Klinische Studie
A mulitcentre, randomized trial in adults with de novo Philadelphia- Chromosome positive acute lymphoblastic leukemia to assess the efficacy of ponatinib versus imatinib in combination with low-intensity chemotherapy to compare subsequent allogenic stem cell transplantation (SCT) versus TKI in combination with blinatumomab and chemotherapy in optimal responders and to evaluate Blinatumomab before SCT in suboptimal responders (GMALL-EVOLVE)(GMALL-Evolve)Random. Studie, BCR-ABL pos., akute lymphoblastische Leukämie, Ponat. vs. Imat. in Kombination mit Chemotherapie, verglichen mit darauffolgender SZT vs. TKI in Komb. mit Blina + Chemo/ Blina vor SZT
Krankheitsentität(en)
Blut (Leukämie), Lymphknoten, Knochenmark
StudientypInterventionsstudiePhase II
StudientypInterventionsstudiePhase II
Wesentliche EinschlusskriterienDe novo Ph+ALL; age >= 18 -65 yrs; ECOG <= 2 normal QTcF interval <= 450 ms for males and <= 470 ms for female
Wesentliche AusschlusskriterienHistory of malignancy other than ALL diagnosed within 5 yrs. prior to start of protocol-specified therapy with defined exceptions; any other concurrent disease interfering with study treatment; pregnant and nursing women; contraindications against the use of Ima, Pona, chemotherapy or Blina
Statusrekrutierend
Ansprechpartner & KontaktUniversitätsklinikum RegensburgInnere Medizin IIIStudienzentrale0941 9441557studienzentrale.med3(at)ukr.de