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Clinical Trials in Spain / NCT04023526
Active, not recruiting Phase 2

A Study of Cusatuzumab Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy

NCT04023526 · tracked via the Priya Life Science Spain tracker
Phase
Phase 2
Started
2019-07-29
Last updated
2025-08-20

Condition(s) studied

Leukemia, Myeloid, Acute

Investigational drug(s) / intervention(s)

Azacitidine →Cusatuzumab →

Azacitidine: Azacitidine SC or IV will be administered at a standard dose of 75 mg/m\^2 on days 1-7 of each cycle.

Cusatuzumab: Cusatuzumab IV will be administered as 10 mg/kg or 20 mg/kg on days 3 and 17 of each cycle.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Acute myeloid leukemia (AML) according to World Health Organisation (WHO) 2016 criteria and fulfilling all of the following criteria that defines those who are "not candidates for intensive chemotherapy": 1. greater than or equal to (\>=)75 years of age or 2. less than (\<) 75 years of age with at least one of the following comorbidities: Eastern Cooperative Oncology Group (ECOG) Performance Status of 2; Severe cardiac comorbidity defined as congestive heart failure or ejection fraction less than or equal to (\<=) 50 percent (%); Severe pulmonary comorbidity defined as documented pulmonary disease with lung diffusing capacity for carbon monoxide (DLCO) \<=65% of expected, or forced expiratory volume in 1 second (FEV1) \<=65% of expected or dyspnea at rest requiring oxygen; Moderate hepatic impairment defined according to NCI organ dysfunction classification criteria (total bilirubin \>=1.5 up to 3 times upper limit of normal \[ULN\]); Creatinine clearance \<45 milliliter per minute per 1.73 meter square (mL/ min/1.73 m\^2); Comorbidity that, in the Investigator's opinion, makes the participant unsuitable for intensive chemotherapy and must be documented and approved by the Sponsor before randomization * De novo or secondary AML * Previously untreated AML (except: emergency leukapheresis, hydroxyurea, and/or 1 dose of cytarabine \[example: 1-2 gram per meter square {g/m\^2}\] during the Screening Phase to control hyperleukocytosis. These treatments must be discontinued \>=24 hours prior to start of study drug). Empiric all trans retinoic acid (ATRA) treatment for presumed acute promyelocytic leukemia (APL) is permitted but APL must be ruled out and ATRA must be discontinued \>=24 hours prior to the start of study drug * Not eligible for an allogeneic hematopoietic stem cell transplantation * ECOG Performance Status score of 0, 1 or 2 Exclusion Criteria: * Acute promyelocytic leukemia * Leukemic involvement or clinical symptoms of leukemic involvement of the central nervous system * Use of immune suppressive agents for the past 4 weeks before the first administration of cusatuzumab on Cycle 1 Day 3. For regular use of systemic corticosteroids, participants may only be included if free of systemic corticosteroids for a minimum of 5 days before the first administration of cusatuzumab. Treatment of adrenal insufficiency with physiologic replacement doses of corticosteroids are allowed * Prior treatment with a hypomethylating agent for treatment of AML or myelodysplastic syndrome (MDS) * Active malignancies (that is, progressing or requiring treatment in the last 24 months) other than the disease being treated under the study * Any active systemic infection * Known allergies, hypersensitivity, or intolerance to cusatuzumab or azacitidine or its excipients (that is, mannitol, an excipient of azacitidine)

Primary outcome measure(s)

Trial sites (56)

FacilityCityRegionStatus
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 France
Institut Paoli Calmettes Marseille France
Centre Hospitalier Universitaire (CHU) de Bordeaux Hopital HautLeveque Centre Francois Magendie Pessac France
CHU Lyon Sud Pierre-Bénite France
Institut Universitaire du Cancer Toulouse Oncopole Toulouse 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 Milan Italy
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Division of Hematology, Cardarelli Hospital Naples Italy
Azienda Sanitaria Universitaria Integrata di Udine Udine Italy
Chelyabinck Regional Clinical Hospital Chelyabinsk Russia
S.P. Botkin Moscow City Clinical Hospital Moscow Russia
City Clinical Hospital # 40 Moscow Russia
Nizhniy Novgorod Region Clinical Hospital Nizhny Novgorod Russia
Ryazan Regional Clinical Hospital Ryazan Russia
St.-Petersburg Clinical Research Institute of Hematology and Transfusiology Saint Petersburg Russia
City clinical hospital #15 Saint Petersburg Russia
Samara Region Clinical Hospital Samara Russia
Oncologic Dispensary No.2 Sochi Russia
Komi Republic Oncology dispensary Syktyvkar Russia
Ekaterinburg City Clinical Hospital # 7 Yekaterinburg Russia
Hosp. Quiron Madrid Pozuelo Pozuelo de Alarcón Madrid
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 Córdoba Spain

+ 16 more sites — see the full list on the official registry below.

More OncoVerity, Inc. trials in Spain

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04023526 on ClinicalTrials.gov ↗ ← All trials in Spain