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

Gå till den engelska sidan

New drug combo shows promise for Tough-to-Treat leukemia in younger patients

NCT ID NCT04269213

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 09, 2026 · Updated 4 times

Summary

This study tests a chemotherapy drug called CPX-351 in people under 60 with secondary acute myeloid leukemia (AML), a type of leukemia that develops after other blood disorders or cancer treatments. The goal is to see how well the drug can make the cancer disappear or improve blood counts. About 21 participants will receive the treatment, and researchers will track how long any benefits last.

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

21 people

The number who actually took part.

Started

Jul 2021

Finished

Apr 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 59 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: * Newly diagnosed: * Therapy-related acute myeloid leukemia (AML) * AML with antecedent myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) * AML with MDS-related changes (as per World Health Organization \[WHO\]) * Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2 * Plasma creatinine =\< 1.5 x upper limit of normal (ULN) * Total bilirubin \< 2.0 mg/dL * Serum alanine aminotransferase and aspartate aminotransferase \< 3 x ULN * Left ventricular ejection fraction by echocardiogram or multiple-gated acquisition \>= 50% * Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. 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 * Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to enrollment and commit to two forms of birth control * Men must use a latex condom during any sexual contact with women of childbearing potential * Willing to adhere to protocol specific requirements * Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure Exclusion Criteria: * Prior treatment of AML * Known clinically active central nervous system (CNS) leukemia * Core-binding factor leukemia * Acute promyelocytic leukemia * Uncontrolled other malignancy * Prior anthracycline exposure \> 368 mg/m\^2 of daunorubicin or equivalent * Cardiovascular disease resulting in heart failure (New York Heart Association class III or IV), unstable angina (angina symptoms at rest), or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months * Hypersensitivity to cytarabine, daunorubicin, or liposomal drugs * Known active HIV infection * Known history of active hepatitis B or C infection * Pre-existing liver disease (e.g. cirrhosis, chronic hepatitis B or C, nonalcoholic steatohepatitis, sclerosing cholangitis) * Evidence of ongoing, uncontrolled systemic infection * Pregnant or breastfeeding women * Subject with concurrent severe and/or uncontrolled medical or psychiatric conditions that in the opinion of the investigator may impair the participation in the study or the evaluation of safety and/or efficacy * History of Wilson disease or other copper-handling disorders * Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Acute myeloid leukemia arising from previous myelodysplastic syndrome 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

  • Allegheny Health Network Cancer Institute - West Penn Hospital

    Pittsburgh, Pennsylvania, 15224, United States

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263, United States

  • SUNY Upstate Medical Center

    Syracuse, New York, 13210, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

More trials for these conditions

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