Metronomic Chemotherapy in Elderly Non-fit Patients With Aggressive B-Cell Lymphomas

PHASE2CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

September 12, 2017

Primary Completion Date

April 22, 2020

Study Completion Date

June 21, 2021

Conditions
Aggressive Non-Hodgkin Lymphoma
Interventions
DRUG

Prednisone

"Induction Phase: Prednisone (Deltacortene) 25 mg /day will be orally administered from day 1 to day 28 only in cycle 1 From cycle 2 to 6 reduce to three times a week (after breakfast).~Maintenance Phase: Prednisone 25 mg/day will be orally administered twice a week continuously (after breakfast).~Post Maintenance Phase: Prednisone 25 mg/day will be orally administered twice a week continuously (after breakfast)."

DRUG

Vinorelbine

"Induction Phase: Vinorelbine 30 mg/day will be orally administered three times a week, 3 weeks on and 1 week off (after breakfast).~Maintenance Phase: Vinorelbine 30 mg/day will be orally administered three times a week, 3 weeks on and 1 week off (after breakfast).~Post Maintenance Phase: vinorelbine 30 mg/day will be orally administered three times a week, 3 weeks on and 1 week off (after breakfast)."

DRUG

Etoposide

Induction Phase Etoposide: 50 mg/day will be orally administered from day 1 to day 14 (before lunch); Superfrail patients only from cycle 3, 50 mg/day, from day 1 to day 7

DRUG

Cyclophosphamide

"Induction Phase: Cyclophosphamide 50 mg/day will be orally administered from day 1 to day 21 (after dinner).~Maintenance Phase: 50 mg/day will be orally administered from day 1 to day 14 (after dinner)."

DRUG

Rituximab

Induction Phase: Rituximab: 375 mg/m2 will be administered by IV infusion up to four infusions on days 8, 15, 22, 29, only in patients suitable for infusion treatment and relapsed after \>6 months from last R-chemotherapy. Refractory patients who received at least 5 doses of Rituximab will not repeat it during the metronomic therapy.

Trial Locations (10)

Unknown

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

Ospedale di Castelfranco Veneto - Ematologia, Castelfranco Veneto

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) - Ematologia, Meldola

Ospedale Guglielmo da Saliceto - U.O.Ematologia, Piacenza

Ospedale delle Croci - Ematologia, Ravenna

Azienda Ospedaliera Arcispedale Santa Maria Nuova - IRCCS c/o CORE (II piano) - Ematologia, Reggio Emilia

AO Sant'Andrea - Ematologia, Roma

Nuovo Ospedale Civile di Sassuolo - Day Hospital Oncologico, Sassuolo

AOU Senese - U.O.C. Ematologia, Siena

A.O.U. Citta della Salute e della Scienza di Torino - Ematologia Universitaria, Torino

All Listed Sponsors
lead

Fondazione Italiana Linfomi - ETS

OTHER

NCT03161054 - Metronomic Chemotherapy in Elderly Non-fit Patients With Aggressive B-Cell Lymphomas | Biotech Hunter | Biotech Hunter