with highly active forms of relapsing-remitting multiple sclerosis.

  • VenetoclaxDrug

    Also called Venclyxto

    A medication used to treat adults with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or acute myeloid leukemia (AML).

  • AzacitidineDrug

    Also called Vidaza, Onureg

    Medication used for the treatment of myelodysplastic syndrome, myeloid leukemia, and juvenile myelomonocytic leukemia. It is a chemical analog of cytidine, a nucleoside in DNA and RNA.. Azacitidine and its deoxy derivative, decitabine were first synthesized in Czechoslovakia as potential chemotherapeutic agents for cancer.

Study groups in NCT06232655
Study groupRoleWhat they receive
Cladribine plus VenetoclaxExperimentalSubjects will receive cladribine at a dose of 5mg/m2 daily via intravenous infusion on days 1 through 5 of a 28 day cycle. Concomitantly, venetoclax will be administered orally at a dose of 100mg on day 1, 200mg on day 2, and 400mg daily on days 3 through 28.
Receives: Drug: Cladribine; Drug: Venetoclax
Alternating Aza/Ven and Clad/VenExperimentalAlternating 28-day consolidation cycles of Aza/Ven (even cycles) and Clad/Ven (odd cycles), while those who do not respond will come off the study.
Receives: Drug: Cladribine; Drug: Venetoclax; Drug: Azacitidine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate (ORR)

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

    Measured: End of Treatment, an average of 6 months

Secondary outcomes (5)

  1. Adverse Events

    Frequency of adverse events (AEs) and serious adverse events (SAEs)

    Measured: Duration of Treatment, an average of 6 months

  2. Event-free survival

    Event-free survival (EFS)

    Measured: Minimum of 3 years off study

  3. Overall survival

    Overall survival (OS)

    Measured: minimum of 3 years or off study

  4. Duration of response

    Duration of response (DOR)

    Measured: minimum of 3 years or off study

  5. Measurable residual disease

    Rate of measurable residual disease (MRD)-negativity

    Measured: Baseline through End of Treatment, an average of 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2024
  2. Study start8 Feb 2024
  3. Primary completion3 Jun 2026
  4. Study completionOct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06232655
Sponsor's protocol ID
23-0273.cc
Status last verified
Aug 2026
First submitted
19 Jan 2024
Last updated
25 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cladribine, Venetoclax and Azacitidine in people with Acute Myeloid Leukemia, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (ORR) (time frame: End of Treatment, an average of 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06232655.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.

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