Clinical Study of HiR+X Therapy for Newly Diagnosed Elderly Patients with DLBCL Intolerant to Chemotherapy

Launched by FIRST AFFILIATED HOSPITAL OF NINGBO UNIVERSITY · Jan 2, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment option called HiR+X therapy for elderly patients who have recently been diagnosed with a type of cancer called diffuse large B-cell lymphoma (DLBCL). This study is specifically aimed at patients aged 70 and older who are considered "unfit" or "frail" for traditional chemotherapy. The goal is to see how effective and safe this new treatment is, especially for those whose cancer has certain genetic characteristics that may respond better to this therapy.

To participate in this trial, patients must be at least 70 years old, have a confirmed diagnosis of CD20-positive DLBCL, and show that they cannot tolerate standard chemotherapy. They should also have at least one measurable tumor and be in reasonable health regarding their heart, liver, and kidney functions. If eligible, participants can expect to receive the HiR+X therapy and will be closely monitored throughout the study to ensure their safety and to assess how well the treatment works. It's a chance for those who may not have many options to receive a potentially beneficial therapy tailored to their specific health needs.

Gender

ALL

Eligibility criteria

• 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.