AzTrials
AzTrials

Recurrent Acute Myeloid LeukemiaPhase 2NCT05799079

Decitabine and Cedazuridine in Combination With Venetoclax for the Treatment of Patients Who Have Relapsed Acute Myeloid Leukemia After Donor Stem Cell Transplant

A Phase 2 study testing Venetoclax, Decitabine and Cedazuridine in people with Recurrent Acute Myeloid Leukemia, run by Sanjay Mohan at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This phase II trial tests how well decitabine and cedazuridine (DEC-C) works in combination with venetoclax in treating acute myeloid leukemia (AML) in patients whose AML has come back after a period of improvement (relapse) after a donor stem cell transplant. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent Acute Myeloid Leukemia
What is being tested?
Venetoclax, Decitabine and Cedazuridine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteUnited States
Study dates
13 Apr 2023to 20 Sep 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age >= 18 years at the time of signing the Informed Consent Form (ICF); must voluntarily sign an ICF and meet all study requirements
  • History of morphologically confirmed AML (per World Health Organization [WHO] diagnostic criteria) with evidence of disease recurrence (>= 5% blasts consistent with prior disease) that occurs after allogeneic hematopoietic cell transplantation (HCT). Patients transplanted for another indication (e.g., myelodysplastic syndrome/chronic myelomonocytic leukemia [MDS/CMML]) who relapse with AML are eligible to enroll
  • White blood cells (WBC) must be less than 25,000/ul for at least three days prior to cycle 1, day 1 (C1D1) (hydroxyurea allowed)
  • A bone marrow biopsy must be performed and tissue collected for entrance to the trial
  • Eastern Cooperative Oncology Group Performance Status of 0 - 2
  • Alanine transaminase (ALT) serum glutamic pyruvic transaminase (SGPT) and/or aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT) less than or equal to 3x upper limit of normal (ULN)
Show all 10Show fewer
  • Total bilirubin < 1.5 x ULN
  • Patients with Gilbert's syndrome (hereditary indirect hyperbilirubinemia) must have a total bilirubin of < 3 x ULN
  • Calculated creatinine clearance >= 30 ml/min (per the Cockroft-Gault formula)
  • Willingness to abide by all study requirements, including contraception, maintenance of a pill diary, and acceptance of recommended supportive care medications

Who cannot join

  • Prior relapse or progression while receiving venetoclax or other commercially available or investigational BCL-2 inhibitor
  • Anticancer therapy, including investigational agents =< 2 weeks or =< 5 half-lives of the drug, whichever is shorter, prior to C1D1. (Use of hydroxyurea is permitted)
  • Inadequate recovery from toxicity attributed to prior anti-cancer therapy to =< Grade 1 (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version [v]5.0), excluding alopecia or fatigue
  • History of allogeneic HCT, or other cellular therapy product, within 3 months of signing consent
  • Clinically active acute or chronic graft versus host disease (GVHD). Patients must be off calcineurin inhibitors for at least 4 weeks to be eligible
  • Radiation therapy or major surgery within 3 weeks of signing consent
Show all 15Show fewer
  • Active, uncontrolled infection. Patients with infection under active treatment and controlled with antibiotics are eligible. Prophylaxis is acceptable
  • Inability to tolerate oral medication, presence of poorly controlled gastrointestinal disease, or dysfunction that could affect study drug absorption
  • Active documented central nervous system leukemia
  • Concurrent treatment with a non-permitted concomitant medication
  • Other malignancy IF currently being treated or likely to be treated in next 6 months except for basal or squamous cell carcinoma of the skin or cervical carcinoma in situ
  • Pregnancy or breastfeeding females
  • Known chronic alcohol or drug abuse
  • Clinically significant cardiovascular disease with major event or cardiac intervention within the past 6 months (e.g. percutaneous intervention, coronary artery bypass graft, documented cardiac heart failure) as determined by the investigator
  • Any other condition deemed by the investigator to make the patient a poor candidate for clinical trial and/or treatment with investigational agents

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232

Other trials in United States

About this study

Official title: Phase 2 Study of Decitabine and Cedazuridine in Combination With Venetoclax for AML Relapse After Allogeneic Hematopoietic Cell Transplantation

This phase II trial tests how well decitabine and cedazuridine (DEC-C) works in combination with venetoclax in treating acute myeloid leukemia (AML) in patients whose AML has come back after a period of improvement (relapse) after a donor stem cell transplant. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving DEC-C in combination with venetoclax may kill more cancer cells in patients with relapsed AML.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To assess the effect of DEC-C/venetoclax on the investigator-assessed composite complete remission (CR) rate (CR/complete remission with partial hematologic recovery [CRh]/complete remission with incomplete hematologic recovery [CRi]).

SECONDARY OBJECTIVES:

  1. To assess the rate of partial response (PR) and morphologic leukemia free state (MLFS) following treatment with DEC-C/venetoclax. II. To assess the relapse free survival of patients treated with DEC-C/venetoclax.

III. To assess overall survival of patients treated with DEC-C/venetoclax. IV. To assess the safety and tolerability of DEC-C/venetoclax in the post-hematopoietic cell transplant (HCT) setting.

  1. To assess the rates of measurable residual disease negativity in patients achieving a CR.

OUTLINE:

Patients receive venetoclax orally (PO) daily for 28 days in a 28-day cycle. Patients receive DEC-C PO daily on days 1-5 of a 28-day cycle. Patients undergo bone marrow biopsy and aspiration and blood sample collection throughout the study.

Being tested
Venetoclax, Decitabine, Cedazuridine, Bone Marrow Aspiration and Biopsy, Biospecimen Collection
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

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

  • VenetoclaxDrug

    Given by mouth

  • DecitabineDrug

    Given by mouth

  • CedazuridineDrug

    Given by mouth

  • Bone Marrow Aspiration and BiopsyProcedure or surgery

    Undergo bone marrow biopsy

  • Biospecimen CollectionProcedure or surgery

    Undergo blood sample collection

Study groups in NCT05799079
Study groupRoleWhat they receive
Treatment (Venetoclax, DEC-C)ExperimentalPatients receive venetoclax PO daily for 28 days in a 28-day cycle. Patients receive DEC-C PO daily on days 1-5 of a 28-day cycle. Patients undergo bone marrow biopsy and aspiration and blood sample collection throughout the study.
Receives: Drug: Venetoclax; Drug: Decitabine; Drug: Cedazuridine; Procedure: Bone Marrow Aspiration and Biopsy; Procedure: Biospecimen Collection

What is being measured

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

  1. Number of Participants That Achieved a Complete Response to Therapy

    Measured: 9 months

Secondary outcomes (6)

  1. Number of Participants That Achieved a Partial Response to Therapy

    Measured: 9 months

  2. Rate of Morphologic Leukemia Free State (MLFS) Following Treatment With DEC-C/Venetoclax

    Measured: Up to 24 months post-treatment.

  3. Rate of Relapse Free Survival

    Relapse free survival was estimated by the Kaplan-Meier Method

    Measured: Up to 24 months post-treatment.

  4. Rate of Overall Survival

    Overall survival was estimated using the Kaplan-Meier method.

    Measured: Up to 24 months post-treatment.

  5. Number of Treatment-related Adverse Events

    List of adverse events that were attributed as related to study treatment is reported. All occurrences of a particular adverse event is reported.

    Measured: The one patient that was enrolled on the study was on treatment for 3 months and adverse event data were followed during treatment and 35 days after completing treatment.

  6. Rate of Measurable Residual Disease Negativity in Patients Achieving a CR

    Measured: Up to 24 months post-treatment.

Timeline

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

  1. First posted5 Apr 2023
  2. Study start13 Apr 2023
  3. Primary completion20 Sep 2024
  4. Study completion20 Sep 2024

Why it stopped: Study was terminated early due to lack of accrual and loss of funding.

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05799079
Sponsor's protocol ID
VICCHEM2163
Status last verified
Sep 2025
First submitted
22 Mar 2023
Last updated
9 Jan 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Venetoclax, Decitabine and Cedazuridine in people with Recurrent Acute Myeloid Leukemia, run by Sanjay Mohan 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 10 inclusion and 15 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: stopped early, as of the sponsor's last update on 9 Jan 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?

Yes. Results are posted in the registry (first posted 9 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants That Achieved a Complete Response to Therapy (time frame: 9 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 NCT05799079.

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 9 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in