Spots Global Cancer Trial Database for A Study of Cusatuzumab Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy
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Trial Identification
Brief Title: A Study of Cusatuzumab Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy
Official Title: A Phase 2 Study of Cusatuzumab Plus Azacitidine in Patients With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy
Study ID: NCT04023526
Conditions
Study Description
Brief Summary: The purpose of this study is to determine the efficacy of cusatuzumab in combination with azacitidine in participants with previously untreated acute myeloid leukemia (AML) who are not eligible for intensive chemotherapy.
Detailed Description: AML is a heterogeneous disease characterized by uncontrolled clonal expansion of hematopoietic progenitor cells. As the most common form of acute leukemia, AML accounts for the largest number of annual deaths from leukemia. Over 95 percent (%) of AML blasts harvested from newly diagnosed AML participants expressed Cluster of Differentiation (CD) 70 on the cell surface. Cusatuzumab (JNJ-74494550) is a humanized monoclonal antibody of camelid origin, binding with tight affinity to human CD70. Cusatuzumab has been modified to induce enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) for therapeutic use in participants with cancer. Azacitidine is a pyrimidine nucleoside analogue of cytidine with antineoplastic activity and is indicated for the treatment of adult participants with AML or intermediate 2 and high-risk myelodysplastic syndrome (MDS) with greater than 20% marrow blasts who are not eligible for hematopoietic stem cell transplantation. This study will evaluate 2 doses of cusatuzumab in combination with standard dose azacitidine in participants with AML who are not candidates for intensive chemotherapy (Part 1). Part 1 data will be reviewed by a Data Review Committee to select a preferred dose of cusatuzumab. The study will include a Screening Phase (28 days prior to randomization), a Treatment Phase, and a Follow-up Phase. The study includes evaluations like vital signs, electrocardiogram, spirometry test, serum chemistry and hematology tests.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
St Vincents Hospital Sydney, Darlinghurst, , Australia
St Vincents Hospital Melbourne, Fitzroy, , Australia
The Alfred Hospital, Melbourne, , Australia
Royal Perth Hospital, Perth, , Australia
Westmead Hospital, Westmead, , Australia
Universidade Estadual De Campinas, Campinas, , Brazil
Hospital das Clinicas de Porto Alegre, Porto Alegre, , Brazil
CHU d'Angers, Angers, , France
CHU Grenoble, Grenoble cedex 9, , France
Institut Paoli Calmettes, Marseille Cedex 9, , France
Centre Hospitalier Universitaire (CHU) de Bordeaux Hopital HautLeveque Centre Francois Magendie, Pessac, , France
CHU Lyon Sud, Pierre - Bénite Cedex, , France
Institut Universitaire du Cancer Toulouse Oncopole, Toulouse Cedex 9, , France
CHRU Tours Hôpital Bretonneau, Tours, , France
Rambam Medical Center, Haifa, , Israel
Hadassah Medical Center, Jerusalem, , Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel
Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna, Bologna, , Italy
Azienda Ospedaliera Spedali Civili di Brescia, Brescia, , Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, , Italy
Istituto Europeo di Oncologia, Milano, , Italy
ASST Grande Ospedale Metropolitano Niguarda, Milano, , Italy
Division of Hematology, Cardarelli Hospital, Napoli, , Italy
Azienda Sanitaria Universitaria Integrata di Udine, Udine, , Italy
Chelyabinck Regional Clinical Hospital, Chelyabinsk, , Russian Federation
Ekaterinburg City Clinical Hospital # 7, Ekaterinburg, , Russian Federation
S.P. Botkin Moscow City Clinical Hospital, Moscow, , Russian Federation
City Clinical Hospital # 40, Moscow, , Russian Federation
Nizhniy Novgorod Region Clinical Hospital, Nizhniy Novgorod, , Russian Federation
Ryazan Regional Clinical Hospital, Ryazan, , Russian Federation
City clinical hospital #15, Saint Petersburg, , Russian Federation
Samara Region Clinical Hospital, Samara, , Russian Federation
Oncologic Dispensary No.2, Sochi, , Russian Federation
St.-Petersburg Clinical Research Institute of Hematology and Transfusiology, St. Petersburg, , Russian Federation
Komi Republic Oncology dispensary, Syktyvkar, , Russian Federation
Hosp. de La Santa Creu I Sant Pau, Barcelona, , Spain
Inst. Cat. Doncologia-H Duran I Reynals, Barcelona, , Spain
Hosp. Univ. Vall D Hebron, Barcelona, , Spain
Hosp. Reina Sofia, Cordoba, , Spain
Hosp. Univ. Ramon Y Cajal, Madrid, , Spain
Hosp. Univ. 12 de Octubre, Madrid, , Spain
Hosp. Univ. Son Espases, Palma, , Spain
Hosp. Quiron Madrid Pozuelo, Pozuelo De Alarcon, Madrid, , Spain
Hosp. Clinico Univ. de Salamanca, Salamanca, , Spain
Hosp. Univ. I Politecni La Fe, Valencia, , Spain
Kantonsspital Aarau, Aarau, , Switzerland
INSELSPITAL, Universitätsspital Bern, Bern, , Switzerland
Hopitaux Universitaires de Geneve, Geneve, , Switzerland
UniversitaetsSpital Zuerich, Zürich, , Switzerland
Gulhane Egitim ve Arastirma Hastanesi, Ankara, , Turkey
Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital, Ankara, , Turkey
Ankara University Medical Faculty Hematology Department - Hematology, Ankara, , Turkey
Ondokuz Mayis Universitesi Tip Fakultesi, Atakum, , Turkey
Istanbul Egitim ve Arastirma Hastanesi, Istanbul, , Turkey
Dokuz Eylul Universitesi Tip Fakultesi, Izmir, , Turkey
Karadeniz Teknik University Medical Faculty, Trabzon, , Turkey
Contact Details
Name: Clayton Smith, MD
Affiliation: OncoVerity, Inc.
Role: STUDY_DIRECTOR
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