Actively Recruiting
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)
Led by Fondazione Italiana Linfomi - ETS · Updated on 2026-01-02
47
Participants Needed
20
Research Sites
259 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide written informed consent and comply with study requirements
- Histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) per 2022 WHO classification
- Previously untreated for lymphoma
- Frail patients aged 80 years or older with limited daily living activities or significant comorbidities
- Not eligible for anthracycline-based chemotherapy
- Ann Arbor Stage I to IV disease
- ECOG performance status of 0 to 3
- At least one measurable lymph node of 1.5 cm or larger on CT scan
- Adequate blood counts: WBC > 2.5 x10^9/L, ANC > 1.0 x10^9/L, platelets ≥ 75 x10^9/L, hemoglobin ≥ 10 g/dL unless related to lymphoma
- Adequate kidney function with creatinine clearance ≥ 30 mL/min
- Adequate liver function with AST and ALT ≤ 2 times upper limit of normal and bilirubin ≤ 2 times upper limit of normal unless due to Gilbert's syndrome or non-hepatic causes
- Able to follow study visit schedule and requirements
- Able to swallow capsules or tablets
- Life expectancy of at least 3 months
- Male subjects must agree to complete abstinence or use barrier contraception during study and for 28 days after last dose
You will not qualify if you...
- Diagnosis other than diffuse large B-cell lymphoma (DLBCL)
- Lymphoma involvement of the central nervous system
- Severe heart failure (NYHA class III-IV) or left ventricular ejection fraction less than 45%
- Severe liver disease (Child Pugh C), interstitial lung disease, pneumonitis, pulmonary fibrosis, or oxygen saturation below 92% on room air
- Any condition preventing informed consent or study participation
- History of other active cancers within 5 years except certain treated skin or cervical cancers
- Gastrointestinal conditions affecting drug absorption such as gastric bypass or gastrectomy
- Uncontrolled infections including active COVID-19
- Active hepatitis B or C requiring treatment; certain inactive or treated hepatitis cases allowed with conditions
- HIV infection
- Lack of caregiver support for non-autonomous patients
- Allergy or intolerance to study drugs or their ingredients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
AOU SS. Antonio e Biagio e Cesare Arrigo di Alessandria - SCDU Ematologia
Alessandria, Italy, 15121
Actively Recruiting
2
AOU Ospedali Riuniti - Clinica di Ematologia
Ancona, Italy
Actively Recruiting
3
Azienda Ospedaliera S. Giuseppe Moscati - S.C. Ematologia e trapianto emopoietico
Avellino, Italy
Actively Recruiting
4
Ospedale IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuno-correlati
Aviano, Italy
Actively Recruiting
5
ASST Spedali Civili di Brescia - Ematologia
Brescia, Italy
Actively Recruiting
6
Azienda Ospedaliera Universitaria Careggi -Unità Funzionale di Ematologia
Florence, Italy
Actively Recruiting
7
ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia
Milan, Italy
Actively Recruiting
8
Fondazione IRCCS San Gerardo dei Tintori -Ematologia
Monza, Italy
Actively Recruiting
9
I.R.C.C.S. Istituto Oncologico Veneto -Oncologia 1
Padova, Italy
Actively Recruiting
10
Policlinico Giaccone - Ematologia
Palermo, Italy
Not Yet Recruiting
11
Azienda Sanitaria Locale di Pescara- Presidio Ospedaliero Santo Spirito - U.O.C. Ematologia
Pescara, Italy, 65128
Not Yet Recruiting
12
Azienda USL Piacenza - UOC Ematologia e Centro Trapianti,
Piacenza, Italy
Actively Recruiting
13
Ospedale delle Croci - Ematologia
Ravenna, Italy
Actively Recruiting
14
Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia
Reggio Emilia, Italy
Actively Recruiting
15
Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapie Cellulari, Policlinico Universitario Campus Bio-Medico
Roma, Italy
Actively Recruiting
16
AOU Senese - U.O.C. Ematologia
Siena, Italy
Not Yet Recruiting
17
A.O.U. Città della Salute e della Scienza di Torino - Ematologia Universitaria
Torino, Italy
Actively Recruiting
18
A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia
Torino, Italy
Actively Recruiting
19
Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - S.C. Ematologia
Trieste, Italy
Actively Recruiting
20
AOU Integrata di Verona - U.O. Ematologia
Verona, Italy
Actively Recruiting
Research Team
U
Uffici Studi FIL
CONTACT
U
Uffici Studi FIL
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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