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Primary comparison of liposomal anthracycline based treatment versus conventional care strategies before allogeneic stem cell transplantation in patients with higher risk MDS and oligoblastic AML

NCT ID NCT04061239

NEW Sponsor: GWT-TUD GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Last updated Sep 10, 2026

Summary

To compare the event-free survival at 2 years of CPX-351 vs. conventional care regimens before allogeneic blood cell transplantation as first line treatment in patients with higher risk MDS and oligoblastic AML.

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

150 people

The number who actually took part.

Started

Aug 2019

Finished

Aug 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 75 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: * Male and female adult patients, 18-75 years of age * Diagnosis of high risk MDS including oligoblastic non-proliferative (WBC \<13 Gpt/l) AML up to 29% of bone marrow blasts * Availability of BM blast count from central morphology * Bone marrow blasts ≥ 5% * IPSS score intermediate or high * alloHCT intended within the next 6 months * ECOG performance status of 0 or 1 * Signed informed consent * Laboratory values fulfilling the following: * Serum creatinine \< 2.0 mg/dL * Serum total bilirubin \< 2.0 mg/dL * Serum alanine aminotransferase or aspartate aminotransferase \< 3 times the ULN * Cardiac ejection fraction (LVEF) ≥ 50% by echocardiography * Contraception: * Female subjects of childbearing potential† must agree to use a medically acceptable method of contraception for at least 2 months prior to the first dose of CPX-351 and consent of female patients to use a medically acceptable method of contraception throughout the entire study period and for 6 months following the last dose of CPX-351. Medically acceptable methods of contraception that may be used by the patient include abstinence, diaphragm and spermicide, intrauterine device (IUD), condom and vaginal spermicide, hormonal contraceptives (patients must be stable on hormonal contraceptives for at least the prior 3 months), surgical sterilization, or post-menopausal (≥2 years of amenorrhea). Medically acceptable methods of contraception that may be used by the male partner of a female patient are condom and spermicide or vasectomy (\>6 months prior to Day-1) and are to be used throughout the entire study period and for 6 months following the last dose of CPX-351. * Male patients must be willing to refrain from sperm donation for 6 months following the last dose of CPX-351 and must use adequate contraception throughout the entire study period and for 6 months following the last dose of CPX-351. * Combined oral contraceptive pills are not recommended. It is recommended that during the study two medically accepted methods of contraception (e.g. as hormonal contraceptive methods along with a condom) apply. Exclusion Criteria: * Patients with history of myeloproliferative neoplasms (MPN) (defined as a history of essential thrombocytosis or * polycythemia vera, or idiopathic myelofibrosis prior to the diagnosis of AML) or combined MDS/MPN are not eligible. * WHO-2016 defined AML entities: AML with t(15;17), PML-RARA; AML with t(8;21), RUNX1-RUNX1T1, AML with inv(16)/t(16;16), CBFβ-MYH11; AML with biallelic CEBPA mutation; AML with mutated FLT3 or NPM1. * Clinical evidence of active CNS leukemia. * Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse within one year. * Any major surgery or radiation therapy within four weeks prior screening. * Patients with prior treatment of either CPX-351, hypomethylating agents, cytarabine or intensive chemotherapy for high-risk MDS or AML. * Patients with prior cumulative anthracycline exposure of greater than 368 mg/m2 daunorubicin (or equivalent). * Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent obtaining informed consent. * Patients with myocardial impairment of any cause (e.g. cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease, and congestive heart failure) resulting in heart failure by New York Heart Association Criteria (NYHA Class III or IV staging). * Active or uncontrolled infection. Patients with an infection receiving treatment (antibiotic, antifungal or antiviral treatment) may be entered into the study but must be afebrile and hemodynamically stable for ≥72 hrs. * Current evidence of invasive fungal infection (blood or tissue culture); patients with recent fungal infection must have a subsequent negative cultures to be eligible; known HIV (new testing not required) or evidence of active hepatitis B or C infection (with rising transaminase values). * Hypersensitivity to cytarabine, daunorubicin or liposomal products. * History of Wilson's disease or other copper-metabolism disorder. * Female patients who are pregnant or lactating.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia myelodysplastic syndrome

As listed by the trial registrant

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

AML MDS

Contacts and locations

Locations

  • Charité - Universitätsmedizin Berlin

    Berlin, 12200, Germany

  • Gemeinschaftsklinikum Mittelrhein gGmbH

    Koblenz, 56068, Germany

  • Helios Klinikum Berlin-Buch GmbH

    Berlin, 13125, Germany

  • Klinikum Chemnitz-gGmbH

    Chemnitz, 09113, Germany

  • Klinikum Frankfurt (Oder) GmbH

    Frankfurt, 15236, Germany

  • Klinikum Nürnberg

    Nuremberg, 90419, Germany

  • Klinikum rechts der Isar der TU München

    München, 81675, Germany

  • Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • Ordensklinikum Linz Elisabethinen GmbH

    Linz, 4020, Austria

  • Robert-Bosch-Krankenhaus Stuttgart

    Stuttgart, 70376, Germany

  • Universitätsklinikum Aachen

    Aachen, 52074, Germany

  • Universitätsklinikum Augsburg

    Augsburg, 86156, Germany

  • Universitätsklinikum Bonn (UKB)

    Bonn, 53127, Germany

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, 01307, Germany

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225, Germany

  • Universitätsklinikum Essen

    Essen, 45122, Germany

  • Universitätsklinikum Frankfurt

    Frankfurt, 60590, Germany

  • Universitätsklinikum Halle

    Halle, 06120, Germany

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120, Germany

  • Universitätsklinikum Jena

    Jena, 07740, Germany

  • Universitätsklinikum Köln

    Cologne, 50937, Germany

  • Universitätsklinikum Leipzig AöR

    Leipzig, Germany

  • Universitätsklinikum Münster

    Münster, 48149, Germany

  • Universitätsklinikum Tübingen

    Tübingen, 72076, Germany

  • Universitätsklinikum Ulm

    Ulm, 89081, Germany

  • Universitätsmedizin Mannheim

    Mannheim, 68167, Germany

  • Universitätsmedizin Rostock

    Rostock, 18055, Germany

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