NCT01805557 - Phase II Randomized Study With R-DHAP +/- Bortezomib as Induction Therapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL) Patients Eligible to Transplantation. BR-DHAP Versus R-DHAP. | Biotech Hunter

Enrollment

108

Participants

Timeline

Start Date

February 4, 2013

Primary Completion Date

March 12, 2019

Study Completion Date

November 20, 2020

Conditions

Diffuse Large B-cell Lymphoma RefractoryDiffuse Large B-cell Lymphoma Recurrent

Interventions

DRUG

R-DHAP

"* Rituximab 375 mg/sqm iv day 0 or 1~* Cisplatin 100 mg/sqm iv day 1 in 6-hours infusion~* Cytarabine 2000 mg/sqm in 3-hours infusion iv day 2 and day 3~* Dexamethasone 40 mg day 1-4~* Pegfilgrastim 6 mg sc monodose 24 hours after the end of chemotherapy or G-CSF from day 5 till stem cell harvest during mobilization's course (II o III cycle R-DHAP)~* Rituximab 375 mg/sqm iv 24 hours before apheresis as purging in vivo during second courses of therapy"

DRUG

BR-DHAP

"* Rituximab 375 mg/sqm iv day 0 or 1~* Bortezomib SC 1.5 mg/sqm day 1, day 4~* Cisplatin 100 mg/sqm iv day 1 in 6-hours infusion~* Cytarabine 2000 mg/sqm in 3-hours infusion iv day 2 and day 3~* Dexamethasone 40 mg day 1-4~* Pegfilgrastim 6 mg sc monodose 24 hours after the end of chemotherapy or G-CSF from day 5 till stem cell harvest during mobilization's course (II o III cycle R-DHAP)~* Rituximab 375 mg/sqm iv 24 hours before apheresis as purging in vivo during second courses of therapy Chemotherapy R-DHAP and BR-DHAP will be repeated every 28 days."

Trial Locations (24)

10126

AOU Citta della Salute e della Scienza di Torino - Ematologia Universitaria, Torino

AOU Citta della Salute e della Scienza di Torino-SC Ematologia, Torino

15121

A.O. SS. Antonio e Biagio e C. Arrigo, Alessandria

16132

Ematologia 1 Ospedale S. Martino, Genova

20089

Clinica Humanitas, Rozzano

20133

SC Ematologia - Trapianto di midollo osseo Fond. IRCCS Istituto Nazionale Tumori, Milan

20162

ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia, Milan

25123

ASST Spedali Civili di Brescia - Ematologia, Brescia

28100

SCDU Ematologia - Università del Piemonte Orientale, Novara

29121

Ospedale Civile Guglielmo da Saliceto, Piacenza

33081

CRO Aviano, Aviano

33100

Azienda Ospedaliero - Universitaria di Udine, Udine

35128

Ospedale S. Antonio, Padua

42123

AO Arcispedale S.Maria Nuova Ematologia, Reggio Emilia

43100

U.O. Complessa di Ematologia Ospedale di Parma, Parma

47014

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-Ematologia, Meldola

47923

Osp. degli Infermi Divisione di Oncologia, Rimini

48121

Osp. S. Maria delle Croci, Ravenna

60100

Clinica di ematologia AOU Umberto I Ospedali Riuniti, Ancona

89124

Grande Ospedale Metropolitano Bianchi Melacrino Morelli - Ematologia, Reggio Calabria

Unknown

ASST Valle Olona, Gallarate

09121

Ospedale Businco - SC Ematologia e CTMO, Cagliari

00189

A.O. Universitaria S. Andrea, Roma

05100

SC Oncoematologia con autotrapianto AO Santa Maria, Terni