31
Participants
Start Date
October 17, 2024
Primary Completion Date
October 31, 2029
Study Completion Date
October 31, 2029
Daratumumab plus chemotherapy according to the national treatment program
"Daratumumab is a human IgG1қ monoclonal antibody that binds with high affinity to a unique epitope on CD38, a transmembrane glycoprotein which is expressed in several hematological malignancies including multiple myeloma (MM) and ALL. Daratumumab induces lysis of CD38-expressing tumor cells by several mechanisms. Intravenous daratumumab has been approved first as a single agent and then in combinations in the MM setting and in AL amyloidosis.~The activity of daratumumab in ALL is being explored in the DELPHINUS trial, in which the drug was combined with chemotherapy in pediatric and young adult patients with relapsed/refractory T-cell ALL or lymphoblastic lymphoma (LL).~In the present trial, daratumumab will be administered to adult Very high risk T-lineage ALL weekly in induction and early consolidation (C1-C2), and the first day of each of the following intensive cycles up to C8."
RECRUITING
Ematologia AOU Careggi, Florence
RECRUITING
Ematologia P.O. Vito Fazzi - Lecce, Lecce
RECRUITING
Ematologia AOU Policlinico Umberto I, Roma
Gruppo Italiano Malattie EMatologiche dell'Adulto
OTHER