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

NCT03161054 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2021-12-20

No results posted yet for this study

Summary

This is a phase II study of metronomic chemotherapy in elderly non-fit patients (\>65 years) with aggressive B-Cell lymphomas

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.

Sponsors & Collaborators

  • Fondazione Italiana Linfomi - ETS

    lead OTHER

Principal Investigators

  • Francesco Merli, MD · AUSL - IRCCS Arcispedale Santa Maria Nuova viale Risorgimento 80 42123, Reggio Emilia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-12
Primary Completion
2020-04-22
Completion
2021-06-21

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03161054 on ClinicalTrials.gov