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ACTIVE NOT RECRUITING
NCT02223208
PHASE1/PHASE2

Ro Plus CHOEP as First Line Treatment Before HSCT in Young Patients With Nodal Peripheral T-cell Lymphomas

Sponsor: Fondazione Italiana Linfomi - ETS

View on ClinicalTrials.gov

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

Interventions

DRUG

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)

DRUG

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