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Активно (без набиране) Фаза 1/2 NCT02677922

A Study to Assess the Safety and Efficacy of Two Combinations of Isocitrate Dehydrogenase (IDH) Mutant Targeted Therapies Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) Harboring IDH Mutations Who Are Not Candidates to Receive Intensive Induction Chemotherapy

Фаза 1/2 – комбинирано ранно изпитване
Заболявания: Leukemia, Myeloid, Acute

Спонсор: Celgene

Налично на: БГ
Обобщение
The purpose of this study are 1. to determine the recommended combination dose of AG-120 and AG-221 separately when administered with azacitidine and, 2. to investigate the safety, tolerability, and efficacy of the combinations of AG-120 with azacitidine and AG-221 with azacitidine versus with azacitidine alone in participants with acute myeloid leukemia (AML) with the isocitrate dehydrogenase (IDH) enzyme isoforms 1 or 2 mutations, respectively.
Кой може да участва
Inclusion Criteria: * Newly diagnosed, primary (ie, de novo) or secondary (progression of Myelodysplastic syndrome \[MDS\] or myeloproliferative neoplasms \[MPN\], or therapy-related) acute myeloid leukemia (AML) according to the WHO classification with ≥ 20% leukemic blasts in the bone marrow * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 * Agree to serial bone marrow aspirate/biopsies Exclusion Criteria: * Suspected or proven to have acute promyelocytic leukemia based on morphology, immunophenotype, molecular assay, or karyotype * AML secondary to chronic myelogenous leukemia (CML) * Received a targeted agent against an isocitrate dehydrogenase 1 (IDH1) or isocitrate dehydrogenase 2 (IDH2) mutation * Has or is suspected of having central nervous system (CNS) leukemia. Evaluation of cerebrospinal fluid is only required if CNS involvement by leukemia is suspected during screening Other protocol defined inclusion/exclusion criteria apply
Места на провеждане 13
Австралия (1)
Local Institution - 178
Adelaide , South Australia
Белгия (1)
Local Institution - UNK-121
Yvoir
Канада (1)
Local Institution - 125
Toronto , Ontario
Франция (1)
Local Institution - 205
Lille
Германия (1)
Local Institution - 227
Berlin
Италия (1)
Local Institution - 253
Bologna, Emilia-Romagna
Нидерландия (1)
Local Institution - 277
Utrecht
Португалия (1)
Local Institution - 327
Lisbon
Южна Корея (1)
Local Institution - 351
Seoul
Испания (1)
Local Institution - 379
Barcelona
Швеция (1)
Local Institution - UNK-52
Gothenburg
Великобритания (1)
Local Institution - 429
Birmingham
САЩ (1)
Local Institution - 105
Duarte , California
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 1/2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
03.06.2016
Крайна дата
30.09.2026
Регистрационен номер
NCT02677922
Източник
anzctr
Запитване за медицински туризъм

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