Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Can a 'Priming' drug boost chemo for tough leukemia?

NCT ID NCT01627041

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tests whether adding the drug decitabine to standard chemotherapy improves remission rates in adults with acute myeloid leukemia (AML) who have less favorable genetic risk. Decitabine is given before chemo to try to make cancer cells more sensitive. About 178 participants are enrolled, and the main goal is to see how many achieve complete remission.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
decitabine
What this could lead to
If successful, this could lead to a more effective chemotherapy regimen for acute myeloid leukemia, potentially improving remission rates.
What could go wrong
This is a mid-stage trial with 178 participants, so results may not apply to all patients. Adding decitabine could also increase side effects without improving outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

178 people

The number who actually took part.

Started

Sep 2011

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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) * 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 Exclusion Criteria: * 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 * 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)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Acute myeloid leukemia are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Case Western Reserve University

    Cleveland, Ohio, 44106, United States

  • Lafayette Family Cancer Center-EMMC

    Brewer, Maine, 04412, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467, United States

  • Montefiore Medical Center-Weiler Hospital

    The Bronx, New York, 10461, United States

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

    New York, New York, 10032, United States

  • NYP/Weill Cornell Medical Center

    New York, New York, 10065, United States

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210, United States

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.