Daratumumab in VHR T-ALL Treated According to the ALL National Treatment Program

PHASE2RecruitingINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

October 17, 2024

Primary Completion Date

October 31, 2029

Study Completion Date

October 31, 2029

Conditions
T-Lymphocytic Leukemia, Acute
Interventions
DRUG

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."

Trial Locations (3)

Unknown

RECRUITING

Ematologia AOU Careggi, Florence

RECRUITING

Ematologia P.O. Vito Fazzi - Lecce, Lecce

RECRUITING

Ematologia AOU Policlinico Umberto I, Roma

All Listed Sponsors
lead

Gruppo Italiano Malattie EMatologiche dell'Adulto

OTHER