Study to Evaluate Combined Treatment of Daratumumab, Bortezomib and Dexamethasone in PBL Patients.

PHASE2RecruitingINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

July 11, 2022

Primary Completion Date

January 1, 2026

Study Completion Date

January 1, 2026

Conditions
Plasmablastic Lymphoma
Interventions
DRUG

Daratumumab

"Induction phase planning one course (cycle 1) of daratumumab as single agent followed by 8 courses (cycles 2-9) of daratumumab in combination with bortezomib and dexamethasone (DVd regimen).~Patients achieving at least a SD after induction will be addressed to the maintenance phase, planning a maximum of 6 cycles (cycles 10-15) of daratumumab as single agent."

DRUG

Bortezomib

"Induction phase planning one course (cycle 1) of daratumumab as single agent followed by 8 courses (cycles 2-9) of daratumumab in combination with bortezomib and dexamethasone (DVd regimen).~Patients achieving at least a SD after induction will be addressed to the maintenance phase, planning a maximum of 6 cycles (cycles 10-15) of daratumumab as single agent."

DRUG

Dexamethasone

"Induction phase planning one course (cycle 1) of daratumumab as single agent followed by 8 courses (cycles 2-9) of daratumumab in combination with bortezomib and dexamethasone (DVd regimen).~Patients achieving at least a SD after induction will be addressed to the maintenance phase, planning a maximum of 6 cycles (cycles 10-15) of daratumumab as single agent."

Trial Locations (18)

10126

RECRUITING

A.O. Universitaria Citta' Della Salute E Della Scienza Di Torino, Torino

31100

RECRUITING

Struttura Complessa di Ematologia PO TREVISO, Treviso

35128

RECRUITING

U.O. Ematologia AO di Padova, Padua

37134

RECRUITING

AOU Integrata di Verona - U.O. Ematologia, Verona

50141

RECRUITING

Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia, Florence

60126

RECRUITING

A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona, Ancona

90127

NOT_YET_RECRUITING

A.O. Universitaria Policlinico Giaccone Di Palermo, Palermo

Unknown

RECRUITING

Aviano - IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuto-correlati, Aviano

RECRUITING

Milano - ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia, Miano

RECRUITING

Monza - ASST MONZA Ospedale S. Gerardo - Ematologia, Monza

ACTIVE_NOT_RECRUITING

Napoli - AORN - Azienda Ospedaliera dei Colli Monald - U.O.C. Oncologia, Napoli

NOT_YET_RECRUITING

Roma - IRCCS Spallanzani - Servizio di Ematologia in malattie infettive, Roma

RECRUITING

Roma - Ospedale S. Camillo - Ematologia, Roma

RECRUITING

A.O. Spedali Civili di Brescia - Ematologia, Brescia

RECRUITING

Istituto Scientifico San Raffaele, Unità Linfomi - Dipartimento Oncoematologia, Milan

NOT_YET_RECRUITING

Ematologia IRCCS Policlinico S. Matteo di Pavia, Pavia

RECRUITING

AO Arcispedale S.Maria Nuova Ematologia, Reggio Emilia

NOT_YET_RECRUITING

A.O. S. Maria di Terni - S.C. Oncoematologia, Terni

All Listed Sponsors
collaborator

Janssen-Cilag S.p.A.

INDUSTRY

lead

Fondazione Italiana Linfomi - ETS

OTHER