Lenalidomide Combined With G-CHOP in the Treatment of Newly Diagnosed DLBCL With FL

Launched by THE FIRST AFFILIATED HOSPITAL OF XIAMEN UNIVERSITY · Nov 28, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients newly diagnosed with diffuse large B-cell lymphoma (DLBCL) that also has features of follicular lymphoma (FL). The researchers want to see how well lenalidomide works when combined with a standard treatment called G-CHOP, which includes different chemotherapy drugs. The goal is to understand both how effective this combination is and what side effects patients might experience.

To participate in this trial, you must be between 18 and 70 years old and have a specific type of lymphoma where both DLBCL and FL are present. You should have measurable signs of the disease and overall good health, with certain limits on conditions like heart function. Participants can expect to receive the combination treatment and will be closely monitored by medical professionals throughout the study. This trial aims to improve treatment options for patients with this complex form of lymphoma, and your involvement could help advance our understanding of how to better manage this disease.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age: 18-70 years old, gender is not limited;
• • 2. According to the REAL/WHO classification, the newly diagnosed diffuse large b-cell lymphoma with follicular lymphoma (CDLBCL-FL): the same lymph node specimen showed diffuse large b-cell lymphoma and follicular lymphoma, or the tissue specimen showed diffuse large b-cell lymphoma and indolent lymphoma in bone marrow pathology; or the different group specimens suggested diffuse large b-cell lymphoma and/or follicular lymphoma, respectively, with stage II-IV.
• • 3. Using the Lugano 2014 lymphoma response evaluation criteria, there must be at least one measurable or evaluable lesion: PET/CT can evaluate the lesion, CT or MRI can evaluate the lesion in the node with a diameter greater than 1.5 cm, a short diameter greater than 1.0 cm, or an extranodal lesion with a diameter greater than or equal to 1.0 cm
• • 4. ECOG 0-2
• • 5. Left ventricular ejection fraction (LVEF) was less than 45%
• • 6. HBV-positive serology (occult carriers: anti-HBeAg +, anti-HBsAg-, anti-HBsAg +/-) can only be enrolled if the HBV-dna test is negative.
• • 7. Normal major organ function: liver function: serum bilirubin ≤2.0 × ULN, serum ALT and AST ≤2.5 × ULN, renal function: serum CR ≤2.0 × ULN; (unless caused by lymphoma)
• • 8. Absolute neutrophil count (ANC)≥1.0 × 109 l, platelet count (PLT)≥100 × 109 L, hemoglobin content (HGB)≥80 g L, if myeloma was involved, ANC ≥0.75 × 109 L, platelet count (PLT)≥50 × 109 L, HGB content (HGB) was not required.
• • 9. Life expectancy ≥6 months
• • 10. Informed consent (all studies had to sign a patient's informed consent form)
• Exclusion Criteria:
• • 1. DLBCL of primary and secondary centers;
• • 2. HIV-positive patients and/or HCV-active infections (recorded through HCV-RNA-positive testing)
• • 3. Clinically evident secondary cardiovascular diseases such as uncontrollable hypertension (resting diastolic pressure\>115 mmHG), uncontrolled arrhythmias, symptomatic angina pectoris, or NYHA III-IV congestive heart failure.
• • 4. Severe chronic obstructive pulmonary disease complicated with hypoxemia.
• • 5. Active bacterial, fungal, and/or viral infections beyond the control of systemic therapy
• • 6. Except for cured skin basal cell carcinoma or cervical carcinoma in situ, or early prostate cancer that does not require systemic treatment or early breast cancer only requires surgery. Other malignant tumors have occurred within the past 3 years or at the same time