Combining lenalidomide with G-CHOP for treating newly diagnosed DLBCL with FL

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 Phase 2, open-label clinical trial evaluates the effectiveness and safety of lenalidomide in combination with G-CHOP (LO-CHOP) for patients newly diagnosed with diffuse large B-cell lymphoma and follicular lymphoma. The study aims to assess key outcomes such as complete response rates, overall survival, and progression-free survival, while also monitoring adverse effects associated with the treatment. Participants will undergo treatment and be closely monitored to determine the efficacy of this combined approach.

Why it matters

Who can join: the full rules

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

Where it's running

• Bing Xu
  Xiamen, Fujian, China Recruiting

Study contacts

• Principal investigator: Bing Xu, PhD — The First Aiffiliated hosptical of xiamen University
• Study coordinator: Bing Xu, PhD
• Email: xubingzhangjian@126.com
• Phone: +86 187 5091 8842

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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.