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New treatment option for Diffuse Large B Cell Non-Hodgkin Lymphoma
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)
ClinicalTrials.gov ID: NCT06835530
What this study is testing
What is Rituximab + Golcadomide (CC-99282)?
Rituximab + Golcadomide (CC-99282) is an investigational medicine, being studied as a potential treatment for diffuse large b cell non-hodgkin lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 80 and older
You may be able to join if
- Able to provide written informed consent form approved by the National Ethics Committee (NEC) prior to the initiation of any screening or study-...
- 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) \ 5 comorbidities of grade 2 and/or one or more...
- Patient not eligible to anthracycline-based chemotherapy
You likely can't join if
- Histological diagnosis different from DLBCL
- Central nervous system (CNS) involvement with lymphoma
- Severe heart failure (NYHA grado III-IV and/or LVEF \< 45%), liver disease Child Pugh C, history of interstitial lung disease, non-infectious...
- Any history of other active malignancies within 5 years prior to study entry, except for adequately treated in situ carcinoma of the cervix uterine...
- Gastrointestinal dysfunction that may affect drug absorption (eg, gastric bypass surgery, gastrectomy) or any other malabsorption condition
- Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
See the full eligibility criteria
- 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...
- 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) \ 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 people 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...
- Histological diagnosis different from DLBCL
- Central nervous system (CNS) involvement with lymphoma
- Severe heart failure (NYHA grado III-IV and/or LVEF \< 45%), liver disease Child Pugh C, history of interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis, or pulse oximetry of \< 92% while breathing...
- Any history of other active malignancies within 5 years prior to study entry, except for adequately treated in situ carcinoma of the cervix uterine, basal cell carcinoma of the skin or localized squamous cell carcinoma...
- Gastrointestinal dysfunction that may affect drug absorption (eg, gastric bypass surgery, gastrectomy) or any other malabsorption condition
- Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
- Uncontrolled and/or active systemic infection (viral, bacterial or fungal), including active ongoing infection from SARS-CoV-2
- Chronic or acute hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: people with serologic evidence of prior vaccination to HBV i.e. hepatitis B surface (HBs) antigen (Ag) negative, anti-HBs antibody...
- Patients with presence of HCV antibody are eligible only if PCR negative for HCV-RNA
- Human immunodeficiency virus (HIV) seropositivity
- Absence of caregivers in non-autonomous patients
- Allergy or intolerance to the active or inactive ingredients of study drugs
The study team makes the final eligibility decision.
Where it's taking place
- Alessandria, Italy
- Ancona, Italy
- Avellino, Italy
- Aviano, Italy
- Brescia, Italy
- Florence, Italy
- Milan, Italy
- Monza, Italy
- Padova, Italy
- Palermo, Italy
- Pescara, Italy
- Piacenza, Italy
- Ravenna, Italy
- Reggio Emilia, Italy
- Roma, Italy
- Siena, Italy
- Torino, Italy
- Trieste, Italy
- Verona, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 80 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Alessandria, Italy; Ancona, Italy; Avellino, Italy; Aviano, Italy; Brescia, Italy; Florence, Italy and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.