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New treatment option for DLBCL
Official title Clinical Study of HiR+X Therapy for Newly Diagnosed Elderly Patients With DLBCL Intolerant to Chemotherapy
ClinicalTrials.gov ID: NCT06758037
What this study is testing
What is Drug therapy?
Drug therapy is an investigational medicine, being studied as a potential treatment for dlbcl.
Also referred to as Ocalivumab, Chidamide.
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
- To explore the application of HiR (Zebtorizumab, Lenalidomide) + X (targeted drug) guided by NGS molecular typing, the aim is to assess the therapeutic efficacy and safety in newly diagnosed unfit or frail elderly patients with DLBCL aged ≥70 years, and to investigate the genetic subtypes that may benefit from HiR-X.
- 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 70 to 100
You may be able to join if
- Age ≥ 70 years;
- ECOG score 0-3;
- Rated as "unfit" or "frail" on the simplified geriatric assessment (sGA);
- Histologically confirmed CD20-positive diffuse large B-cell lymphoma [diagnostic criteria according to WHO 2016], excluding transformed type 2 DLBCL;
- Previously untreated, newly diagnosed patients;
You likely can't join if
- Patients with central nervous system involvement at the onset of the disease;
- Known human immunodeficiency virus (HIV) infection;
- Pregnant or lactating women;
- Other tumors requiring treatment;
- Uncontrolled active infection;
- Active hepatitis with HBV-DNA copy number unable to be controlled within 2000/mL despite antiviral treatment;
See the full eligibility criteria
- Age ≥ 70 years;
- ECOG score 0-3;
- Rated as "unfit" or "frail" on the simplified geriatric assessment (sGA);
- Histologically confirmed CD20-positive diffuse large B-cell lymphoma [diagnostic criteria according to WHO 2016], excluding transformed type 2 DLBCL;
- Previously untreated, newly diagnosed patients;
- Cardiac, hepatic, and renal function: creatinine \< 2 times the upper limit of normal (ULN); ALT (alanine aminotransferase) / AST (aspartate aminotransferase) \< 2.5 x ULN; total bilirubin \< 2 x ULN;
- At least one measurable lesion;
- Intolerance to standard CHOP chemotherapy regimen or unwillingness to receive chemotherapy;
- Sufficient understanding and voluntary signing of the informed consent form.
- Patients with central nervous system involvement at the onset of the disease;
- Known human immunodeficiency virus (HIV) infection;
- Pregnant or lactating women;
- Other tumors requiring treatment;
- Uncontrolled active infection;
- Active hepatitis with HBV-DNA copy number unable to be controlled within 2000/mL despite antiviral treatment;
- Individuals who cannot understand, comply with the study protocol, or sign the informed consent form.
The study team makes the final eligibility decision.
Where it's taking place
- Ningbo, Zhejiang, China
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, 70 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ningbo, Zhejiang, China. 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.