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Clinical trial with a combination of Rituximab and Golcadomide as first line therapy for older frail patients with Diffuse Large B-cells non-Hodgkin Lymphoma
EU CTIS ID: 2023-506206-38-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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-specific procedures and able to understand and to comply with the requirements of the study and the schedule of assessments.
- 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)
- 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
You likely can't join if
- Histological diagnosis different from DLBCL
- Central nervous system (CNS) involvement with lymphoma
- Significant history of cardiac, neurologic, psychiatric, endocrinological, metabolic, immunologic, or hepatic disease that would preclude participation in the study or compromise ability to give informed consent
- 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 of the skin, previous malignancy confined and surgically resected with curative intent
- Evidence of other clinically significant uncontrolled condition(s) including, but not limited to: a. Uncontrolled and/or active systemic infection (viral, bacterial or fungal), including active ongoing infection from SARS-CoV-2; b. Chronic or acute hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV i.e. hepatitis B surface (HBs) antigen (Ag) negative, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative, may participate; patients with positive anti-HBc antibody from previous infection or inactive carriers are eligible only with HBV-DNA negative and with concomitant treatment with Lamivudine or Tenofovir; c. Patients with presence of HCV antibody are eligible only if PCR negative for HCV-RNA
- Human immunodeficiency virus (HIV) seropositivity
See the full eligibility criteria
Who can join
- 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.
- 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)
- 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 or agree to use specified contraceptive methods 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).
- 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 10^9/L with ANC > 1.0 x 10^9/L unless due to bone marrow involvement by lymphoma; Platelet count ≥ 75 x 10^9/L unless due to bone marrow involvement by lymphoma; Hemoglobin ≥ 10 g/dL unless anemia related to active lymphoma
What rules you out
- Histological diagnosis different from DLBCL
- Central nervous system (CNS) involvement with lymphoma
- Significant history of cardiac, neurologic, psychiatric, endocrinological, metabolic, immunologic, or hepatic disease that would preclude participation in the study or compromise ability to give informed consent
- 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 of the skin, previous malignancy confined and surgically resected with curative intent
- Evidence of other clinically significant uncontrolled condition(s) including, but not limited to: a. Uncontrolled and/or active systemic infection (viral, bacterial or fungal), including active ongoing infection from SARS-CoV-2; b. Chronic or acute hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV i.e. hepatitis B surface (HBs) antigen (Ag) negative, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative, may participate; patients with positive anti-HBc antibody from previous infection or inactive carriers are eligible only with HBV-DNA negative and with concomitant treatment with Lamivudine or Tenofovir; c. 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
The study team makes the final eligibility decision.
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, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.