Prephase Treatment With Prednisone +/- Vitamin D Supplementation Followed by Immunochemotherapy

Recruiting Phase 3 Interventional Study
Diffuse Large B-Cell Lymphoma Elderly Patients
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
65 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
430 (estimated)
Sponsor
Fondazione Italiana Linfomi - ETS · Other
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About This Trial
This is an open-label, multicenter, randomized phase III trial. The study plans to randomize patients with a 1 to 1 ratio to Arm A (Standard arm) or Arm B (Experimental arm). All patients of both arms will receive a prephase with oral prednisone before 6 cycles Q21 of immunochemotherapy with R-CHOP or R-miniCHOP at standard doses; patients in the Experimental arm (Arm B) will receive also a preph…
Trial Locations
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Eligibility Criteria
Inclusion criteria 1. Histologically documented diagnosis of Diffuse Large B-cell Lymphoma or Follicular grade IIIb lymphoma, as defined in the 2017 edition of the World Health Organization (WHO) classification. 2. Age ≥ 65 years 3. Comprehensive Geriatric Assessment performed at baseline, before s…
Contacts

Lorenza Randi, Dott.ssa

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lrandi@filinf.it

CONTACT

Francesco Merli, Dott.

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startup@filinf.it

CONTACT