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Acute Myeloid LeukemiaPhase 2NCT06351306

DEC-C and Thioguanine for R/R AML

A Phase 2 study testing Thioguanine (Tabloid ®) and DecitabineCedazuridine (Inqovi ®) in people with Acute Myeloid Leukemia, run by Columbia University.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to find out if oral decitabine-cedazuridine (Inqovi®) is effective, safe, and able to be tolerated without severe side effects when given with thioguanine (Tabloid®) in patients with acute myeloid leukemia (AML) whose disease has returned or did not respond to treatment (relapsed or… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
Thioguanine (Tabloid ®) and DecitabineCedazuridine (Inqovi ®)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
1 Apr 2024to 1 Apr 2024
Phase
Phase 2
Are there results?
None posted in the registry

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 of age
  • Patients must have histologically and cytologically confirmed R/R AML according to the World Health Organization classification based on documented bone marrow biopsy or peripheral blood specimens, with the exception of acute promyelocytic leukemia
  • Relapsed AML is defined as the detection of ≥5% blasts in the bone marrow or reappearance of leukemic blasts in the peripheral blood in a patient with prior remission
  • Refractory AML is defined as the failure to obtain a CR, CRh, or CRi after at least two courses of intensive induction (including hypomethylating agent plus venetoclax induction) or at least six cycles of a hypomethylating agent-based regimen (except venetoclax combinations as above)
  • Able to provide informed consent
  • Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2 or Karnofsky ≥60%
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  • Adequate organ function defined by the following parameters:
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5x the upper limit of normal (ULN)
  • Bilirubin ≤2x the ULN unless due to known Gilbert's disease or hemolysis due to blood transfusion
  • Calculated glomerular filtration rate (GFR) of ≥ 30 mL/min/1.73 m2
  • Prior hypomethylating agent is allowed
  • Female patients of childbearing potential must not be nursing or planning to become pregnant and require a negative urine or serum pregnancy test within 30 days of study therapy.
  • Female patients of childbearing potential must be willing to use at least 1 method of highly effective contraception during the study. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
  • Male patients treated or enrolled who are sexually active must agree to adequate contraception use and refrain from sperm donation throughout the duration of the study, and up to 4 months after completion of thioguanine and decitabine-cedazuridine.
  • Willing to provide pretreatment bone marrow aspirate and biopsies samples as well as subsequent bone marrow aspirate and biopsies samples during the study.
  • Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Previously received thioguanine
  • Any anti-leukemic therapy, including investigational therapies, within 14 days of study treatment initiation. Hydroxyurea for blood count control is allowed throughout induction cycle(s)
  • Prior allogeneic hematopoietic stem cell transplantation within 3 months of study enrollment; active graft versus host disease
  • Clinical suspicion for active central nervous system (CNS) involvement by AML; previously treated CNS involvement is allowed
  • Second malignancy requiring treatment within 6 months of study enrollment, with the exception of non-melanoma skin cancers or cancers requiring hormonal therapy only
  • Active, uncontrolled infection
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  • Human immunodeficiency virus (HIV) not controlled by standard therapy
  • Active hepatitis B or C infection. Participants whose infections are controlled with antiviral therapy are allowed.
  • Significant medical diseases or comorbidities, in the opinion of the investigator, that would preclude the safe participation in the study
  • Known hypersensitivity to DEC-C or thioguanine

About this study

Official title: A Phase II Open-Label, Single Center Trial of Oral Decitabine-Cedazuridine (DEC-C) (Inqovi®) in Combination With Thioguanine (Tabloid®) in Patients With Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML)

The purpose of this study is to find out if oral decitabine-cedazuridine (Inqovi®) is effective, safe, and able to be tolerated without severe side effects when given with thioguanine (Tabloid®) in patients with acute myeloid leukemia (AML) whose disease has returned or did not respond to treatment (relapsed or refractory).

This is a "phase II trial with a safety lead-in." The goal of the lead-in portion of the study is to make sure participants are getting the highest dose of medications that are safe. If too many serious side effects are seen with the dose previously studied, some additional patients may be treated with a lower dose to make sure that this dose is safe.

Read the detailed description

Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow with a 5-year survival rate of 47.5% for patients less than age 65 years and only an 8.2% survival for those 65 and older, based on data from the Surveillance, Epidemiology, and End Results (SEER) program of the National Cancer Institute. Despite some advances in treatment, most patients will relapse, and treatment remains limited, especially for patients that progress on the standard of care. The expected response rate to salvage chemotherapy is only 10-20% with a median survival typically of less than 6 months. The need for new, effective, and well-tolerated treatments is clear.

Being tested
Thioguanine (Tabloid ®), DecitabineCedazuridine (Inqovi ®)
Keywords
Myeloid Neoplasm, Cancer
Medical subject headings
Leukemia, Myeloid, Acute, Neoplasms

What participants receive

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

  • Thioguanine (Tabloid ®)Drug

    60-80mg/m^2 oral tablet

  • DecitabineCedazuridine (Inqovi ®)Drug

    35 mg decitabine and 100 mg cedazuridine oral tablet

Study groups in NCT06351306
Study groupRoleWhat they receive
Safety Lead-InExperimentalGroups of participants will receive different doses of thioguanine and decitabine-cedazuridine to identify the highest doses that can be given safely. The highest doses that are safe will then be used in the phase II portion of the clinical trial. If no dose is found to be safe, the study will be stopped. A phase II expansion cohort will be enrolled to further explore the combination's anti-leukemia activity and safety and will proceed at the maximum tolerated dose defined in the initial Safety Cohort.
Receives: Drug: Thioguanine (Tabloid ®); Drug: DecitabineCedazuridine (Inqovi ®)

What is being measured

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

  1. Composite Complete Remission (CRc) Rate

    This rate will be calculated from rate of complete remission (CR) plus CR with partial hematologic recovery (CRh) plus CR with incomplete hematologic recovery (CRi), according to the European LeukemiaNet (ELN) 2022 criteria.

    Measured: Up to 3 years

Secondary outcomes (3)

  1. Duration of Remission

    This is defined as the time from CRc until relapse or death from any cause, whichever is first.

    Measured: Up to 3 years

  2. Time to Complete Remission (CR)

    This is defined as time from therapy initiation until CRc.

    Measured: Up to 3 years

  3. Overall Survival (OS)

    This is defined as the duration of time from randomization to death from any cause.

    Measured: Up to 3 years

Timeline

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

  1. First posted8 Apr 2024
  2. Study start1 Apr 2024
  3. Primary completion1 Apr 2024
  4. Study completion1 Apr 2024

Why it stopped: Difficultly enrolling

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06351306
Sponsor's protocol ID
AAAU5915
Status last verified
Mar 2025
First submitted
2 Apr 2024
Last updated
24 Mar 2025
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 Thioguanine (Tabloid ®) and DecitabineCedazuridine (Inqovi ®) in people with Acute Myeloid Leukemia, run by Columbia University.

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 16 inclusion and 10 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: withdrawn, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Composite Complete Remission (CRc) Rate (time frame: Up to 3 years). 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 NCT06351306.

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 24 Mar 2025.

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