Deutsches Leukämie-Studienregister
Studie: FORMA 2102

Kurzübersicht
Öffentlicher Titel Phase I/II Studie zu Olutasidenib bei myeloischen Krebserkrankungen mit IDH1-Mutation
Wissenschaftl. Titel A Phase 1/2, Multicenter, Open-label Study of FT-2102 as a Single Agent and in Combination with Azacitidine or Cytarabine in Patients with Acute Myeloid Leukemia or Myelodysplastic Syndrome with an IDH1 Mutation
Kurztitel FORMA 2102
Studiennummer KN/ELN LN_NN_2019_694
Studiengruppe NN
Studienart multizentrisch, einarmig, offen
Studienphase Phase II
Erkrankung Myelodysplastisches Syndrom (MDS) - Intermediär II und Hochrisiko
Akute myeloische Leukämie (AML) - AML alle außer FAB M3
Leukämiestadium de novo/non-treated
Molekularer Marker IDH1
Einschlusskriterien
  • Pathologically proven acute myeloid leukemia (AML) (except acute promyelocytic leukemia [APL] with the t(15;17) translocation) or intermediate, high-risk, or very high risk Myelodysplastic Syndrome (MDS) as defined by the World Health Organization (WHO) criteria or Revised International Prognostic Scoring System (IPSS-R) which is relapsed or refractory (R/R) to standard therapy and/or for which standard therapy is contraindicated or which has not adequately responded to standard therapy
  • Patients must have documented IDH1-R132 gene-mutated disease as evaluated by the site
  • Good performance status
  • Good kidney and liver function
Ausschlusskriterien
  • Patients with symptomatic central nervous system (CNS) metastases or other tumor location (such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture, etc.) necessitating an urgent therapeutic intervention, palliative care, surgery or radiation therapy
  • Congestive heart failure (New York Heart Association Class III or IV) or unstable angina pectoris. Previous history of myocardial infarction within 1 year prior to study entry, uncontrolled hypertension or uncontrolled arrhythmias
  • Pulmonary disease (e.g. COPD, asthma, etc) that is not controlled (moderate to severe symptoms) with current medication
  • Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
Alter >= 18 Jahre
Status Aktiv
Beginn der Rekrutierung 22.11.2019
Kurzprotokoll Kurzprotokoll
Sponsoren Forma Therapeutics, Inc.
Registrierung in anderen Studienregistern ClinicalTrials.gov NCT02719574
European Clinical Trials Database - EUDRACT 2017-001051-32
erstellt 18.11.2020 Zenawit Krüger
geändert 23.12.2020 Student Studienregister
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