Clinical Trials Using Liposomal Cytarabine-Daunorubicin CPX-351

Clinical trials are research studies that involve people. The clinical trials on this list are studying Liposomal Cytarabine-Daunorubicin CPX-351. All trials on the list are supported by NCI.

NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.

Trials 1-20 of 20
  • CPX-351 and Glasdegib for the Treatment of Therapy-Related Acute Myeloid Leukemia

    This phase II trial studies how well CPX-351 and glasdegib work for the treatment of therapy-related acute myeloid leukemia. CPX-351 is a combination of 2 chemotherapies, daunorubicin and cytarabine, and may work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Glasdegib is a smoothened inhibitor designed to reduce or stop the growth of leukemic cells. Giving CPX-351 and glasdegib together may slow the growth and spread of cancer in patients with therapy-related acute myeloid leukemia.
    Location: 5 locations

  • CPX-351 and Gemtuzumab Ozogamicin in Treating Patients with Relapsed Acute Myeloid Leukemia

    This phase Ib trial studies the best dose of gemtuzumab ozogamicin when given together with CPX-351 in treating patients with acute myeloid leukemia that has come back after it was previously in remission. CPX-351 is a type of chemotherapy. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Gemtuzumab ozogamicin is a monoclonal antibody, called gemtuzumab, linked to chemotherapy called calicheamicin. Gemtuzumab attaches to CD33 positive cancer cells in a targeted way and delivers ozogamicin to kill them. Giving CPX-351 and gemtuzumab ozogamicin may work better in treating patients with acute myeloid leukemia, compared to giving only one of these therapies alone.
    Location: 5 locations

  • A Trial of CPX-351 Lower Intensity Therapy (LIT) Plus Venetoclax as First Line Treatment for Subjects With AML

    Study CPX351-103 is an open-label, multicenter, phase 1b, safety and PK study to determine the MTD of the combination of CPX 351 and venetoclax when administered to subjects with newly diagnosed AML who are unfit for intensive chemotherapy (ICT). This study will comprise 2 phases: a Dose Escalation Phase and an Expansion Phase, in which all subjects will receive a combination of CPX-351 and venetoclax.
    Location: 5 locations

  • Liposome-Encapsulated Daunorubicin-Cytarabine in Treating Participants with Higher Risk Myelodysplastic Syndrome Who Are Transplant Eligible

    This phase I trial studies the side effects of liposome-encapsulated daunorubicin-cytarabine in treating participants with higher risk myelodysplastic syndrome who are transplant eligible. Drugs used in chemotherapy, such as liposome-encapsulated daunorubicin-cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
    Location: 3 locations

  • A Trial to Evaluate the Potential Impact of Renal Impairment on the Pharmacokinetics and Safety of CPX-351

    This study evaluates the pharmacokinetics and safety of CPX-351 in patients with moderate or severe renal impairment.
    Location: 5 locations

  • A Phase 1b Master Trial to Investigate CPX-351 in Subjects With Previously Untreated Acute Myeloid Leukemia

    JZP025-101 is an open-label, multicenter, multi-arm, nonrandomized phase 1b master trial to determine the recommended phase 2 dose (RP2D) of CPX-351 when administered in combination with various targeted agents in previously untreated subjects with Acute Myeloid Leukemia (AML) who are fit to receive intensive chemotherapy (ICT). Subjects will be assigned to treatment arms based on results of AML mutation testing.
    Location: 4 locations

  • CPX-351 for the Treatment of Secondary Acute Myeloid Leukemia in Patients Younger than 60 Years Old

    This phase II trial studies how well liposome-encapsulated daunorubicin-cytarabine (CPX-351) works in treating patients with secondary acute myeloid leukemia who are younger than 60 years old. Drugs used in chemotherapy, such as CPX-351, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
    Location: Roswell Park Cancer Institute, Buffalo, New York

  • CPX-351 or CLAG-M Regimen for the Treatment of Acute Myeloid Leukemia or Other High-Grade Myeloid Neoplasms in Medically Less-Fit Patients

    This phase II trial studies how well CPX-351 or the CLAG-M regimen (consisting of the drugs cladribine, cytarabine, G-CSF, and mitoxantrone) works in treating medically less-fit patients with acute myeloid leukemia or other high-grade myeloid neoplasms. Drugs used in chemotherapy, such as CPX-351, cladribine, cytarabine, G-CSF, and mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving CPX-351 or the CLAG-M regimen at doses typically used for medically-fit patients with acute myeloid leukemia may work better than reduced doses of CPX-351 in treating medically less-fit patients with acute myeloid leukemia or other high-grade myeloid neoplasms.
    Location: Fred Hutch / University of Washington Cancer Consortium, Seattle, Washington

  • Vyxeos in Treating Patients with Intermediate and High-Risk Acute Myeloid Leukemia Who Have Failed an Initial Cycle of Standard Cytarabine and Daunorubicin Chemotherapy

    This phase II trial studies the side effects and how well Vyxeos works in treating patients with intermediate and high-risk acute myeloid leukemia who have failed an initial cycle of standard cytarabine and daunorubicin chemotherapy. Vyxeos is a combination of both chemotherapy drugs cytarabine and daunorubicin contained in a liposome. Drugs used in chemotherapy, such as cytarabine and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cytarabine and daunorubicin given together in liposomes may have fewer side effects and work better than cytarabine and daunorubicin given alone in patients with acute myeloid leukemia.
    Location: Ohio State University Comprehensive Cancer Center, Columbus, Ohio

  • CPX-351 in Treating Patients with Myelodysplastic Syndromes after Hypomethylating Agent Failure

    This phase II trial studies how well CPX-351 works in treating patients with myelodysplastic syndromes, who have failed previous treatment with azacitidine or decitabine (hypomethylating agents). CPX-351 is an investigational (experimental) drug for the treatment of myelodysplastic syndrome that works by delivering two chemotherapy medications (daunorubicin and cytarabine) together which are then concentrated into the bone marrow (the part of the body that makes blood cells). Drugs used in chemotherapy, such as daunorubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
    Location: Case Comprehensive Cancer Center, Cleveland, Ohio

  • CPX-351 in Treating Patients with Relapsed or Refractory High Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia

    This phase I trial studies best dose and side effects of liposome-encapsulated daunorubicin-cytarabine (CPX-351) and how well it works in treating patients with high risk myelodysplastic syndrome or chronic myelomonocytic leukemia that has come back or has not responded to treatment. Drugs used in chemotherapy, such as liposome-encapsulated daunorubicin-cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Ruxolitinib and Daunorubicin (CPX-351) in Treating Patients with Secondary Acute Myeloid Leukemia Transformed from Myeloproliferative Neoplasms

    This phase I / II trial studies the best dose of ruxolitinib when given together with daunorubicin (CPX-351) and to see how well they work in treating patients with secondary acute myeloid leukemia transformed from myeloproliferative neoplasms. Ruxolitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. CPX-351 is a mixture of 2 chemotherapy drugs (daunorubicin and cytarabine) given for leukemia in small fat-based particles (liposomes) to improve the drug getting into cancer cells. Giving ruxolitinib and CPX-351 may work better in treating patients with secondary acute myeloid leukemia compared to CPX-351 alone.
    Location: OHSU Knight Cancer Institute, Portland, Oregon

  • CPX-351 and Palbociclib in Treating Patients with Recurrent or Refractory Acute Myeloid Leukemia

    This phase I / II trial studies the side effects and best dose of palbociclib when given together with CPX-351 and to see how well they work in treating patients with acute myeloid leukemia that has come back (recurrent) or does not respond to treatment (refractory). Drugs used in chemotherapy, such as CPX-351, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Palbociclib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. The purpose of this study is to test the safety and efficacy of the combination of palbociclib plus CPX-351 in patients with acute myeloid leukemia.
    Location: Case Comprehensive Cancer Center, Cleveland, Ohio

  • CPX-351 plus Enasidenib for Relapsed AML

    This trial evaluates how well CPX-351 and enasidenib work in treating patients with acute myeloid leukemia characterized by IHD2 mutation. Drugs used in chemotherapy, such as CPX-351, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Enasidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving CPX-351 and enasidenib may work better in treating patients with acute myeloid leukemia, compared to giving only one of these therapies alone.
    Location: 4 locations

  • Liposome-encapsulated Daunorubicin-Cytarabine and Gemtuzumab Ozogamicin in Treating Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) or High Risk Myelodysplastic Syndrome

    This phase II trial studies the side effects and how well liposome-encapsulated daunorubicin-cytarabine and gemtuzumab ozogamicin work in treating patients with acute myeloid leukemia that has come back (relapsed) or that does not respond to treatment (refractory) or high risk myelodysplastic syndrome. Drugs used in chemotherapy, such as liposome-encapsulated daunorubicin-cytarabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Gemtuzumab ozogamicin is a monoclonal antibody, called gemtuzumab, linked to a toxic agent called calicheamicin. Gemtuzumab ozogamicin attached to CD33 positive cancer cells in a targeted way and delivers calicheamicin to kill them. Giving liposome-encapsulated daunorubicin-cytarabine and gemtuzumab ozogamicin together may be an effective treatment for relapsed or refractory acute myeloid leukemia or high risk myelodysplastic syndrome.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Liposome-encapsulated Daunorubicin-Cytarabine and Venetoclax in Treating Participants with Relapsed, Refractory or Untreated Acute Myeloid Leukemia

    This phase II trial studies how well liposome-encapsulated daunorubicin-cytarabine and venetoclax work in treating participants with acute myeloid leukemia that has come back (relapsed), does not respond to treatment (refractory), or has not been treated (untreated). Drugs used in chemotherapy, such as liposome-encapsulated daunorubicin-cytarabine and venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
    Location: M D Anderson Cancer Center, Houston, Texas

  • CPX-351 in Treating Patients with Acute Lymphoblastic Leukemia that has come back after prior therapy or does not respond to treatment

    This phase II trial studies how well CPX-351 works in treating patients with acute lymphoblastic leukemia that has come back or does not respond to treatment. CPX-351 is combination of two chemotherapy drugs called cytarabine and daunorubicin which are protected inside fat particles called liposomes to help prevent these drugs from being eliminated / destroyed by the body. Drugs used in chemotherapy, such as CPX-351, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
    Location: Moffitt Cancer Center, Tampa, Florida

  • Cytarabine, Idarubicin and Liposome-encapsulated Daunorubicin-Cytarabine, or Venetoclax, Azacitidine, and Decitabine in Treating Older Patients with Acute Myeloid Leukemia

    This phase II trial studies how well cytarabine and idarubicin or venetoclax, azacitidine and decitabine work in treating patients with acute myeloid leukemia. Drugs used in chemotherapy, such as cytarabine, idarubicin, liposome-encapsulated daunorubicin-cytarabine and venetoclax, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Azacitidine and decitabine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving patients cytarabine, idarubicin, liposome-encapsulated daunorubicin-cytarabine, venetoclax, azacitidine or decitabine may work better in treating patients with acute myeloid leukemia based on clinicogenetic risk stratification.
    Location: University of Nebraska Medical Center, Omaha, Nebraska

  • Liposomal Cytarabine and Daunorubicin (CPX-351) and Quizartinib for the Treatment of Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome

    This phase I / II trial studies the side effects and best dose of CPX-351 in combination with quizartinib for the treatment of acute myeloid leukemia and high risk myelodysplastic syndrome. CPX-351, composed of chemotherapy drugs daunorubicin and cytarabine, works in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Quizartinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The goal of this study is to learn if the combination of CPX-351 and quizartinib can help to control acute myeloid leukemia and myelodysplastic syndrome.
    Location: M D Anderson Cancer Center, Houston, Texas

  • A Study to Compare Standard Chemotherapy to Therapy with CPX-351 and / or Gilteritinib for Patients with Newly Diagnosed AML with or without FLT3 Mutations

    This phase III trial compares standard chemotherapy to therapy with CPX-351 and / or gilteritinib for patients with newly diagnosed acute myeloid leukemia with or without FLT3 mutations. Drugs used in chemotherapy, such as daunorubicin, cytarabine, and gemtuzumab ozogamicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. CPX-351 is made up of daunorubicin and cytarabine and is made in a way that makes the drugs stay in the bone marrow longer and could be less likely to cause heart problems than traditional anthracycline drugs, a common class of chemotherapy drug. Some acute myeloid leukemia patients have an abnormality in the structure of a gene called FLT3. Genes are pieces of DNA (molecules that carry instructions for development, functioning, growth and reproduction) inside each cell that tell the cell what to do and when to grow and divide. FLT3 plays an important role in the normal making of blood cells. This gene can have permanent changes that cause it to function abnormally by making cancer cells grow. Gilteritinib may block the abnormal function of the FLT3 gene that makes cancer cells grow. The overall goals of this study are, 1) to compare the effects, good and / or bad, of CPX-351 with daunorubicin and cytarabine on people with newly diagnosed AML to find out which is better, 2) to study the effects, good and / or bad, of adding gilteritinib to AML therapy for patients with high amounts of FLT3 / ITD or other FLT3 mutations and 3) to study changes in heart function during and after treatment for AML. Giving CPX-351 and / or gilteritinib with standard chemotherapy may work better in treating patients with acute myeloid leukemia compared to standard chemotherapy alone.
    Location: Location information is not yet available.