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Clinical Trials/EUCTR2016-003703-62-IT
EUCTR2016-003703-62-IT
Active, not recruiting
Phase 1

A phase II study of metronomic chemotherapy in elderly non-fit patients (>65 years) with aggressive B-Cell lymphomas. - FIL_DEVEC

FONDAZIONE ITALIANA LINFOMI ONLUS0 sites60 target enrollmentOctober 1, 2021
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ConditionsB-Cell lymphomasMedDRA version: 21.0Level: LLTClassification code 10012855Term: Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation)System Organ Class: 100000004864Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
DrugsPREDNISONE DOC GENERICI - 25 MG COMPRESSE 10 COMPRESSE IN BLISTER PVC-PVDC/ALUNAVELBINE - 30 MG CAPSULE MOLLI 1 CAPSULAENDOXAN BAXTER - 50 MG COMPRESSE RIVESTITE 50 COMPRESSEMABTHERA - 2 FIALE 100 MG 10 MLVEPESID - 50 MG CAPSULE MOLLI 20 CAPSULE

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
B-Cell lymphomas
Sponsor
FONDAZIONE ITALIANA LINFOMI ONLUS
Enrollment
60
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 1, 2021
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
FONDAZIONE ITALIANA LINFOMI ONLUS

Eligibility Criteria

Inclusion Criteria

  • •Histologically confirmed diagnosis of aggressive Non\-Hodgkin lymphomas (NHLs)\* including:
  • •\- Diffuse large B\-Cell lymphoma (DLBCL);
  • •\- Large B Cell Lymphomas;
  • •\- Grade IIIb follicular lymphoma;
  • •\- Burkitt lymphoma (Swerdlow SH et al, 2008\);
  • •\- High grade B\-cell lymphomas (Swerdlow SH, et al. 2016\);
  • •\- B\-Cell unclassifiable lymphomas with features intermediate between DLBCL and BL (Campo E et al, 2011\) or between DLBCL and Hodgkin’s lymphoma (HL).
  • •\* only for patients at disease onset or R/R with initial diagnosis of T\-NHL.
  • •Age \>65 years.
  • •Unfit or frail patients (the latest defined, for the purpose of this study, as those who have a maximum of 1 frail factor) according to the multidimensional geriatric evaluation model of the elderly platform of the FIL, who relapsed/progressed after one or maximum two previous lines of treatment or

Exclusion Criteria

  • •Patients who received more than two previous chemotherapy lines.
  • •Stage I, who may be treated with a short course of chemotherapy and radiotherapy.
  • •Patients with CNS involvement
  • •Relapsed/refractory patients with fit profile.
  • •Fit, unfit, and frail patients at disease onset.
  • •Patients with a high fragility functional status, defined, for the purpose of this study, as with \> 1 CIRS grade 3 or 1 CIRS grade 3 and \>8 CIRS grade 2\.
  • •Super\-Frail patients with more than 2 frail factors.
  • •Patient with Eastern Cooperative Oncology Group (ECOG) performance status \>2
  • •Malabsorption syndrome or other diseases that affect the ability to swallow oral therapy.
  • •Concomitant malignancy requiring treatment (except non\-melanoma skin cancers and in situ carcinoma of the uterine cervix).

Outcomes

Primary Outcomes

Not specified

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