Clinical Research Directory
Browse clinical research sites, groups, and studies.
Ro Plus CHOEP as First Line Treatment Before HSCT in Young Patients With Nodal Peripheral T-cell Lymphomas
Sponsor: Fondazione Italiana Linfomi - ETS
Summary
This is a multicenter study that includes two phases: 1. A phase I study to define the maximum tolerated dose (MTD) of Romidepsin in addition to CHOEP-21 and to test the safety and feasibility of CHOEP-21 in combination with dose escalation of Romidepsin (8, 10, 12, 14 mg). The dose level defined as MTD of Romidepsin will be used for the subsequent phase II study. 2. A phase II study to evaluate the efficacy (response rate, progression free survival and overall survival) and safety of Ro-CHOEP-21 incorporated into a treatment strategy including SCT.
Official title: Romidepsin in Combination With CHOEP as First Line Treatment Before Hematopoietic Stem Cell Transplantation in Young Patients With Nodal Peripheral T-cell Lymphomas: a Phase I-II Study
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
89
Start Date
2014-09
Completion Date
2026-02
Last Updated
2025-12-02
Healthy Volunteers
No
Conditions
Interventions
Ro-CHOEP-21 (PHASE I)
Romidepsin (dose escalation) Starting dose: 12mg/ms iv day +1 and +8 Dose modification according to toxicity: * 14mg/ms day +1 and +8 * 10mg/ms day +1 and +8 * 8mg/ms day +1 and +8 CHOEP-21 * Doxorubicin 50 mg/ms iv day +1 or +2, * Vincristin 1.4 mg/ms (maximum 2.0 mg total dose) iv day+1 or +2 * Cyclophosphamide 750 mg/ms iv day +1 or +2 * Etoposide 100mg/ms iv from day +1 to +3 or from day +2 to +4 * Prednisone100 mg orally from days +1 to +5 or from days +2 to +6 PR or CR:Ro-CHOEP-21 for 3 additional cycles followed by stem cell mobilization and transplantation phase (CR --\> AUTO-SCT, PR --\> ALLO-SCT)
Ro-CHOEP-21 (PHASE II)
Ro-CHOEP-21 x 3 cycles * Romidepsin dose according to phase I iv day +1 and +8 * Doxorubicin 50 mg/ms iv day +1 or +2, * Vincristin 1.4 mg/ms (maximum 2.0 mg total dose) iv day+1 or +2, * Cyclophosphamide 750 mg/ms iv day +1 or +2 * Etoposide 100mg/ms iv from day +1 to +3 or from day +2 to +4 * Prednisone100 mg orally from days +1 to +5 or from days +2 to +6 PR or CR: Ro-CHOEP-21 for 3 additional cycles followed by stem cell mobilization and transplantation phase (CR --\> AUTO-SCT, PR --\> ALLO-SCT)
Locations (27)
Ospedale SS. Antonio e Biagio e Cesare Arrigo
Alessandria, AL, Italy
Policlinico S. Orsola Malpighi
Bologna, BO, Italy
Spedali Civili
Brescia, BS, Italy
Ospedale Businco
Cagliari, CA, Italy
Azienda Ospedaliera S.Croce e Carle
Cuneo, CN, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) - Sede di Meldola
Meldola, FC, Italy
IRCCS AOU San Martino - Clinica Ematologica
Genova, GE, Italy
IRCCS AOU San Martino - UO Ematologia 1
Genova, GE, Italy
Istituto Clinico Humanitas
Rozzano, Milano, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, MI, Italy
Fondazione IRCCS "Istituto Nazionale dei Tumori"
Milan, MI, Italy
Azienda Ospedaliera Ospedale Niguarda Ca' Granda
Milan, MI, Italy
AO Ospedali Riuniti Villa Sofia - Cervello (Presidio Cervello)
Palermo, PA, Italy
IRCCS Centro di Riferimento Oncologico (CRO)
Aviano, PN, Italy
AOU di Parma
Parma, PR, Italy
Fondazione IRCCS - Policlinico San Matteo
Pavia, PV, Italy
IRCCS Arcispedale "Santa Maria Nuova"
Reggio Emilia, RE, Italy
Ospedale degli Infermi
Rimini, RN, Italy
AO Città della Salute e della Scienza - Ematologia 1U
Torino, TO, Italy
AO Città della Salute e della Scienza - SC Ematologia
Torino, TO, Italy
AOU "Santa Maria della Misericordia"
Udine, UD, Italy
Ospedale Borgo Roma
Verona, VR, Italy
Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
Naples, Italy
Ospedale Maggiore della Carità - SCDU Ematologia
Novara, Italy
A.O. di Perugia - Santa Maria della Misericordia
Perugia, Italy
Ospedale G. Da Saliceto - AUSL di Piacenza
Piacenza, Italy
UO Ematologia Ospedale S.Maria delle Croci
Ravenna, Italy