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Active (not recruiting) Phase 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

Phase 1/2 – combined early trial
Conditions: Leukemia, Myeloid, Acute

Sponsor: Celgene

trial.available_in: БГ
Overview
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.
Who can participate
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
Locations 13
Australia (1)
Local Institution - 178
Adelaide , South Australia
Belgium (1)
Local Institution - UNK-121
Yvoir
Canada (1)
Local Institution - 125
Toronto , Ontario
France (1)
Local Institution - 205
Lille
Germany (1)
Local Institution - 227
Berlin
Italy (1)
Local Institution - 253
Bologna, Emilia-Romagna
Netherlands (1)
Local Institution - 277
Utrecht
Portugal (1)
Local Institution - 327
Lisbon
South Korea (1)
Local Institution - 351
Seoul
Spain (1)
Local Institution - 379
Barcelona
Sweden (1)
Local Institution - UNK-52
Gothenburg
United Kingdom (1)
Local Institution - 429
Birmingham
United States (1)
Local Institution - 105
Duarte , California
Technical details
Status
Active (not recruiting)
Phase
Phase 1/2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
03.06.2016
Completion date
30.09.2026
Registry ID
NCT02677922
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.