Treatment for elderly patients with DLBCL who can't tolerate chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study investigates the effectiveness and safety of a combination therapy called HiR+X, which includes Zebtorizumab and Lenalidomide, for elderly patients aged 70 and older who have been newly diagnosed with diffuse large B-cell lymphoma (DLBCL) and are considered unfit for standard chemotherapy. The approach is guided by next-generation sequencing (NGS) molecular typing to identify genetic subtypes that may respond better to the treatment. The study aims to provide an alternative therapeutic option for this vulnerable patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 70 years;
2. ECOG score 0-3;
3. Rated as "unfit" or "frail" on the simplified geriatric assessment (sGA);
4. Histologically confirmed CD20-positive diffuse large B-cell lymphoma \[diagnostic criteria according to WHO 2016\], excluding transformed type 2 DLBCL;
5. Previously untreated, newly diagnosed patients;
6. 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;
7. At least one measurable lesion;
8. Intolerance to standard CHOP chemotherapy regimen or unwillingness to receive chemotherapy;
9. Sufficient understanding and voluntary signing of the informed consent form.

Exclusion Criteria:

1. Patients with central nervous system involvement at the onset of the disease;
2. Known human immunodeficiency virus (HIV) infection;
3. Pregnant or lactating women;
4. Other tumors requiring treatment;
5. Uncontrolled active infection;
6. Active hepatitis with HBV-DNA copy number unable to be controlled within 2000/mL despite antiviral treatment;
7. Individuals who cannot understand, comply with the study protocol, or sign the informed consent form.

Where it's running

• The First Affiliated Hospital of Ningbo University
  Ningbo, Zhejiang, China Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Predicting response to first-line DLBCL treatment using ctDNA and PET/CT

  This project will test whether combining a blood ctDNA test with PET/CT scans after two treatment cycles can predict treatment response in people newly diagnosed with DLBCL who are starting standard first-line therapy.

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  This study is testing a new treatment called zilovertamab vedotin for adults with relapsed or refractory diffuse large B-cell lymphoma to see if it works better than standard care.

  Recruiting at 43 sites Phase 2/3 Merck Sharp & Dohme LLC · Glendale, Arizona and 134 other locations · NCT05139017

• Comparing two treatments for elderly patients with diffuse large B-cell lymphoma

  This study is testing whether a new treatment for elderly patients with diffuse large B-cell lymphoma works better than the standard treatment.

  Recruiting at 52 sites Phase 3 Nordic Lymphoma Group · Albury and 68 other locations · NCT04332822

• Combining acalabrutinib with standard chemotherapy for untreated aggressive B-cell lymphoma

  This study is testing if adding a new drug called acalabrutinib to standard chemotherapy can help people with untreated aggressive B-cell lymphoma get better results.

  Recruiting Phase 2 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT04002947

• Polatuzumab Vedotin plus Rituximab with Reduced-dose chemo for frail seniors with DLBCL

  This trial tests whether a gentler, first-line treatment (Polatuzumab Vedotin with Rituximab and reduced-dose chemo) helps older, frail patients with DLBCL stay disease-free longer.

  Recruiting Phase 4 The First Hospital of Jilin University · Changchun, Jilin · NCT07908888

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.