Prephase treatment with prednisone +/- Vitamin D supplementation followed by immunochemotherapy in Elderly patients with Diffuse Large B-Cell Lymphoma (DLBCL). A randomized, open label, phase III study by Fondazione Italiana Linfomi.

Conditions

Elderly patients with Diffuse Large B-Cell Lymphoma (DLBCL)

Brief summary

Progression-Free Survival (PFS).

Detailed description

Overall Survival (OS)., Event Free Survival (EFS)., Response rate (ORR, CRR; Cheson 2014)., Early death rate (EDR): all deaths recorded within 90 days from the date of diagnosis., AEs rate (CTCAE current version)., Rate of ECOG changes after prephase., Rate of 25(OH)VitD correction (VitD supplementation arm): number of patients with 25(OH)VitD levels above or equal 20ng/ml at day 1 of cycle 2., Rate of patients who maintain 25(OH)VitD levels in the normal range at EOI., PROs endpoints include: time-to-deterioration in EORTC QLQ-C30 physical functioning and fatigue and FACT-Lym-LymS; proportion of patients in each arm achieving meaningful improvement in EORTC-QLQ-C30 physical functioning and fatigue, and FACT-Lym-LymS; and a comparison of EORTC-QLQ-C30 treatment-related symptoms between the two treatment arms.

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGCOLECALCIFEROL

DRUGPREDNISONE

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-Free Survival (PFS).	—

Secondary

Measure	Time frame
Overall Survival (OS)., Event Free Survival (EFS)., Response rate (ORR, CRR; Cheson 2014)., Early death rate (EDR): all deaths recorded within 90 days from the date of diagnosis., AEs rate (CTCAE current version)., Rate of ECOG changes after prephase., Rate of 25(OH)VitD correction (VitD supplementation arm): number of patients with 25(OH)VitD levels above or equal 20ng/ml at day 1 of cycle 2., Rate of patients who maintain 25(OH)VitD levels in the normal range at EOI., PROs endpoints include: time-to-deterioration in EORTC QLQ-C30 physical functioning and fatigue and FACT-Lym-LymS; proportion of patients in each arm achieving meaningful improvement in EORTC-QLQ-C30 physical functioning and fatigue, and FACT-Lym-LymS; and a comparison of EORTC-QLQ-C30 treatment-related symptoms between the two treatment arms.	—

Measure

Time frame

Overall Survival (OS)., Event Free Survival (EFS)., Response rate (ORR, CRR; Cheson 2014)., Early death rate (EDR): all deaths recorded within 90 days from the date of diagnosis., AEs rate (CTCAE current version)., Rate of ECOG changes after prephase., Rate of 25(OH)VitD correction (VitD supplementation arm): number of patients with 25(OH)VitD levels above or equal 20ng/ml at day 1 of cycle 2., Rate of patients who maintain 25(OH)VitD levels in the normal range at EOI., PROs endpoints include: time-to-deterioration in EORTC QLQ-C30 physical functioning and fatigue and FACT-Lym-LymS; proportion of patients in each arm achieving meaningful improvement in EORTC-QLQ-C30 physical functioning and fatigue, and FACT-Lym-LymS; and a comparison of EORTC-QLQ-C30 treatment-related symptoms between the two treatment arms.

—

Countries

Italy

Outcome results

None listed