Deutsches Leukämie-Studienregister
Studie: DECLINE

Gesamtübersicht
Öffentlicher Titel Phase IIIb Studie zur Bestimmung der Konversionsrate von MMR zu MR >= 4 log bei CML
Wissenschaftl. Titel Imatinib 400 mg Daily vs Nilotinib 300 mg Twice Daily in Patients With Chronic Myeloid Leukemia in 1st Chronic Phase and Confirmed Major Molecular (MMR) Response Receiving Imatinib at a Dose of 400 mg Daily.
Kurztitel DECLINE
Studiengruppe NN
Studienart randomisiert, prospektiv, offen, zweiarmig
Erkrankung Chronische myeloische Leukämie (CML) - Chronische Phase
Molekularer Marker BCR-ABL
Alter >= 18 Jahre
Status Aktiv
Beginn der Rekrutierung 01.09.2014
Studienleiter/in von Bubnoff, Prof.Dr., Nikolas
Ansprechpartner

Principal Investigator
von Bubnoff, Prof.Dr., Nikolas
E-Mail: nikolas.bubnoff@uniklinik-freiburg.de

Kurzprotokoll Kurzprotokoll
Anmerkung Primary end point: Proportion of patients with confirmed conversion from MMR to MR4 after two years of study treatment. Confirmed conversion from MMR to MR4 is defined as either BCR-ABL/ABL ≤ 0.01% IS at 21 and 24 months or BCR-ABL/ABL ≤ 0.01% IS at 24 months and confirmation within six weeks. (Month 21 and 24) Secondary end points: • Cumulative incidence of MR4 and MR4.5 after one and two years of study treatment • Proportion of patients with MR4 lasting for at least one year, defined as BCR-ABL/ABL <= 0.01% IS in at least three out of four consecutive 3-monthly meas-urements with first and last measurement showing MR4 • Proportion of patients with MR4 lasting for at least two years, defined as BCR-ABL/ABL <= 0.01% IS in at least six out of eight consecutive 3-monthly meas-urements with first and last measurement showing MR4 • Proportion of patients with MR4.5 lasting for at least one year, defined as BCR-ABL/ABL <= 0.0032% IS in at least three out of four consecutive 3-monthly measurements with first and last measurement showing MR4,5 • Proportion of patients with MR4.5 lasting for at least two years, defined as BCR-ABL/ABL <= 0.0032% IS in at least six out of eight consecutive 3-monthly measurements with first and last measurement showing MR4,5 • Kinetics of BCR-ABL transcript levels over time • Proportion of patients with confirmed conversion from MMR to MR4 two years after cross-over from Imatinib to Nilotinib in patients failing the primary end-point in the Imatinib arm (patients failing to achieve confirmed MMR to MR4 conversion two years after randomization and continued treatment with Imatinib) • Analysis of baseline clinical data which are informative with respect to MMR to MR4 conversion • Application of a previously developed mathematical model to predict the pa-tient-specific probability of reaching MR4 under continuous Imatinib • To establish a mathematical model to predict molecular relapse probability af-ter treatment discontinuation (to be validated in DECLINEplus) • Analysis of changes in the health-related Quality of Life (EORTC-QLQ-C30, EORTC-QLQ-CML24) • Study drug compliance (patient diary)
erstellt 24.09.2014 Hanna Ebert
geändert 09.11.2015 Zenawit Krüger
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