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3644 : Non Pegilated Liposomal Doxorubicin (TLC-D99; Myocet ) Can Be Safely and Effectively Used As Part of the R-COMP Regimen in Patients with Diffuse Large B-Cell Lymphoma Who Show Contraindications to Anthracyclines Due to Concomitant Moderate/Severe Heart Disease. Results of the HEART01 Phase II trial by the Fondazione Italiana Linfomi (NCT01009970)

Researchers

Presenter

  • Michele Spina

Principal Investigators

  • Stefano Luminari

  • Andrés José María Ferreri

  • Francesco Zaja

  • Monica Balzarotti

  • Flavia Salvi

  • Moira Micheletti

  • Gerardo Musuraca

  • Elda Viel

  • Stefano Volpetti

  • Emanuela Anna Pesce

  • Marta Bruno Ventre

  • Massimo Federico

Medical Centers

  • Hematology, Humanitas Cancer Center, Rozzano, Rozzano, Italy

  • Surgery Unit, National Cancer Institute, Bari, Italy

  • Unit of Lymphoid Malignancies, Department of Hemato-Oncology, San Raffaele Scientific Institute, Milan, Italy

  • S.C. Ematologia, A.O. SS. Antonio e Biagio e C. Arrigo, Alessandria, Italy

  • Div. of Medical Oncology A, Centro Di Riferimento Oncologico, Aviano, Italy

  • Unit of Lymphoid Malignancies, Departement of Onco-Hematological Medicine, San Raffaele Hospital, Milan, Italy

  • Department of Diagnostic, Clinical and Public Health Medicine, University of Modena and Reggio Emilia, Modena, Italy

  • Department of Hematology, Spedali Civili di Brescia, Brescia, Italy

  • Clinica Ematologica, DISM, AOUD S. M. Misericordia, Udine, Italy

Locations

  • Italy

Companies

  • N/A

Study Components

Therapeutic Area

  • Oncology (ONC)

Disease

  • Diffuse large B-cell lymphoma

  • Left ventricular hypertrophy

  • Arrhythmia

  • Deep vein thrombosis

  • Pulmonary arterial hypertension

  • Myocardial infarction

  • Renal insufficiency

  • Venous thrombosis

  • Thrombocytopenia

  • B cell lymphomas

  • Cardiac arrest

  • Hypertension

  • Neutropenia

  • Lymphomas

  • Anemia

  • Solid malignancies

Biomarkers

  • N/A

Drug/Treatment

  • Cyclophosphamide

  • Cyclophosphamide Injection

  • Vincristine

  • Doxorubicin

  • Prednisone

  • Rituximab

  • Doxorubicin Hydrochloride

Outcome

  • N/A


Study Design

  • pharmacokinetics

Phase

  • NA

Study Id's

  • N/A

Sponsors

  • N/A

Result

  • Interim