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Acute Myeloid LeukemiaPhase 2NCT01627041

Decitabine, Cytarabine, and Daunorubicin Hydrochloride in Treating Patients With Acute Myeloid Leukemia

A Phase 2 study testing Cytarabine, Daunorubicin Hydrochloride and Decitabine in people with Acute Myeloid Leukemia and Adult Acute Basophilic Leukemia, run by National Cancer Institute (NCI) at 9 sites 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

This randomized phase II trial studies how well decitabine works when given together with daunorubicin hydrochloride and cytarabine in treating patients with acute myeloid leukemia. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Cytarabine, Daunorubicin Hydrochloride and Decitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
178 participants
Where
9 sitesUnited States
Study dates
16 Sep 2011to 1 Feb 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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of acute myeloid leukemia (AML) as defined by the World Health Organization
  • Molecular AML-risk group is less-than-favorable as defined by any of the following criteria:
  • The absence of good-risk karyotype t(8;21), inv(16), t(16;16), or t(15;17)identified by metaphase karyotype
  • The absence of t(8;21), inv(16), t(16;16), or t(15;17) identified by fluorescent in situ hybridization(FISH)
  • The absence of the corresponding fusion transcripts, AML1-eight-twenty-one corepressor (ETO), core-binding factor, beta subunit (CBFβ)-smooth muscle myosin heavy chain (SMMHC), or progressive multifocal leukoencephalopathy (PML)-retinoic acid receptor alpha (RARa), identified by reverse transcriptase-polymerase chain reaction (RT-PCR)
  • Patient does not have acute promyelocytic leukemia (APL, French-American-British [FAB] M3)
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  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
  • Adequate cardiac function as defined by either of the following:
  • An echocardiogram demonstrating an ejection fraction within normal limits
  • A multi gated acquisition (MUGA) scan demonstrating an ejection fraction within normal limits
  • Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) ≤ 2.5 times institutional upper limit of normal (ULN)
  • Creatinine ≤ 2 mg/dL OR creatinine clearance ≥ 50 mL/min
  • Total bilirubin ≤ 2 times ULN
  • Patients with documented diagnosis of Gilbert syndrome resulting in elevated total bilirubin levels will be eligible, provided all other eligibility criteria are met
  • Patients with a total bilirubin of 2-3 mg/dL and direct (conjugated) bilirubin in the normal range will be eligible, provided all other eligibility criteria are met
  • Pregnant and nursing subjects may not be enrolled and pregnancy must be avoided; women of child-bearing potential-defined as a sexually active woman who has not undergone hysterectomy and who has had menses any time within the preceding 24 months-must have a negative serum or urine pregnancy test within 7 days prior to registration; women and men of childbearing potential must either commit to continued abstinence from heterosexual intercourse or commit to two acceptable methods of birth control-one highly effective method (e.g., IUD, oral or non-oral hormonal contraceptive, tubal ligation or partner's vasectomy) and one additional effective method (e.g., latex condom, diaphragm or cervical cap) at the same time from the time of screening through final Treatment Response Assessment
  • NOTE: should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, the subject should inform their treating phy-sician immediately
  • NOTE: the effects of decitabine on the developing human fetus are unknown but it is a know teratogen in mammals (mice)
  • Ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • Chemotherapy (other than hydroxyurea) or radiation within the 2 weeks prior to planned therapy on this study or ongoing adverse events due to agents administered more than 2 weeks earlier
  • Concurrent treatment with other investigational agents is not permitted
  • Cumulative lifetime dose of anthracycline chemotherapeutic > 80 mg/m^2
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition of decitabine, cytarabine or daunorubicin
  • Uncontrolled intercurrent illness considered by the investigator to constitute an unwarranted high risk for investigational drug treatment; examples include, but not limited to the following:
  • Uncontrolled serious infection; or
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  • Unstable angina pectoris; or
  • Uncontrolled cardiac arrhythmia; or
  • Active second malignancy requiring treatment; or
  • Symptomatic congestive heart failure
  • HIV-positive subjects with a CD4 count < 200 cells/μL are excluded due to the increased risk of lethal infections when treated with marrow-suppressive chemotherapy(87)
  • NOTE: subjects with HIV infection and a CD4 count >= 200 cells/μL are eligible but combination antiretroviral therapy should be held during administration of chemotherapy due to the potential for pharmacokinetic interactions with decita-bine, cytarabine or daunorubicin. Antiretroviral therapy may be resumed 24 hours after completion of the last dose of induction chemotherapy
  • Subject has a psychiatric disorder, altered mental status or social situation that would preclude understanding of the informed consent process and/or limit compliance with study requirements
  • Subject has an inability or unwillingness, in the opinion of the investigator, to comply with the protocol requirements
  • Subjects with central nervous system (CNS) (or leptomeningeal) infiltration by AML may be considered for treatment at the Investigator's discretion and following discussion with the Principle Investigator; all neurologic deficits must be noted prior to enrollment on study
  • Subject has circulating blast count > 50,000/μL (subjects may be enrolled if circulating blast count is controlled by hydroxyurea and/or, if clinically indicated, by leukophoresis)

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Lafayette Family Cancer Center-EMMC

    Brewer, Maine, 04412

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • NYP/Weill Cornell Medical Center

    New York, New York, 10065

  • Montefiore Medical Center-Weiler Hospital

    The Bronx, New York, 10461

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467

Other trials in United States

About this study

Official title: Randomized Phase II Study of Epigenetic Priming Using Decitabine With Induction Chemotherapy in Patients With Acute Myelogenous Leukemia (AML)

This randomized phase II trial studies how well decitabine works when given together with daunorubicin hydrochloride and cytarabine in treating patients with acute myeloid leukemia. Drugs used in chemotherapy, such as decitabine, daunorubicin hydrochloride, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Decitabine may help daunorubicin hydrochloride and cytarabine kill more cancer cells by making them more sensitive to the drugs. It is not yet known whether low-dose decitabine is more effective than high-dose decitabine when giving together with daunorubicin hydrochloride and cytarabine in treating acute myeloid leukemia.

Read the detailed description

OBJECTIVES: Primary I. To "Pick a Winner" by deciding whether further development of epigenetic priming with decitabine prior to standard "7+3" induction chemotherapy should be pursued.

Secondary I. To determine whether epigenetic priming with decitabine prior to standard cytarabine and daunorubicin hydrochloride "7+3" induction chemotherapy has sufficient efficacy to warrant further development as assessed by an overall CR1 rate ≥ 50%.

II. To establish the safety and expected toxicities of decitabine when used as priming for cytarabine and daunorubicin hydrochloride "7+3" induction chemotherapy in acute myeloid leukemia (AML).

III. To assess the pharmacodynamics of deoxyribonucleic acid (DNA) hypomethylation when decitabine is administered as a short infusion.

IV. To investigate, in selected cases, the molecular and cellular consequences of decitabine-induced hypomethylation by assessing the effects of decitabine-mediated hypomethylation on transcriptional patterns in AML cells, and by determining the effect of hypomethylation on the differentiation and/or apoptosis of leukemic blasts. (exploratory) V. To identify biomolecular correlates of treatment response (biomarkers) to induction chemotherapy in AML based upon the epigenetic pattern of DNA methylation in AML specimens obtained prior to treatment. (exploratory)

OUTLINE: This is a multicenter study. Patients are stratified according to age (less than 50 years vs 50-65 years), white blood cell count (≤ 30 K/mL vs greater than 30 K/mL), cytogenetic risk group (intermediate vs adverse risk), and antecedent hematological condition preceding the diagnosis of acute myeloid leukemia (yes vs no). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive induction chemotherapy comprising daunorubicin hydrochloride intravenously (IV) daily on days 1-3 and cytarabine IV continuously on days 1-7 in the absence of disease progression or unacceptable toxicity. Patients who do not achieve a complete remission (CR) after the first induction-chemotherapy course receive a second identical induction course.

Arm II: Patients receive decitabine IV over 1 hour on days -5 to -1. Patients then receive induction chemotherapy as in arm I in the absence of disease progression or unacceptable toxicity. Patients who do not achieve a CR after the first induction-chemotherapy course receive a second identical induction course.

Patients undergo blood, bone marrow, and oral mucosa cells sample collection at baseline, prior to induction therapy, and after treatment for DNA methylation studies and pharmacodynamic studies.

After completion of study treatment, patients are followed up for up to 10 years.

Being tested
Cytarabine, Daunorubicin Hydrochloride, Decitabine, Laboratory Biomarker Analysis, Pharmacological Study
Medical subject headings
Leukemia, Myeloid, Acute, Leukemia, Basophilic, Acute, Leukemia, Monocytic, Acute, Leukemia, Myelomonocytic, Acute

What participants receive

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

  • CytarabineDrug

    Also called .beta.-Cytosine arabinoside, 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-.beta.-D-Arabinofuranosylcytosine, 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone

    Given IV

  • Daunorubicin HydrochlorideDrug

    Also called Cerubidin, Cerubidine, Cloridrato de Daunorubicina, Daunoblastin

    Given IV

  • DecitabineDrug

    Also called 5-Aza-2'-deoxycytidine, Dacogen, Decitabine for Injection, Deoxyazacytidine

    Given IV

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Pharmacological StudyOther

    Correlative studies

Study groups in NCT01627041
Study groupRoleWhat they receive
Arm I (daunorubicin hydrochloride, cytarabine)ExperimentalPatients receive induction chemotherapy comprising daunorubicin hydrochloride IV daily on days 1-3 and cytarabine IV continuously on days 1-7 in the absence of disease progression or unacceptable toxicity. Patients who do not achieve a CR after the first induction-chemotherapy course receive a second identical induction course.
Receives: Drug: Cytarabine; Drug: Daunorubicin Hydrochloride; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study
Arm II (decitabine, daunorubicin hydrochloride, cytarabine)ExperimentalPatients receive decitabine IV over 1 hour on days -5 to -1. Patients then receive induction chemotherapy as in arm I in the absence of disease progression or unacceptable toxicity. Patients who do not achieve a CR after the first induction-chemotherapy course receive a second identical induction course.
Receives: Drug: Cytarabine; Drug: Daunorubicin Hydrochloride; Drug: Decitabine; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study

What is being measured

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

  1. Complete remission rate (CR1)

    Measured: After 1 course of decitabine-primed induction chemotherapy

Secondary outcomes (6)

  1. Complete remission rate (CR1 + CR2)

    Measured: After up to 2 courses of decitabine-primed induction chemotherapy

  2. Overall survival

    Measured: Time from entry on study to time of death from any cause, assessed up to 10 years

  3. Relapse-free survival

    Measured: Time from CR documentation to either AML relapse or death from any cause, assessed up to 10 years

  4. Event-free survival

    Measured: Time from entry on study until treatment failure (no CR with up to two study induction cycles), AML relapse, or death from any cause, assessed up to 10 years

  5. Time to complete response determined according to the International Working Group (IWG) criterion

    95% confidence limits will be provided.

    Measured: Time from entry on study until documentation of CR, up to second course of induction chemotherapy

  6. Remission duration

    Measured: Time from CR documentation to either AML relapse, assessed up to 10 years

Timeline

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

  1. First posted25 Jun 2012 (estimated)
  2. Study start16 Sep 2011
  3. Primary completion11 Feb 2016
  4. Study completion1 Feb 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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
178 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01627041
Sponsor's protocol ID
NCI-2012-01959
Other IDs
NCI-2012-01959, 1106011736, CDR0000712322, 1106011736, 8854, N01CM00070, N01CM62204
Status last verified
Apr 2026
First submitted
21 Jun 2012
Last updated
27 Apr 2026
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cytarabine, Daunorubicin Hydrochloride and Decitabine in people with Acute Myeloid Leukemia and Adult Acute Basophilic Leukemia, run by National Cancer Institute (NCI) at 9 sites 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 19 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 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites 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?

Complete remission rate (CR1) (time frame: After 1 course of decitabine-primed induction chemotherapy). 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 NCT01627041.

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 27 Apr 2026.

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