A Combination of Rituximab and CC-99282 as Front-line Therapy for Older Frail Patients With Diffuse Large B-cells Non-Hodgkin Lymphoma Evaluated With a Simplified Geriatric Assessment (sGA): a Phase II Study of the Fondazione Italiana Linfomi (FIL)

Status: Recruiting
Location: See all (19) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Prospective, multicenter, single arm, phase II study, to evaluate the efficacy of the combination rituximab-golcadomide as a chemo free approach in a population of older patients with new diagnosis of DLBCL, defined as frail according to a sGA evaluation and not candidate for the standard R-CHOP (or R-CHOP like) treatments.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 80
Healthy Volunteers: f
View:

• Able to provide written informed consent form approved by the National Ethics Committee (NEC) prior to the initiation of any screening or study- specific procedures and able to understand and to comply with the requirements of the study and the schedule of assessments.

• Histologically documented diagnosis of DLBCL as defined in the 5th edition of the World Health Organization (WHO) classification (2022)

• Previously untreated

• Frail patients defined as follows (Appendix A-D): Age ≥ 80 years: activity of daily living (ADL) \< 6 residual functions and/or Instrumental activity of daily living (IADL) \< 8 residual functions and/or cumulative illness rating scale (CIRS) \> 5 comorbidities of grade 2 and/or one or more comorbidities of grade 3-4

• Patient not eligible to anthracycline-based chemotherapy

• Ann Arbor Stage I - IV (Appendix E)

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 3 (Appendix F)

• At least one site of measurable nodal disease at baseline \[≥ 1.5 cm\] in the longest transverse diameter as determined by CT scan

• Adequate hematological counts defined as follows:

‣ WBC \> 2.5 x 109/L with ANC \> 1.0 x 109/L unless due to bone marrow involvement by lymphoma

⁃ Platelet count ≥ 75 x 109/L unless due to bone marrow involvement by lymphoma

⁃ Hemoglobin ≥ 10 g/dL unless anemia related to active lymphoma

⁃ Adequate renal function defined as creatinine clearance ≥ 30 mL/min (Appendix G). The same CrCl cutoff applies in case of documented renal involvement by lymphoma

⁃ Adequate hepatic function per local laboratory reference range, unless secondary to lymphoma, as follows:

∙ Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.0 x ULN

‣ Bilirubin ≤ 2 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin, i.e. mild and chronic hemolysis)

⁃ Subject must be able to adhere to the study visit schedule and other protocol requirements

⁃ Subject must be able to swallow capsules or tablets

⁃ Life expectancy ≥ 3 months

⁃ Male subjects must practice complete abstinence when this is in line with the usual lifestyle (periodic abstinence is not permitted) or agree to use specified contraceptive methods (barrier contraception: condom) during sexual contact with a female of childbearing potential while participating in the study, for at least 28 days following investigational product discontinuation, even if he has undergone a successful vasectomy. Furthermore, they do not have to donate sperm during the study and for at least 28 days after receiving the last dose of study drug. If applicable, male subjects must receive study specific Pregnancy Prevention Plan (PPP).

Locations
Other Locations
Italy
AOU SS. Antonio e Biagio e Cesare Arrigo di Alessandria - SCDU Ematologia
RECRUITING
Alessandria
AOU Ospedali Riuniti - Clinica di Ematologia
RECRUITING
Ancona
Azienda Ospedaliera S. Giuseppe Moscati - S.C. Ematologia e trapianto emopoietico
RECRUITING
Avellino
Ospedale IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuno-correlati
RECRUITING
Aviano
ASST Spedali Civili di Brescia - Ematologia
RECRUITING
Brescia
Azienda Ospedaliera Universitaria Careggi -Unità Funzionale di Ematologia
NOT_YET_RECRUITING
Florence
ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia
RECRUITING
Milan
Fondazione IRCCS San Gerardo dei Tintori -Ematologia
NOT_YET_RECRUITING
Monza
I.R.C.C.S. Istituto Oncologico Veneto -Oncologia 1
RECRUITING
Padua
Policlinico Giaccone - Ematologia
NOT_YET_RECRUITING
Palermo
Azienda USL Piacenza - UOC Ematologia e Centro Trapianti,
RECRUITING
Piacenza
Ospedale delle Croci - Ematologia
RECRUITING
Ravenna
Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia
RECRUITING
Reggio Emilia
Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapie Cellulari, Policlinico Universitario Campus Bio-Medico
NOT_YET_RECRUITING
Roma
AOU Senese - U.O.C. Ematologia
NOT_YET_RECRUITING
Siena
A.O.U. Città della Salute e della Scienza di Torino - Ematologia Universitaria
NOT_YET_RECRUITING
Torino
A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia
NOT_YET_RECRUITING
Torino
Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - S.C. Ematologia
RECRUITING
Trieste
AOU Integrata di Verona - U.O. Ematologia
NOT_YET_RECRUITING
Verona
Contact Information
Primary
Uffici Studi FIL
startup@filinf.it
+390131033153
Backup
Uffici Studi FIL
gestionestudi@filinf.it
+390599769913
Time Frame
Start Date: 2025-04-09
Estimated Completion Date: 2030-04
Participants
Target number of participants: 47
Treatments
Experimental: Rituximab in combination with Golcadomide (CC-99282)
Induction Phase (6 cycles every 28 days): Cycle 1 (Rituximab 375 mg/mq i.v. on days 1, 8, 15; Golcadomide 0,3 mg/day p.o. days 1-14; Dexamethasone 5 mg p.o. on days 1, 8, 15, 22). Cycles 2-6 (Rituximab 375 mg/mq i.v. on day 1; Golcadomide 0,4 mg/day p.o. days 1-14).~Consolidation phase (for patients achieving at least a partial response at the end of induction (≥PR), the consolidation phase will start within 6-8 weeks from Cycle 6 Day1 and will be continued up to 6 cycles every 28 days): golcadomide 0.2 mg / day p.o. days 1-14.~Consolidation radiotherapy: involved site radiotherapy (ISR) is allowed at the end of induction phase on PET positive sites, according to the available guidelines (Illidge et al., 2014). ISR should be concomitant to consolidation phase.
Related Therapeutic Areas
Sponsors
Leads: Fondazione Italiana Linfomi - ETS

This content was sourced from clinicaltrials.gov

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