| 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) |
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