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.
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…
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