Study Comparing Standard Chemotherapy with CPX-351 for Adults with Newly Diagnosed Acute Myeloid Leukemia (AML) and Intermediate or Adverse Genetics

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What is this study about?

This clinical trial is focused on studying a type of blood cancer called Acute Myeloid Leukemia (AML). The study is specifically looking at adults who have been newly diagnosed with AML and have certain genetic characteristics that may affect their response to treatment. The trial will compare two different treatment approaches. One group of patients will receive standard intensive chemotherapy, while the other group will receive a treatment called CPX-351, which is a combination of two drugs, cytarabine and daunorubicin, delivered in a special form called liposomal. This form helps the drugs stay in the body longer and may improve their effectiveness.

The purpose of the study is to evaluate how well CPX-351 works compared to the standard chemotherapy in terms of overall survival, which means how long patients live after starting treatment. The study will involve patients receiving their assigned treatment and being monitored over time to see how they respond. Some patients may receive a placebo, which is a substance with no active medication, to help compare the effects of the treatments more accurately.

Participants in the study will receive their treatment through an intravenous infusion, which means the medication is given directly into a vein. The study will last for several months, with regular check-ups to monitor the patients’ health and response to the treatment. The goal is to find out if CPX-351 can improve survival rates for patients with AML compared to the standard treatment options currently available.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, health status, and genetic assessment.

Informed consent is required, ensuring understanding of the study’s purpose and procedures.

2 randomization

Participants are randomly assigned to one of two groups: standard intensive chemotherapy or intensive chemotherapy with CPX-351.

3 treatment phase

For those receiving standard intensive chemotherapy, the treatment includes cytarabine and daunorubicin, administered intravenously as a solution for infusion.

Participants in the CPX-351 group receive a liposomal formulation of cytarabine and daunorubicin, also administered intravenously.

The specific dosage and frequency are determined by the study protocol and medical team.

4 monitoring and follow-up

Regular monitoring of health status and response to treatment is conducted throughout the study.

Follow-up visits are scheduled to assess overall survival and any side effects experienced during the treatment.

5 end of study participation

Upon completion of the treatment phase, participants undergo final assessments to evaluate the impact of the treatment on their condition.

The study aims to determine the effectiveness of CPX-351 compared to standard chemotherapy in improving overall survival.

Who Can Join the Study?

  • Patients must have been newly diagnosed with AML (a type of blood cancer) and have specific genetic risks as defined by medical guidelines.
  • Female patients who can have children must agree not to get pregnant while on the study treatment and for 27 weeks after the last dose.
  • Women who can have children must either not have sexual intercourse or use a highly effective birth control method, like an IUD (a device placed in the uterus), along with another method like hormonal pills or the male partner using a condom with spermicide, during the study and for 27 weeks after.
  • Men must use a condom with spermicide during any sexual contact with women who can have children, even if they have had a vasectomy, and agree not to father a child during the study and for 6 months after the last dose. Their female partners must also use a highly effective birth control method.
  • Patients must be able to understand and willing to sign a consent form agreeing to participate in the study.
  • Patients must be 18 years or older, with no upper age limit.
  • Patients must be considered suitable for intensive chemotherapy treatment.
  • Patients must have an ECOG performance status of 2 or less, which is a measure of their ability to perform daily activities.
  • Patients must have a genetic assessment done in a specific laboratory.
  • Patients must have adequate kidney function, shown by certain levels of serum creatinine or creatinine clearance.
  • Patients must have adequate liver function, shown by certain levels of bilirubin, AST, ALT, and ALP, unless these levels are due to specific conditions approved by the study investigators.
  • Patients must not have had prior chemotherapy for acute leukemia, except for a specific medication called hydroxyurea for up to 14 days during diagnosis to control high white blood cell counts. Previous treatment for a related condition with certain agents is allowed.
  • Women who can have children must not be pregnant or nursing and must have a negative pregnancy test before starting the study.

Who Cannot Join the Study?

  • Patients who do not have newly diagnosed AML. AML stands for Acute Myeloid Leukemia, which is a type of blood cancer.
  • Patients who do not have intermediate- or adverse-risk genetics according to the 2017 ELN criteria. ELN stands for European LeukemiaNet, which provides guidelines for classifying the risk level of leukemia.
  • Patients who do not have AML with myelodysplasia-related changes (AML-MRC). Myelodysplasia refers to a group of disorders caused by poorly formed or dysfunctional blood cells.
  • Patients who do not have therapy-related AML. This type of AML occurs as a result of previous cancer treatments.
  • Patients who do not meet the World Health Organization (WHO) classification for the types of AML included in the study.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Other Sites

Site Name City Country Status
Helios Universitaetsklinikum Wuppertal Wuppertal Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Klinikum Esslingen GmbH Esslingen Am Neckar Germany
Otto Von Guericke Universitaet Magdeburg Magdeburg Germany
Kliniken Suedostbayern AG Traunstein Germany
Ortenau Klinikum Offenburg Germany
Axyczaaez Kklufuwu Hgwtdjm Gyvc Hamburg Germany
Ulckpmkmozwhvmwwfzbmk Tqygtwixd Aej Tuebingen Germany
Ccztwgs Uzpjpljralplaqolegfb Bunysw Ktv Berlin Germany
Ububsduighwqfhtmhjyit Depajojkpbb Auj Duesseldorf Germany
Sqdlauieoeaf Hkfbxqunq Gkhg Heilbronn Germany
Mnlngwy Umysozzvdh Ol Ghzm Graz Austria
Hosnysj Klgmmzdhbdd Dmt Wgoeic Gyjjursxwoonatvjsza Vienna Austria
Jpxplcmfgzwnzvvopsvbbdikgl Grsdlpr Giessen Germany
Mguylch Ctaaap &ghjhkq Ujomgriwrr Oh Fjtsnqov Freiburg Im Breisgau Germany
Kmzeeppx dal Thpcwugyscd Uolzdbtbgywu Mnbxtzcy (ggz Kgjxcevoe Munich Germany
Unyzptexhj Mrupdrc Cbgwrx Hdmzapmkyszoewwly Hamburg Germany
Oxhoekvgwmtata Luwg Gbja Linz Austria
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Umvyxxpxbpankafiqszid Sesqnujywzvppueavn Azl Kiel Germany
Kkhkeany Ouhxekaaw Apw Oldenburg In Holstein Germany
Pgzzaooxardrr Oelhkkbzk Oldenburg In Holstein Germany
Mdadygrk Npniqmoekkscnen giekt Flensburg Germany
Aspqlaqdnfsxltfyfwkmmvv gbvye Bochum Germany
Tetak Kkjkgkgf Gyth Innsbruck Austria
Kxyvjqjy Lwkuk Gosd Detmold Germany
Uikmskdxdtxkzhjabtatd Kkbcnmppdlwuovcnfljleni Bwqbzh Guvz Bochum Germany
Miprxr Hytolzyw Hrudr Umajouxcqswelcduyncy dyo Reqcxvrcaheotpnh Bfkrli Herne Germany
Kjmsvlqvoyfvaft Passau Germany
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Ujdbuopiircwyjedubsmd Rwysawmvjb Atk Regensburg Germany
Kzkbstve Dpo Lezwbjazfswwbiva Sebwpvohn gesjb Stuttgart Germany
Kewzgkze Affvduojwxoffnkisjavd geesi Aschaffenburg Germany
Kbpaxrxj Ekico Sxvu Egmdkalogjqef Ksaafisvscn Eyddnahqjcgo gqsxm Essen Germany
Vsjpgyqugsjq Kexbgxdscjrxggmsllosipbxymewesdx mom Feldkirch Austria
Wzocrrksrhurlsmtqn Ghes Kaiserslautern Germany
Skrwqboeotfwbqgj Kklpnccn Vjrvkllaiponayqvofaxbs Ggnz Villingen-Schwenningen Germany
Kfzdd Sob Pqpmlj Gsxx Dortmund Germany
Sfllfmlgijex Kmhuclqy Besraxufgxsu gjwtx Brunswick Germany
Hrovgv Kklbgfbk Bul Shmikd Gljn Bad Saarow Germany
Smwuomyknxgd Kyhzkqnu Khjojqsgz gwxyk Karlsruhe Germany
Bhnbobilmco Bnzzwoj Tqcmj gqjcq Trier Germany
Virfcclb Nvjtchfd fpls Gntqwrwbpf Guzk Berlin Germany
Kfunlpam Mabvotevcj dop Bmieivjidobrydz gyowc Trier Germany
Kenbnuxk Rgvayh Hmrmrsxr Gycy Hanover Germany
Kuhzptgt dkz Shgmz Lrafacvuvxdn av Rkkgt gicus Ludwigshafen Am Rhein Germany
Asqfryina Kggtrs Sy Gywupt Hamburg Germany
Dqukazczgxbundsnp Shmhxzkea Deoyzjwmmjacwdnzxcuteo ucd Ptfseiodbxqyy gmktn Stuttgart Germany
Essgzfgoyhzvv Krousxwlwgz Hlcw gkzhi Hamm Germany
Kxnlulef Damikmhkz Gght Darmstadt Germany
Minoaiaruo Kxlovumk Gkpi Luedenscheid Germany
Mfvhegpxuhzkkaobvmgn Amt Minden Germany
Gqfbfzkqvb Ndwk gmjxc Kwmkqjhjzcjcs Btsspp Bremen Germany
Kkqnswxb Ospazs ggqyaarkqgdvay kjreoyull Aubxokn dym ogeajjbuoxkse Rwngrd Mutlangen Germany
Sjbl Cpkhv Gmkhvemzuz Salzburg Austria
Mbfefltlov Kfgshidc Srw Etbqtbkww Skvuibisz Saarlouis Germany
Kegctydr Huampwagxknwp Gneb Meschede Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
01.10.2019
Germany Germany
Not recruiting
01.10.2019

Trial locations

Investigated Drugs:

CPX-351 is a medication being studied for its potential to improve survival in adults with newly diagnosed acute myeloid leukemia (AML) who have intermediate or adverse genetic profiles. It is a type of chemotherapy that combines two drugs, designed to target and kill cancer cells more effectively.

Standard Intensive Chemotherapy refers to the usual treatment regimen for AML, which involves using strong drugs to kill cancer cells. This therapy is typically used to try to achieve remission in patients by reducing the number of cancer cells in the body.

Investigated Diseases:

Acute Myeloid Leukemia (AML) – Acute Myeloid Leukemia is a type of cancer that affects the blood and bone marrow, characterized by the rapid growth of abnormal white blood cells. These abnormal cells accumulate in the bone marrow, interfering with the production of normal blood cells. AML can lead to symptoms such as fatigue, frequent infections, and easy bruising or bleeding. The disease progresses quickly and requires prompt medical attention. AML with myelodysplasia-related changes (AML-MRC) and therapy-related AML are specific subtypes that have distinct genetic and clinical features. These subtypes are classified based on genetic abnormalities and previous exposure to chemotherapy or radiation.

Trial ID:
2023-503670-21-00
Protocol code:
AMLSG 30-18
NCT ID:
NCT03897127
Trial Phase:
Therapeutic confirmatory (Phase III)

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