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

Sponsor
Fondazione Italiana Linfomi - ETS
Study ID
NCT03161054
Phase
PHASE2
Status
Completed

Conditions

  • Aggressive Non-Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Prednisone — DRUG
    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).
  • Vinorelbine — DRUG
    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).
  • Etoposide — DRUG
    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
  • Cyclophosphamide — DRUG
    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).
  • Rituximab — DRUG
    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.

Study Details

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

Key Dates

Start date
Sep 12, 2017
Status verified
Dec 2021
Primary completion
Apr 22, 2020
Completion
Jun 21, 2021

Study Design

Enrollment
21 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: One arm for all patient
    Induction phase: Eligible Pts will receive 6 cycles (every 28 days) of the DEVEC combination: DE: Prednisone, V: Vinorelbine, E: Etoposide, C: Cyclophosphamide and R:Rituximab ; R will be administered 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 R will not repeat it during the metronomic therapy. Super-frail patients will not receive etoposide during cycles 1 and 2. Maintenance Phase: Pts in CR, CRu and PR at the end of the induction phase, will continue treatment with maintenance therapy including Vinorelbine, Cyclophosphamide, and Prednisone oral combination to be repeated every 28 days for up to 6 cycles. Post Maintenance Phase: Pts in CR/CRu at the EOT may, at discretion of the local investigator, continue maintenance with only Vinorelbine and Prednisone for up to further 12 months, progression or inacceptable toxicity at the same doses of maintenance

Primary Outcome Measure

Complete Remission Rate (CRR) [ Time Frame: 30 months ]

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